The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B (PARTNERII B)
27. august 2018 oppdatert av: Edwards Lifesciences
The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable).
Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.
Studietype
Intervensjonell
Registrering (Faktiske)
560
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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Arkansas
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Little Rock, Arkansas, Forente stater, 72211
- Arkansas Heart Hospital/Clinic
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California
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La Jolla, California, Forente stater, 92037
- Scripps Green Hospital
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La Jolla, California, Forente stater, 92037
- Scripps Memorial Hospital
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Los Angeles, California, Forente stater, 90048
- Cedars-Sinai Medical Center
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Sacramento, California, Forente stater, 95816
- Mercy General Hospital
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Stanford, California, Forente stater, 94305
- Stanford University Medical Center
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Colorado
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Denver, Colorado, Forente stater, 80045
- University Of Colorado Hospital
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District of Columbia
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Washington, District of Columbia, Forente stater, 20010
- Washington Hospital Center (WHC)
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Florida
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Clearwater, Florida, Forente stater, 33756
- Morton Plant Hospital
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Gainesville, Florida, Forente stater, 32610
- University of Florida, Gainesville
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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, 30308
- Emory University Hospital
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forente stater, 60611
- Northwestern Hospital
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Springfield, Illinois, Forente stater, 62701
- Prairie Education And Research Cooperative
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Indiana University Health-Methodist Hospital
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- The University of Iowa
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- University of Louisville - Jewish Hospital
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Louisiana
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New Orleans, Louisiana, Forente stater, 70121
- Ochsner Clinic Foundation
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
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Royal Oak, Michigan, Forente stater, 48073
- William Beaumont Hospital
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55407
- Minneapolis Heart Institute Foundation
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- Saint Luke's Hospital of Kansas City Mid America
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Saint Louis, Missouri, Forente stater, 63110
- Washington University - Barnes Jewish Hospital
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Nebraska
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Lincoln, Nebraska, Forente stater, 68526
- Nebraska Heart Institute
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Newark, New Jersey, Forente stater, 07112
- Newark Beth Israel
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New York
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Manhasset, New York, Forente stater, 11030
- North Shore University Hospital, NY
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Mineola, New York, Forente stater, 11501
- Winthrop University Hospital
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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
- Cornell University
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North Carolina
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Charleston, North Carolina, Forente stater, 29425
- Medical University of South Carolina Charleston
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Greenville, North Carolina, Forente stater, 27834
- East Carolina Heart Institute at East Carolina University
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- The Christ Hospital, Cincinnati
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Foundation
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73135
- Oklahoma Heart Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania Hospital
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York, Pennsylvania, Forente stater, 17403
- York Hospital
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Tennessee
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Memphis, Tennessee, Forente stater, 38120
- Baptist Memorial Hospital
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Texas
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Austin, Texas, Forente stater, 78756
- Austin Heart, PLLC
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Dallas, Texas, Forente stater, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Forente stater, 75093
- The Heart Hospital Baylor Plano
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Houston, Texas, Forente stater, 77030
- The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
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San Antonio, Texas, Forente stater, 78229-3900
- University of Texas Health Science Center at San Antonio (UTHSCSA)
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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, 22904
- University of Virginia
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Norfolk, Virginia, Forente stater, 23507
- Sentara Norfolk General Hospital
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Washington
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Seattle, Washington, Forente stater, 98195
- University of Washington
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin - Madison
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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
19 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria
- Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
- The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
- The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up.
Exclusion Criteria
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
- Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)
- Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
- Active bacterial endocarditis within 6 months (180 days) of procedure.
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: TAVR - SAPIEN XT
TAVR (transaortic valve replacement) with SAPIEN XT
|
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
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Aktiv komparator: TAVR - SAPIEN
TAVR (transaortic valve replacement) with SAPIEN is the control arm
|
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization
Tidsramme: 1 Year
|
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
|
1 Year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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NYHA Classification - Change From Baseline
Tidsramme: Baseline and 1 Year
|
New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity.
The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
|
Baseline and 1 Year
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Total Aortic Regurgitation - Change From Baseline
Tidsramme: 1 Year
|
Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe. Total regurgitation at one year was analyzed in the valve implant population. |
1 Year
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Effective Orifice Area - Change From Baseline
Tidsramme: 1 Year
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1 Year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Martin B Leon, MD, Columbia University
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
- Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.
- 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.
- Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.
- Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.
- 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.
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)
9. mars 2011
Primær fullføring (Faktiske)
1. mai 2013
Studiet fullført (Faktiske)
30. mai 2017
Datoer for studieregistrering
Først innsendt
17. januar 2014
Først innsendt som oppfylte QC-kriteriene
8. juli 2014
Først lagt ut (Anslag)
9. juli 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. september 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2010-12-PIIB
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
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. .