PARTNERPRØVEN: Plassering av Aortic TraNscatheter Valve Trial (PARTNER)
14. august 2017 oppdatert av: Edwards Lifesciences
PARTNERPRØVEN: Plassering av Aortic Transcatheter Valve Trial Edwards SAPIEN Transcatheter Heart Valve
Formålet med denne studien er å bestemme sikkerheten og effektiviteten til enheten og leveringssystemene (transfemorale og transapikale) hos symptomatiske pasienter med høy risiko med alvorlig aortastenose.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Forsøkspersonene vil gjennomgå en fysisk undersøkelse og screeningtester vil bli utført for å avgjøre om de enten A) er en pasient med høy kirurgisk risiko eller B) ikke er en kandidat for kirurgi.
De vil deretter bli randomisert (som en mynt) for å få undersøkelsesutstyret implantert eller for å motta gjeldende kirurgisk eller medisinsk behandling som er tilgjengelig.
Studietype
Intervensjonell
Registrering (Faktiske)
1057
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Quebec, Canada, G1V 4G5
- Laval Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Vancouver St. Paul's
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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California
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La Jolla, California, Forente stater, 92037
- Scripps Memorial Hospital/Scripps Green Hospital
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Los Angeles, California, Forente stater, 90048
- Cedars Sinai Medical Center
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Stanford, California, Forente stater, 94305
- Stanford University Medical Center
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District of Columbia
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Washington, D.C., District of Columbia, Forente stater, 20010
- Washington Hospital Center
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Florida
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Miami, Florida, Forente stater, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern University
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Evanston, Illinois, Forente stater, 60201
- Northshore University Healthsystem
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Louisiana
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New Orleans, Louisiana, Forente stater, 70121
- Ochsner Clinic
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's
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Boston, Massachusetts, Forente stater, 02114
- Boston Mass General
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic-Saint Marys Hospital
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- St. Luke's Hospital of Kansas City
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Saint Louis, Missouri, Forente stater, 63110
- Barnes-Jewish/Washington University
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New York
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New York, New York, Forente stater, 10032
- Columbia University Medical Center
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New York, New York, Forente stater, 10021
- New York Presbyterian Hospital - Cornell
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- The Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania
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Texas
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Dallas, Texas, Forente stater, 75230
- Medical City Dallas
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Utah
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Murray, Utah, Forente stater, 84157
- Intermountain Medical Center
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Virginia
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Charlottesville, Virginia, Forente stater, 22908
- University of Virginia
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Washington
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Seattle, Washington, Forente stater, 98101
- University of Washington
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Leipzig, Tyskland, 04289
- Heart Center Leipzig
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inkluderingskriterier Kohort A
- Pasienter må ha komorbiditeter slik at co-PI-er for kirurgen og kardiologen er enige om at den anslåtte risikoen for operasjonsdødelighet er ≥15 % og/eller en minimum STS-score på 10
- Pasienten har senil degenerativ aortaklaffstenose med ekkokardiografisk avledede kriterier: gjennomsnittlig gradient >40 mmHg eller jethastighet større enn 4,0 m/s eller et initialt aortaklaffareal på < 0,8 cm2
- Pasienten er symptomatisk fra hans/hennes aortaklaffstenose, som demonstrert av NYHA Functional Class II eller høyere
- Forsøkspersonen eller forsøkspersonens juridiske representant har blitt informert om studiens art, godtar bestemmelsene og har gitt skriftlig informert samtykke som godkjent av IRB på det respektive kliniske stedet
Forsøkspersonen og behandlende lege er enige om at forsøkspersonen kommer tilbake for alle nødvendige oppfølgingsbesøk etter prosedyren
Kohort B Alle kandidater til kohort B i denne studien må oppfylle #2, 3, 4, 5 av kriteriene ovenfor og
- Observanden, etter formelle konsultasjoner av en kardiolog og to kardiovaskulære kirurger, er enige om at medisinske faktorer utelukker operasjon, basert på en konklusjon om at sannsynligheten for død eller alvorlig, irreversibel sykelighet overstiger sannsynligheten for meningsfull forbedring. Nærmere bestemt bør sannsynligheten for død eller alvorlig, irreversibel sykelighet overstige 50 %.
Eksklusjonskriterier
- Bevis på et akutt hjerteinfarkt ≤ 1 måned før tiltenkt behandling.
- Aortaklaff er en medfødt unicuspid- eller bikuspidalklaff; eller er ikke-kalsifisert
- Blandet aortaklaffsykdom (aortastenose og aorta-regurgitasjon med dominerende aorta-regurgitasjon >3+).
- Enhver terapeutisk invasiv hjerteprosedyre utført innen 30 dager etter indeksprosedyren, (eller 6 måneder hvis prosedyren var en medikamenteluerende koronar stentimplantasjon).
- Eksisterende hjerteklaffprotese i enhver posisjon, protesering eller alvorlig (større enn 3+) mitralsvikt.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 1
Kohort A: Sapien-ventil
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Aktiv komparator: 2
Kohort A: annen kirurgisk ventil
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Eksperimentell: 3
Kohort B: Sapien-ventil
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Aktiv komparator: 4
Kohort B: Medisinsk terapi
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Død
Tidsramme: 1 år
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Død uansett årsak.
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1 år
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Sammensetning av død og tilbakevendende sykehusinnleggelse.
Tidsramme: varighet av studiet
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Død av enhver årsak eller gjentatt sykehusinnleggelse etter intervensjon.
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varighet av studiet
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Funksjonell endring av NYHA
Tidsramme: Baseline til 1 år
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NYHA-klassifiseringsendring fra baseline til 1 års besøk.
NYHA gir en måte å klassifisere omfanget av hjertesvikt.
New York Heart Association (NYHA) er en funksjonell klassifisering av hjertesvikt basert på hvor mye en pasient er begrenset under fysisk aktivitet.
Rangeringen varierer fra I - IV, med den laveste (I) som ingen begrensninger og den høyeste (IV) som ikke er i stand til å utføre fysisk aktivitet uten ubehag.
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Baseline til 1 år
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Antall deltakere med alvorlige uønskede hjerte- og cerebrovaskulære hendelser (MACCE)
Tidsramme: 1 år
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Antall deltakere med MACCE-definisjon inkluderer død, hjerteinfarkt (MI), hjerneslag og nyresvikt
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1 år
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Totalt antall sykehusdager fra indeksprosedyren
Tidsramme: 1 år
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Totalt antall sykehusdager fra indeksprosedyren eller randomiseringen til kontrollarmen til ett år etter prosedyren eller randomiseringen.
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1 år
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Endring i livskvalitet (QOL) fra baseline til 1 år
Tidsramme: Grunnlinje og 1 år
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QOL-spørreskjemaet besto av: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - fysiske og metalliske tilstander. KCCQ-score er på et område på 0-100, der 100 reflekterer den beste helsestatusen og 0 reflekterer den dårligste helsestatusen. SF-12 spørreskjema ble brukt der 100 gjenspeiler den beste helsetilstanden og 0 gjenspeiler den dårligste helsetilstanden. |
Grunnlinje og 1 år
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Martin B Leon, MD, New York-Presbyterian Hospital/Columbia University Medical Center
- Hovedetterforsker: Craig Smith, MD, New York-Presbyterian Hospital/Columbia University Medical Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Vincent F, Thourani VH, Ternacle J, Redfors B, Cohen DJ, Hahn RT, Li D, Crowley A, Webb JG, Mack MJ, Kapadia S, Russo M, Smith CR, Alu MC, Leon MB, Pibarot P. Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials. Circ Cardiovasc Qual Outcomes. 2022 Jan;15(1):e007948. doi: 10.1161/CIRCOUTCOMES.121.007948. Epub 2022 Jan 18.
- Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.
- Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.
- Kapadia SR, Huded CP, Kodali SK, Svensson LG, Tuzcu EM, Baron SJ, Cohen DJ, Miller DC, Thourani VH, Herrmann HC, Mack MJ, Szerlip M, Makkar RR, Webb JG, Smith CR, Rajeswaran J, Blackstone EH, Leon MB; PARTNER Trial Investigators. Stroke After Surgical Versus Transfemoral Transcatheter Aortic Valve Replacement in the PARTNER Trial. J Am Coll Cardiol. 2018 Nov 13;72(20):2415-2426. doi: 10.1016/j.jacc.2018.08.2172.
- Elmariah S, Fearon WF, Inglessis I, Vlahakes GJ, Lindman BR, Alu MC, Crowley A, Kodali S, Leon MB, Svensson L, Pibarot P, Hahn RT, Thourani VH, Palacios IF, Miller DC, Douglas PS, Passeri JJ; PARTNER Trial Investigators and PARTNER Publications Office. Transapical Transcatheter Aortic Valve Replacement Is Associated With Increased Cardiac Mortality in Patients With Left Ventricular Dysfunction: Insights From the PARTNER I Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2414-2422. doi: 10.1016/j.jcin.2017.09.023.
- Douglas PS, Leon MB, Mack MJ, Svensson LG, Webb JG, Hahn RT, Pibarot P, Weissman NJ, Miller DC, Kapadia S, Herrmann HC, Kodali SK, Makkar RR, Thourani VH, Lerakis S, Lowry AM, Rajeswaran J, Finn MT, Alu MC, Smith CR, Blackstone EH; PARTNER Trial Investigators. Longitudinal Hemodynamics of Transcatheter and Surgical Aortic Valves in the PARTNER Trial. JAMA Cardiol. 2017 Nov 1;2(11):1197-1206. doi: 10.1001/jamacardio.2017.3306.
- Lindman BR, Otto CM, Douglas PS, Hahn RT, Elmariah S, Weissman NJ, Stewart WJ, Ayele GM, Zhang F, Zajarias A, Maniar HS, Jilaihawi H, Blackstone E, Chinnakondepalli KM, Tuzcu EM, Leon MB, Pibarot P. Blood Pressure and Arterial Load After Transcatheter Aortic Valve Replacement for Aortic Stenosis. Circ Cardiovasc Imaging. 2017 Jul;10(7):e006308. doi: 10.1161/CIRCIMAGING.116.006308.
- Beohar N, Doshi D, Thourani V, Jensen H, Kodali S, Zhang F, Zhang Y, Davidson C, McCarthy P, Mack M, Kapadia S, Leon M, Kirtane A. Association of Transcatheter Aortic Valve Replacement With 30-Day Renal Function and 1-Year Outcomes Among Patients Presenting With Compromised Baseline Renal Function: Experience From the PARTNER 1 Trial and Registry. JAMA Cardiol. 2017 Jul 1;2(7):742-749. doi: 10.1001/jamacardio.2017.1220.
- Daubert MA, Weissman NJ, Hahn RT, Pibarot P, Parvataneni R, Mack MJ, Svensson LG, Gopal D, Kapadia S, Siegel RJ, Kodali SK, Szeto WY, Makkar R, Leon MB, Douglas PS. Long-Term Valve Performance of TAVR and SAVR: A Report From the PARTNER I Trial. JACC Cardiovasc Imaging. 2016 Dec 8:S1936-878X(16)30895-6. doi: 10.1016/j.jcmg.2016.11.004. Online ahead of print.
- Kapadia S, Agarwal S, Miller DC, Webb JG, Mack M, Ellis S, Herrmann HC, Pichard AD, Tuzcu EM, Svensson LG, Smith CR, Rajeswaran J, Ehrlinger J, Kodali S, Makkar R, Thourani VH, Blackstone EH, Leon MB. Insights Into Timing, Risk Factors, and Outcomes of Stroke and Transient Ischemic Attack After Transcatheter Aortic Valve Replacement in the PARTNER Trial (Placement of Aortic Transcatheter Valves). Circ Cardiovasc Interv. 2016 Sep;9(9):e002981. doi: 10.1161/CIRCINTERVENTIONS.115.002981.
- Anjan VY, Herrmann HC, Pibarot P, Stewart WJ, Kapadia S, Tuzcu EM, Babaliaros V, Thourani VH, Szeto WY, Bavaria JE, Kodali S, Hahn RT, Williams M, Miller DC, Douglas PS, Leon MB. Evaluation of Flow After Transcatheter Aortic Valve Replacement in Patients With Low-Flow Aortic Stenosis: A Secondary Analysis of the PARTNER Randomized Clinical Trial. JAMA Cardiol. 2016 Aug 1;1(5):584-92. doi: 10.1001/jamacardio.2016.0759. Erratum In: JAMA Cardiol. 2019 Feb 1;4(2):189.
- Suri RM, Minha S, Alli O, Waksman R, Rihal CS, Satler LP, Greason KL, Torguson R, Pichard AD, Mack M, Svensson LG, Rajeswaran J, Lowry AM, Ehrlinger J, Mick SL, Tuzcu EM, Thourani VH, Makkar R, Holmes D, Leon MB, Blackstone EH. Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety. J Thorac Cardiovasc Surg. 2016 Sep;152(3):773-780.e14. doi: 10.1016/j.jtcvs.2016.04.028. Epub 2016 Apr 13.
- Kodali S, Williams MR, Doshi D, Hahn RT, Humphries KH, Nkomo VT, Cohen DJ, Douglas PS, Mack M, Xu K, Svensson L, Thourani VH, Tuzcu EM, Weissman NJ, Leon M, Kirtane AJ. Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study. Ann Intern Med. 2016 Mar 15;164(6):377-84. doi: 10.7326/M15-0121. Epub 2016 Feb 23.
- Beohar N, Kirtane AJ, Blackstone E, Waksman R, Holmes D Jr, Minha S, Alli O, Suri RM, Svensson LG, Leon M, Kodali S. Trends in Complications and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Experience From the PARTNER Continued Access Registry. JACC Cardiovasc Interv. 2016 Feb 22;9(4):355-363. doi: 10.1016/j.jcin.2015.10.050. Epub 2016 Jan 20.
- Biviano AB, Nazif T, Dizon J, Garan H, Fleitman J, Hassan D, Kapadia S, Babaliaros V, Xu K, Parvataneni R, Rodes-Cabau J, Szeto WY, Fearon WF, Dvir D, Dewey T, Williams M, Mack MJ, Webb JG, Miller DC, Smith CR, Leon MB, Kodali S. Atrial Fibrillation Is Associated With Increased Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the Placement of Aortic Transcatheter Valve (PARTNER) Trial. Circ Cardiovasc Interv. 2016 Jan;9(1):e002766. doi: 10.1161/CIRCINTERVENTIONS.115.002766.
- Lindman BR, Zajarias A, Maniar HS, Miller DC, Suri RM, Arnold SV, Webb J, Svensson LG, Kodali S, Xu K, Ayele GM, Lin F, Wong SC, Babaliaros V, Thourani VH, Douglas PS, Lim S, Leon MB, Mack MJ. Risk stratification in patients with pulmonary hypertension undergoing transcatheter aortic valve replacement. Heart. 2015 Oct;101(20):1656-64. doi: 10.1136/heartjnl-2015-308001. Epub 2015 Aug 11.
- Dizon JM, Nazif TM, Hess PL, Biviano A, Garan H, Douglas PS, Kapadia S, Babaliaros V, Herrmann HC, Szeto WY, Jilaihawi H, Fearon WF, Tuzcu EM, Pichard AD, Makkar R, Williams M, Hahn RT, Xu K, Smith CR, Leon MB, Kodali SK; PARTNER Publications Office. Chronic pacing and adverse outcomes after transcatheter aortic valve implantation. Heart. 2015 Oct;101(20):1665-71. doi: 10.1136/heartjnl-2015-307666. Epub 2015 Aug 10.
- Thourani VH, Jensen HA, Babaliaros V, Kodali SK, Rajeswaran J, Ehrlinger J, Blackstone EH, Suri RM, Don CW, Aldea G, Williams MR, Makkar R, Svensson LG, McCabe JM, Dean LS, Kapadia S, Cohen DJ, Pichard AD, Szeto WY, Herrmann HC, Devireddy C, Leshnower BG, Ailawadi G, Maniar HS, Hahn RT, Leon MB, Mack M. Outcomes in Nonagenarians Undergoing Transcatheter Aortic Valve Replacement in the PARTNER-I Trial. Ann Thorac Surg. 2015 Sep;100(3):785-92; discussion 793. doi: 10.1016/j.athoracsur.2015.05.021. Epub 2015 Aug 1.
- Szeto WY, Svensson LG, Rajeswaran J, Ehrlinger J, Suri RM, Smith CR, Mack M, Miller DC, McCarthy PM, Bavaria JE, Cohn LH, Corso PJ, Guyton RA, Thourani VH, Lytle BW, Williams MR, Webb JG, Kapadia S, Tuzcu EM, Cohen DJ, Schaff HV, Leon MB, Blackstone EH; Placement of Aortic Transcatheter Valves Trial Investigators. Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial. J Thorac Cardiovasc Surg. 2015 Sep;150(3):557-68.e11. doi: 10.1016/j.jtcvs.2015.05.073. Epub 2015 Jun 30.
- Gada H, Kirtane AJ, Wang K, Lei Y, Magnuson E, Reynolds MR, Williams MR, Kodali S, Vahl TP, Arnold SV, Leon MB, Thourani V, Szeto WY, Cohen DJ; PARTNER Investigators. Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement: A Placement of AoRTic TraNscathetER Valve (PARTNER) Trial Substudy. Circ Cardiovasc Qual Outcomes. 2015 Jul;8(4):338-46. doi: 10.1161/CIRCOUTCOMES.114.001335. Epub 2015 Jun 9.
- Green P, Arnold SV, Cohen DJ, Kirtane AJ, Kodali SK, Brown DL, Rihal CS, Xu K, Lei Y, Hawkey MC, Kim RJ, Alu MC, Leon MB, Mack MJ. Relation of frailty to outcomes after transcatheter aortic valve replacement (from the PARTNER trial). Am J Cardiol. 2015 Jul 15;116(2):264-9. doi: 10.1016/j.amjcard.2015.03.061. Epub 2015 Apr 18.
- Blackstone EH, Suri RM, Rajeswaran J, Babaliaros V, Douglas PS, Fearon WF, Miller DC, Hahn RT, Kapadia S, Kirtane AJ, Kodali SK, Mack M, Szeto WY, Thourani VH, Tuzcu EM, Williams MR, Akin JJ, Leon MB, Svensson LG. Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a placement of aortic transcatheter valves (PARTNER)-I trial substudy. Circulation. 2015 Jun 2;131(22):1989-2000. doi: 10.1161/CIRCULATIONAHA.114.012525. Epub 2015 Apr 1.
- Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, Webb JG, Douglas PS, Anderson WN, Blackstone EH, Kodali SK, Makkar RR, Fontana GP, Kapadia S, Bavaria J, Hahn RT, Thourani VH, Babaliaros V, Pichard A, Herrmann HC, Brown DL, Williams M, Akin J, Davidson MJ, Svensson LG; PARTNER 1 trial investigators. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015 Jun 20;385(9986):2477-84. doi: 10.1016/S0140-6736(15)60308-7. Epub 2015 Mar 15.
- Kapadia SR, Leon MB, Makkar RR, Tuzcu EM, Svensson LG, Kodali S, Webb JG, Mack MJ, Douglas PS, Thourani VH, Babaliaros VC, Herrmann HC, Szeto WY, Pichard AD, Williams MR, Fontana GP, Miller DC, Anderson WN, Akin JJ, Davidson MJ, Smith CR; PARTNER trial investigators. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015 Jun 20;385(9986):2485-91. doi: 10.1016/S0140-6736(15)60290-2. Epub 2015 Mar 15.
- Kapadia S, Stewart WJ, Anderson WN, Babaliaros V, Feldman T, Cohen DJ, Douglas PS, Makkar RR, Svensson LG, Webb JG, Wong SC, Brown DL, Miller DC, Moses JW, Smith CR, Leon MB, Tuzcu EM. Outcomes of inoperable symptomatic aortic stenosis patients not undergoing aortic valve replacement: insight into the impact of balloon aortic valvuloplasty from the PARTNER trial (Placement of AoRtic TraNscathetER Valve trial). JACC Cardiovasc Interv. 2015 Feb;8(2):324-333. doi: 10.1016/j.jcin.2014.08.015.
- Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK; PARTNER Publications Office. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9. doi: 10.1016/j.jcin.2014.07.022.
- Passeri JJ, Elmariah S, Xu K, Inglessis I, Baker JN, Alu M, Kodali S, Leon MB, Svensson LG, Pibarot P, Fearon WF, Kirtane AJ, Vlahakes GJ, Palacios IF, Douglas PS; PARTNER Investigators. Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF. Heart. 2015 Mar;101(6):463-71. doi: 10.1136/heartjnl-2014-306737. Epub 2015 Jan 13.
- Genereux P, Cohen DJ, Mack M, Rodes-Cabau J, Yadav M, Xu K, Parvataneni R, Hahn R, Kodali SK, Webb JG, Leon MB. Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. J Am Coll Cardiol. 2014 Dec 23;64(24):2605-2615. doi: 10.1016/j.jacc.2014.08.052.
- Fearon WF, Kodali S, Doshi D, Fischbein MP, Yeung AC, Tuzcu EM, Rihal CS, Babaliaros V, Zajarias A, Herrmann HC, Brown DL, Mack M, Teirstein PS, Whisenant BK, Makkar R, Kapadia S, Leon MB; PARTNER Trial Investigators. Outcomes after transfemoral transcatheter aortic valve replacement: a comparison of the randomized PARTNER (Placement of AoRTic TraNscathetER Valves) trial with the NRCA (Nonrandomized Continued Access) registry. JACC Cardiovasc Interv. 2014 Nov;7(11):1245-51. doi: 10.1016/j.jcin.2014.05.033. Epub 2014 Nov 17.
- Douglas PS, Hahn RT, Pibarot P, Weissman NJ, Stewart WJ, Xu K, Wang Z, Lerakis S, Siegel R, Thompson C, Gopal D, Keane MG, Svensson LG, Tuzcu EM, Smith CR, Leon MB. Hemodynamic outcomes of transcatheter aortic valve replacement and medical management in severe, inoperable aortic stenosis: a longitudinal echocardiographic study of cohort B of the PARTNER trial. J Am Soc Echocardiogr. 2015 Feb;28(2):210-7.e1-9. doi: 10.1016/j.echo.2014.10.009. Epub 2014 Nov 20.
- Arnold SV, Lei Y, Reynolds MR, Magnuson EA, Suri RM, Tuzcu EM, Petersen JL 2nd, Douglas PS, Svensson LG, Gada H, Thourani VH, Kodali SK, Mack MJ, Leon MB, Cohen DJ; PARTNER Investigators. Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: results from the Placement of Aortic Transcatheter Valve trial. Circ Cardiovasc Interv. 2014 Dec;7(6):829-36. doi: 10.1161/CIRCINTERVENTIONS.114.001395. Epub 2014 Oct 21.
- Rodes-Cabau J, Pibarot P, Suri RM, Kodali S, Thourani VH, Szeto WY, Svensson LG, Dumont E, Xu K, Hahn RT, Leon MB. Impact of aortic annulus size on valve hemodynamics and clinical outcomes after transcatheter and surgical aortic valve replacement: insights from the PARTNER Trial. Circ Cardiovasc Interv. 2014 Oct;7(5):701-11. doi: 10.1161/CIRCINTERVENTIONS.114.001681. Epub 2014 Sep 30.
- Pibarot P, Weissman NJ, Stewart WJ, Hahn RT, Lindman BR, McAndrew T, Kodali SK, Mack MJ, Thourani VH, Miller DC, Svensson LG, Herrmann HC, Smith CR, Rodes-Cabau J, Webb J, Lim S, Xu K, Hueter I, Douglas PS, Leon MB. Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis. J Am Coll Cardiol. 2014 Sep 30;64(13):1323-34. doi: 10.1016/j.jacc.2014.06.1195.
- Kapadia SR, Tuzcu EM, Makkar RR, Svensson LG, Agarwal S, Kodali S, Fontana GP, Webb JG, Mack M, Thourani VH, Babaliaros VC, Herrmann HC, Szeto W, Pichard AD, Williams MR, Anderson WN, Akin JJ, Miller DC, Smith CR, Leon MB. Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy. Circulation. 2014 Oct 21;130(17):1483-92. doi: 10.1161/CIRCULATIONAHA.114.009834. Epub 2014 Sep 9.
- Svensson LG, Blackstone EH, Rajeswaran J, Brozzi N, Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Tuzcu EM, Webb JG, Kapadia S, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Thourani VH, Pichard AD, Bavaria JE, Herrmann HC, Williams MR, Babaliaros V, Genereux P, Akin JJ; PARTNER Trial Investigators. Comprehensive analysis of mortality among patients undergoing TAVR: results of the PARTNER trial. J Am Coll Cardiol. 2014 Jul 15;64(2):158-68. doi: 10.1016/j.jacc.2013.08.1666.
- Arnold SV, Reynolds MR, Lei Y, Magnuson EA, Kirtane AJ, Kodali SK, Zajarias A, Thourani VH, Green P, Rodes-Cabau J, Beohar N, Mack MJ, Leon MB, Cohen DJ; PARTNER Investigators. Predictors of poor outcomes after transcatheter aortic valve replacement: results from the PARTNER (Placement of Aortic Transcatheter Valve) trial. Circulation. 2014 Jun 24;129(25):2682-90. doi: 10.1161/CIRCULATIONAHA.113.007477. Epub 2014 May 23.
- Beohar N, Whisenant B, Kirtane AJ, Leon MB, Tuzcu EM, Makkar R, Svensson LG, Miller DC, Smith CR, Pichard AD, Herrmann HC, Thourani VH, Szeto WY, Lim S, Fischbein M, Fearon WF, O'Neill W, Xu K, Dewey T, Mack M. The relative performance characteristics of the logistic European System for Cardiac Operative Risk Evaluation score and the Society of Thoracic Surgeons score in the Placement of Aortic Transcatheter Valves trial. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2830-7.e1. doi: 10.1016/j.jtcvs.2014.04.006. Epub 2014 Apr 13.
- Williams M, Kodali SK, Hahn RT, Humphries KH, Nkomo VT, Cohen DJ, Douglas PS, Mack M, McAndrew TC, Svensson L, Thourani VH, Tuzcu EM, Weissman NJ, Kirtane AJ, Leon MB. Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the PARTNER Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014 Apr 22;63(15):1522-8. doi: 10.1016/j.jacc.2014.01.036. Epub 2014 Feb 19.
- Genereux P, Cohen DJ, Williams MR, Mack M, Kodali SK, Svensson LG, Kirtane AJ, Xu K, McAndrew TC, Makkar R, Smith CR, Leon MB. Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014 Mar 25;63(11):1100-9. doi: 10.1016/j.jacc.2013.10.058. Epub 2013 Nov 27.
- Lindman BR, Pibarot P, Arnold SV, Suri RM, McAndrew TC, Maniar HS, Zajarias A, Kodali S, Kirtane AJ, Thourani VH, Tuzcu EM, Svensson LG, Waksman R, Smith CR, Leon MB. Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery: an analysis of the PARTNER Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014 Mar 25;63(11):1090-9. doi: 10.1016/j.jacc.2013.10.057. Epub 2013 Nov 27.
- Elmariah S, Palacios IF, McAndrew T, Hueter I, Inglessis I, Baker JN, Kodali S, Leon MB, Svensson L, Pibarot P, Douglas PS, Fearon WF, Kirtane AJ, Maniar HS, Passeri JJ; PARTNER Investigators. Outcomes of transcatheter and surgical aortic valve replacement in high-risk patients with aortic stenosis and left ventricular dysfunction: results from the Placement of Aortic Transcatheter Valves (PARTNER) trial (cohort A). Circ Cardiovasc Interv. 2013 Dec;6(6):604-14. doi: 10.1161/CIRCINTERVENTIONS.113.000650. Epub 2013 Nov 12.
- Makkar RR, Jilaihawi H, Mack M, Chakravarty T, Cohen DJ, Cheng W, Fontana GP, Bavaria JE, Thourani VH, Herrmann HC, Pichard A, Kapadia S, Babaliaros V, Whisenant BK, Kodali SK, Williams M, Trento A, Smith CR, Teirstein PS, Cohen MG, Xu K, Tuzcu EM, Webb JG, Leon MB. Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons. J Am Coll Cardiol. 2014 Mar 11;63(9):901-11. doi: 10.1016/j.jacc.2013.08.1641. Epub 2013 Oct 23.
- Barbanti M, Webb JG, Hahn RT, Feldman T, Boone RH, Smith CR, Kodali S, Zajarias A, Thompson CR, Green P, Babaliaros V, Makkar RR, Szeto WY, Douglas PS, McAndrew T, Hueter I, Miller DC, Leon MB; Placement of Aortic Transcatheter Valve Trial Investigators. Impact of preoperative moderate/severe mitral regurgitation on 2-year outcome after transcatheter and surgical aortic valve replacement: insight from the Placement of Aortic Transcatheter Valve (PARTNER) Trial Cohort A. Circulation. 2013 Dec 24;128(25):2776-84. doi: 10.1161/CIRCULATIONAHA.113.003885. Epub 2013 Oct 23.
- Dvir D, Waksman R, Barbash IM, Kodali SK, Svensson LG, Tuzcu EM, Xu K, Minha S, Alu MC, Szeto WY, Thourani VH, Makkar R, Kapadia S, Satler LF, Webb JG, Leon MB, Pichard AD. Outcomes of patients with chronic lung disease and severe aortic stenosis treated with transcatheter versus surgical aortic valve replacement or standard therapy: insights from the PARTNER trial (placement of AoRTic TraNscathetER Valve). J Am Coll Cardiol. 2014 Jan 28;63(3):269-79. doi: 10.1016/j.jacc.2013.09.024. Epub 2013 Oct 16.
- Green P, Cohen DJ, Genereux P, McAndrew T, Arnold SV, Alu M, Beohar N, Rihal CS, Mack MJ, Kapadia S, Dvir D, Maurer MS, Williams MR, Kodali S, Leon MB, Kirtane AJ. Relation between six-minute walk test performance and outcomes after transcatheter aortic valve implantation (from the PARTNER trial). Am J Cardiol. 2013 Sep 1;112(5):700-6. doi: 10.1016/j.amjcard.2013.04.046. Epub 2013 May 29.
- Makkar RR, Jilaihawi H, Chakravarty T, Fontana GP, Kapadia S, Babaliaros V, Cheng W, Thourani VH, Bavaria J, Svensson L, Kodali S, Shiota T, Siegel R, Tuzcu EM, Xu K, Hahn RT, Herrmann HC, Reisman M, Whisenant B, Lim S, Beohar N, Mack M, Teirstein P, Rihal C, Douglas PS, Blackstone E, Pichard A, Webb JG, Leon MB. Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve). J Am Coll Cardiol. 2013 Jul 30;62(5):418-30. doi: 10.1016/j.jacc.2013.04.037. Epub 2013 May 15.
- Herrmann HC, Pibarot P, Hueter I, Gertz ZM, Stewart WJ, Kapadia S, Tuzcu EM, Babaliaros V, Thourani V, Szeto WY, Bavaria JE, Kodali S, Hahn RT, Williams M, Miller DC, Douglas PS, Leon MB. Predictors of mortality and outcomes of therapy in low-flow severe aortic stenosis: a Placement of Aortic Transcatheter Valves (PARTNER) trial analysis. Circulation. 2013 Jun 11;127(23):2316-26. doi: 10.1161/CIRCULATIONAHA.112.001290. Epub 2013 May 9.
- Hahn RT, Pibarot P, Stewart WJ, Weissman NJ, Gopalakrishnan D, Keane MG, Anwaruddin S, Wang Z, Bilsker M, Lindman BR, Herrmann HC, Kodali SK, Makkar R, Thourani VH, Svensson LG, Akin JJ, Anderson WN, Leon MB, Douglas PS. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (placement of aortic transcatheter valves). J Am Coll Cardiol. 2013 Jun 25;61(25):2514-21. doi: 10.1016/j.jacc.2013.02.087. Epub 2013 Apr 23.
- Reynolds MR, Magnuson EA, Lei Y, Wang K, Vilain K, Li H, Walczak J, Pinto DS, Thourani VH, Svensson LG, Mack MJ, Miller DC, Satler LE, Bavaria J, Smith CR, Leon MB, Cohen DJ; PARTNER Investigators. Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A). J Am Coll Cardiol. 2012 Dec 25;60(25):2683-92. doi: 10.1016/j.jacc.2012.09.018. Epub 2012 Nov 1.
- Green P, Woglom AE, Genereux P, Daneault B, Paradis JM, Schnell S, Hawkey M, Maurer MS, Kirtane AJ, Kodali S, Moses JW, Leon MB, Smith CR, Williams M. The impact of frailty status on survival after transcatheter aortic valve replacement in older adults with severe aortic stenosis: a single-center experience. JACC Cardiovasc Interv. 2012 Sep;5(9):974-81. doi: 10.1016/j.jcin.2012.06.011.
- Reynolds MR, Magnuson EA, Wang K, Thourani VH, Williams M, Zajarias A, Rihal CS, Brown DL, Smith CR, Leon MB, Cohen DJ; PARTNER Trial Investigators. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results from the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial (Cohort A). J Am Coll Cardiol. 2012 Aug 7;60(6):548-58. doi: 10.1016/j.jacc.2012.03.075. Epub 2012 Jul 18.
- Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.
- Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 May 3;366(18):1696-704. doi: 10.1056/NEJMoa1202277. Epub 2012 Mar 26. Erratum In: N Engl J Med. 2012 Aug 30;367(9):881.
- Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, Rajeswaran J, Anderson WN, Moses JW, Tuzcu EM, Webb JG, Leon MB, Smith CR; PARTNER Trial Investigators and Patients; PARTNER Stroke Substudy Writing Group and Executive Committee. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012 Apr;143(4):832-843.e13. doi: 10.1016/j.jtcvs.2012.01.055.
- Reynolds MR, Magnuson EA, Wang K, Lei Y, Vilain K, Walczak J, Kodali SK, Lasala JM, O'Neill WW, Davidson CJ, Smith CR, Leon MB, Cohen DJ; PARTNER Investigators. Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B). Circulation. 2012 Mar 6;125(9):1102-9. doi: 10.1161/CIRCULATIONAHA.111.054072. Epub 2012 Feb 3.
- Reynolds MR, Magnuson EA, Lei Y, Leon MB, Smith CR, Svensson LG, Webb JG, Babaliaros VC, Bowers BS, Fearon WF, Herrmann HC, Kapadia S, Kodali SK, Makkar RR, Pichard AD, Cohen DJ; Placement of Aortic Transcatheter Valves (PARTNER) Investigators. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011 Nov 1;124(18):1964-72. doi: 10.1161/CIRCULATIONAHA.111.040022. Epub 2011 Oct 3.
- Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
- Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. april 2007
Primær fullføring (Faktiske)
1. september 2010
Studiet fullført (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først innsendt
14. september 2007
Først innsendt som oppfylte QC-kriteriene
14. september 2007
Først lagt ut (Anslag)
18. september 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. september 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2006-06-US
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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