- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05847751
Brugen af ACURATE Neo 2-ventil hos patienter med symptomatisk aortaklapstenose i Mellemøsten (BSC07)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MENA-TAVI-studiet er et investigator-initieret, prospektivt, enkeltarms observationsforsøg.
Patienter, der henvises til eller præsenterer sig med svær aortastenose, der kræver en intervention, udgør kildepopulationen. Hjerteteamet bestående af interventionelle kardiologer og kardiovaskulære kirurger vil evaluere patienterne ved at integrere de tilgængelige kliniske data, den forudsagte 30-dages dødelighed, individuelle faktorer, der påvirker dødeligheden såsom skrøbelighed samt den estimerede levetid og patientens ønsker til endelig at nå en konsensus om den optimale behandlingsstrategi med hensyn til transkateter eller kirurgisk aortaklapudskiftning. Patienter, der er planlagt til TAVI, vil blive screenet for berettigelse. Hvis patienter opfylder al inklusion og ikke opfylder eksklusionskriterier, vil de blive informeret om undersøgelsens formål og forløb og vil blive bedt om deltagelse og skriftligt informeret samtykke. I tilfælde af samtykke vil de blive behandlet af ACURATE neo2 aortabioprotesen.
Ved udskrivelse og efter 30 dage vil de kliniske resultater, der udgør det primære sikkerhedsendepunkt, blive registreret. Yderligere kliniske, proceduremæssige og ekkokardiografiske data vil blive indhentet ved udskrivelse og efter 30 dage til vurdering af sekundære endepunkter.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Christophe LE ROUX, MSc
- Telefonnummer: +33 (0)7 60 27 80 98
- E-mail: cleroux@cerc-europe.org
Undersøgelse Kontakt Backup
- Navn: Phani KONDAMUDI, PhD
- Telefonnummer: +33 (0)1 76 73 92 52
- E-mail: pkondamudi@cerc-europe.org
Studiesteder
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Aswan, Egypten
- Magdy Yacoub heart center
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Kontakt:
- Ahmed Elguindy, MD
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Cairo, Egypten
- Ain Shams Specialized Hospital
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Kontakt:
- Ahmed El Sayed, MD
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Cairo, Egypten
- Badr hospital
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Kontakt:
- Yasser Sadek, MD
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Beirut, Libanon
- American University of Beirut
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Kontakt:
- fadi Sawaya, MD
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Jeddah, Saudi Arabien
- King Fahad Armed Forces Hospital
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Kontakt:
- Khaled Al Shaibi
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Riyadh, Saudi Arabien
- King Fahad National Guard Hospital
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Kontakt:
- Mohammed BALGHITH, MD
- Telefonnummer: +966504147204
- E-mail: mbalghith@hotmail.com
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Riyadh, Saudi Arabien
- National Guard Hospital - King Abdulaziz Medical City
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Kontakt:
- Wail Alkashkari, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
Emnet vil blive inkluderet, hvis alle følgende kriterier er opfyldt:
- Patient med svær aortastenose defineret ved et aortaklapareal (AVA) < 1 cm2 eller AVA indekseret til kropsoverfladeareal (BSA) på < 0,6 cm2/m2, inklusive lav-flow svær aortastenose defineret ved slagvolumenindeks (SVI) < 35 ml /m2, vurderet ved integration af ekkokardiografiske og invasive målinger
- Personen er symptomatisk (symptomer på hjertesvigt med New York Heart Association (NYHA) Funktionsklasse > I, angina eller synkope)
- Patienten anses for høj (STS-PROM (Society of Thoracic Surgeons-Predicted Risk of Mortality) score >8) eller mellemliggende (STS-PROM score >4) af hjerteteamet.
- Hjerteteamet er enige om patientens berettigelse til deltagelse, og at TAVR (Transcatheter aortic valve replacement) (TAVR) ved transfemoral adgang udgør den mest passende behandlingsmodalitet, som patienten sandsynligvis vil have størst gavn af.
- Aorta ringformede dimensioner egnede (arealområde: 338-573 mm2 OG perimeterområde: 66-85 mm) baseret på EKG-gatede multislice computertomografiske målinger. Fund af transesophageal ekkokardiografi (TEE) og konventionel aortografi bør integreres i den anatomiske vurdering, hvis de er tilgængelige
- Arteriel aorto-iliaca-femoral akse egnet til transfemoral adgang med en minimum adgangskardiameter ≥ 6 mm vurderet ved multislice computertomografisk angiografi og/eller konventionel angiografi
- Skriftligt informeret samtykke fra patienten eller hendes/hans juridiske repræsentant
- Patienten forstår formålet, de potentielle risici samt fordelene ved forsøget og er villig til at deltage i alle dele af opfølgningen
Ekskluderingskriterier:
Emnet vil ikke blive inkluderet, hvis en af følgende betingelser eksisterer:
- Ikke-valvulær aortastenose
- Medfødt aortastenose eller unicuspid eller bicuspid aortaklap
- Ikke-kalkisk erhvervet aortastenose
- Anatomi ikke egnet til transfemoral transkateter aortaklapimplantation på grund af størrelsen af aorta-annulus eller graden eller excentriciteten af forkalkning af den native aortaklap eller snoethed af aorta eller ilio-femoral arterier
- Nødprocedure inklusive patienter i kardiogent shock (lavt hjertevolumen, vasopressorafhængighed, mekanisk hæmodynamisk støtte)
- Alvorligt nedsat venstre ventrikulær (LV) funktion (ejektionsfraktion < 20 %)
- Eksisterende hjerteklapprotese i aortaposition
- Tilstedeværelse af mitralklapprotese
- Samtidig planlagt procedure undtagen perkutan koronar intervention (PCI)
- Planlagt ikke-hjerteoperation inden for 30 dage
- Slagtilfælde inden for 30 dage efter proceduren.
- Myokardieinfarkt inden for 30 dage efter proceduren (undtagen type 2)
- Bevis på intra-kardial masse, trombe eller vegetation
- Alvorlige koagulationsforhold
- Manglende evne til at tolerere antikoagulation/anti-blodpladebehandling
- Aktiv bakteriel endocarditis eller andre aktive infektioner
- Hypertrofisk kardiomyopati
- Kontraindikation til kontrastmidler eller allergi over for nitinol
- Deltagelse i et andet forsøg, som ville føre til afvigelser i forberedelsen eller udførelsen af interventionen eller post-implantationsstyringen fra denne protokol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Alle forårsager dødelighed
Tidsramme: Udskrivning efter proceduren af patienten fra hospitalet (helst 1-3 dage efter proceduren)
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Alle dødsfald rapporteret
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Udskrivning efter proceduren af patienten fra hospitalet (helst 1-3 dage efter proceduren)
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Ethvert slagtilfælde (invaliderende og ikke-invaliderende)
Tidsramme: Udskrivning efter proceduren af patienten fra hospitalet (helst 1-3 dage efter proceduren)
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Alle slagtilfælde
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Udskrivning efter proceduren af patienten fra hospitalet (helst 1-3 dage efter proceduren)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Teknisk succes som defineret af VARC-3
Tidsramme: Udskrivning efter proceduren af patienten fra hospitalet (helst 1-3 dage efter proceduren)
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Kombineret endepunkt sammensat af:
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Udskrivning efter proceduren af patienten fra hospitalet (helst 1-3 dage efter proceduren)
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Enhedssucces som defineret af VARC-3
Tidsramme: Post-procedure udskrivning af patient fra hospitalet og efter 30 dages opfølgning
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Kombineret endepunkt sammensat af:
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Post-procedure udskrivning af patient fra hospitalet og efter 30 dages opfølgning
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Tidlig sikkerhed som defineret af VARC-3
Tidsramme: Ved 30 dage
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Kombineret endepunkt sammensat af:
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Ved 30 dage
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Modificeret kombineret tidlig sikkerhed og klinisk effekt efter 30 dage som defineret af Valve Academic Research Consortium (VARC-2)
Tidsramme: Ved 30 dage
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Ved 30 dage
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Klinisk effekt som defineret af VARC-3
Tidsramme: Ved 30 dage
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Kombineret endepunkt sammensat af:
Kombineret endepunkt sammensat af:
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Ved 30 dage
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Dødelighed af alle årsager
Tidsramme: Ved 30 dage
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Alle dødsfald rapporteret
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Ved 30 dage
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Ventilrelateret dødelighed
Tidsramme: Ved 30 dage
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Alle dødsfald relateret til ventil
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Ved 30 dage
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Alle slagtilfælde (iskæmisk, hæmoragisk)
Tidsramme: Ved 30 dage
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Alle slagtilfælde rapporteret
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Ved 30 dage
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Hospitalsindlæggelse (eller genindlæggelse)
Tidsramme: Ved 30 dage
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Alle indlæggelser rapporteret
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Ved 30 dage
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Blødning og transfusioner (VARC3 type 1 - 4)
Tidsramme: Ved 30 dage
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Alle blødningshændelser rapporteret
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Ved 30 dage
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Dysfunktion af bioproteseklap
Tidsramme: Ved 30 dage
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(strukturel, ikke-strukturel, trombose, endocarditis): (stadie 1 til 3)
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Ved 30 dage
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Klinisk signifikant proteseklap-trombose
Tidsramme: Ved 30 dage
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Ventilrelateret trombose
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Ved 30 dage
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Implantation af permanent pacemaker
Tidsramme: Ved 30 dage
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Pacemakerimplantation
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Ved 30 dage
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Forekomst af atrieflimren
Tidsramme: Ved 30 dage
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atrieflimren rapporteret
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Ved 30 dage
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mohamed BALGHITH, MD, King Fahad National Guard Hospital
Publikationer og nyttige links
Generelle publikationer
- Brown JM, O'Brien SM, Wu C, Sikora JA, Griffith BP, Gammie JS. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg. 2009 Jan;137(1):82-90. doi: 10.1016/j.jtcvs.2008.08.015.
- Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
- Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7. doi: 10.1056/NEJM199907153410302.
- 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.
- 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.
- Thanassoulis G, Campbell CY, Owens DS, Smith JG, Smith AV, Peloso GM, Kerr KF, Pechlivanis S, Budoff MJ, Harris TB, Malhotra R, O'Brien KD, Kamstrup PR, Nordestgaard BG, Tybjaerg-Hansen A, Allison MA, Aspelund T, Criqui MH, Heckbert SR, Hwang SJ, Liu Y, Sjogren M, van der Pals J, Kalsch H, Muhleisen TW, Nothen MM, Cupples LA, Caslake M, Di Angelantonio E, Danesh J, Rotter JI, Sigurdsson S, Wong Q, Erbel R, Kathiresan S, Melander O, Gudnason V, O'Donnell CJ, Post WS; CHARGE Extracoronary Calcium Working Group. Genetic associations with valvular calcification and aortic stenosis. N Engl J Med. 2013 Feb 7;368(6):503-12. doi: 10.1056/NEJMoa1109034.
- Rossebo AB, Pedersen TR, Boman K, Brudi P, Chambers JB, Egstrup K, Gerdts E, Gohlke-Barwolf C, Holme I, Kesaniemi YA, Malbecq W, Nienaber CA, Ray S, Skjaerpe T, Wachtell K, Willenheimer R; SEAS Investigators. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med. 2008 Sep 25;359(13):1343-56. doi: 10.1056/NEJMoa0804602. Epub 2008 Sep 2.
- Chakos A, Wilson-Smith A, Arora S, Nguyen TC, Dhoble A, Tarantini G, Thielmann M, Vavalle JP, Wendt D, Yan TD, Tian DH. Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond. Ann Cardiothorac Surg. 2017 Sep;6(5):432-443. doi: 10.21037/acs.2017.09.10.
- 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.
- Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.
- Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9.
- Manoharan G, Walton AS, Brecker SJ, Pasupati S, Blackman DJ, Qiao H, Meredith IT. Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1359-1367. doi: 10.1016/j.jcin.2015.05.015.
- Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.
- Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27.
- Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
- Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
- Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
- Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.
- Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
- Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
- Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.
- VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
- Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693.
- Iung B, Vahanian A. Degenerative calcific aortic stenosis: a natural history. Heart. 2012 Nov;98 Suppl 4:iv7-13. doi: 10.1136/heartjnl-2012-302395.
- Otto CM, Prendergast B. Aortic-valve stenosis--from patients at risk to severe valve obstruction. N Engl J Med. 2014 Aug 21;371(8):744-56. doi: 10.1056/NEJMra1313875. No abstract available.
- Tibazarwa KB, Volmink JA, Mayosi BM. Incidence of acute rheumatic fever in the world: a systematic review of population-based studies. Heart. 2008 Dec;94(12):1534-40. doi: 10.1136/hrt.2007.141309. Epub 2008 Jul 31.
- Otto CM. Calcific aortic stenosis--time to look more closely at the valve. N Engl J Med. 2008 Sep 25;359(13):1395-8. doi: 10.1056/NEJMe0807001. No abstract available.
- Katz R, Wong ND, Kronmal R, Takasu J, Shavelle DM, Probstfield JL, Bertoni AG, Budoff MJ, O'Brien KD. Features of the metabolic syndrome and diabetes mellitus as predictors of aortic valve calcification in the Multi-Ethnic Study of Atherosclerosis. Circulation. 2006 May 2;113(17):2113-9. doi: 10.1161/CIRCULATIONAHA.105.598086. Epub 2006 Apr 24.
- Owens DS, Katz R, Takasu J, Kronmal R, Budoff MJ, O'Brien KD. Incidence and progression of aortic valve calcium in the Multi-ethnic Study of Atherosclerosis (MESA). Am J Cardiol. 2010 Mar 1;105(5):701-8. doi: 10.1016/j.amjcard.2009.10.071.
- Rosenhek R, Zilberszac R, Schemper M, Czerny M, Mundigler G, Graf S, Bergler-Klein J, Grimm M, Gabriel H, Maurer G. Natural history of very severe aortic stenosis. Circulation. 2010 Jan 5;121(1):151-6. doi: 10.1161/CIRCULATIONAHA.109.894170. Epub 2009 Dec 21.
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