Vergelijking van Allegra versus Sapien Transkatheter-aortakleppen bij Valve-In-Valve-indicatie
Klinisch onderzoek naar de resultaten van Allegra versus Sapien transkatheter-aortakleppen bij klep-in-klep-indicatie
The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
In the VIVALL.2 study, 104 patients with severely degenerated biological aortic surgical valve accepted for vave-in-valve procedure (transcatheter aortic valve implantation) will be randomized to be treated with the self-expandable supra-annular Allegra or the balloon-expandable intra-annular Edwards systems. The primary end-point will be trans-aortic mean gradient determined by trans-thoracic echocardiography at 30 days. The proportion of patients with moderate or severe prosthesis mismatch at 30 days will be a secondary end-.point. Different countries will participate in the study.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: FUNDACION EPIC
- Telefoonnummer: 0034987876135
- E-mail: iepic@fundacionepic.org
Studie Contact Back-up
- Naam: RAÚL MORENO GÓMEZ, MD, PhD
- Telefoonnummer: 0034917277000
- E-mail: raulmorenog@hotmail.com
Studie Locaties
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Alessandria, Italië
- Werving
- Azienda Ospedaliero- Universitaria di Alessandria
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Brescia, Italië, 25123
- Werving
- ASST Spedali Civili di Brescia
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Perugia, Italië
- Werving
- Azienda Ospedaliera di Perugia
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L'Hospitalet de Llobregat, Spanje, 08907
- Werving
- Hospital Universitari de Bellvitge
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Madrid, Spanje, 28040
- Werving
- Hospital Clinico San Carlos
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Madrid, Spanje, 28046
- Werving
- Hospital Universitario de La Paz
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Majadahonda, Spanje, 28222
- Werving
- Hospital Universitario Puerta De Hierro
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Salamanca, Spanje, 37007
- Werving
- Hospital Clínico Universitario de Salamanca
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Valencia, Spanje, 46026
- Werving
- Hospital Universitari I Politècnic de La Fe
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Manchester, Verenigd Koninkrijk
- Werving
- Manchester University NHS Foundation Trust
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Newcastle, Verenigd Koninkrijk
- Werving
- Freeman Hospital
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Swansea, Verenigd Koninkrijk
- Werving
- Morriston Hospital, Swansea
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Patients meeting ALL the following criteria will be included:
- Patients aged ≥ 18 years.
- Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area < 1.0 cm2) and/or severe valve regurgitation.
- The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease.
- Heart team decision of VIV procedure.
- Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year.
Exclusion Criteria:
Patients meeting, at least, 1 of the following criteria will be excluded:
- Patients who openly express their refusal to participate in the study.
- Female patients in gestational age.
- Presence or suspicious of biological aortic valve thrombosis.
- Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
- Ongoing sepsis and/or suspicious or diagnosis of endocarditis.
- Patients whose life expectancy is < 1 year due to non-cardiac comorbid conditions.
- Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams.
- True inner diameter of the prosthetic valve > 27 mm.
- Transfemoral access inadequate to accommodate an 18F sheath.
- Patients included in other clinical trials (excluding registries).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: NVT ALLEGRA System TF
NVT ALLEGRA System TF |
Transcatheter aortic valve implantation of a NVT ALLEGRA TAVI System TF in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically |
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Experimenteel: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM |
Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).
Tijdsspanne: 30 days
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Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE). |
30 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Proportion of patients with device success after the Valve In Valve (VIV) procedure
Tijdsspanne: 30 days
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Device success after the VIV procedure to the VARC-3 criteria |
30 days
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Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure
Tijdsspanne: 30 days
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Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure |
30 days
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Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention.
Tijdsspanne: 30 days
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Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention. |
30 days
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Early safety at 30 days as defined by Valve Academic Research Consortium 3 (VARC-3) criteria
Tijdsspanne: 30 days
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freedom from: all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device. |
30 days
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Clinical efficacy at 1 year as defined by VARC-3 criteria
Tijdsspanne: 1 year
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freedom from: all-cause mortality, all stroke, hospitalization for procedure- or valve related causes, KCCQ Overall Summary Score <45 or decline from baseline of >10 point. |
1 year
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Trans-aortic mean gradient
Tijdsspanne: 1 year
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Trans-aortic mean gradient 1 year after TAVR procedure |
1 year
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Death
Tijdsspanne: 1 year
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Incidence of Death |
1 year
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Stroke
Tijdsspanne: 1 year
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Incidence of Stroke |
1 year
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Bleiziffer S, Simonato M, Webb JG, Rodes-Cabau J, Pibarot P, Kornowski R, Windecker S, Erlebach M, Duncan A, Seiffert M, Unbehaun A, Frerker C, Conzelmann L, Wijeysundera H, Kim WK, Montorfano M, Latib A, Tchetche D, Allali A, Abdel-Wahab M, Orvin K, Stortecky S, Nissen H, Holzamer A, Urena M, Testa L, Agrifoglio M, Whisenant B, Sathananthan J, Napodano M, Landi A, Fiorina C, Zittermann A, Veulemans V, Sinning JM, Saia F, Brecker S, Presbitero P, De Backer O, Sondergaard L, Bruschi G, Franco LN, Petronio AS, Barbanti M, Cerillo A, Spargias K, Schofer J, Cohen M, Munoz-Garcia A, Finkelstein A, Adam M, Serra V, Teles RC, Champagnac D, Iadanza A, Chodor P, Eggebrecht H, Welsh R, Caixeta A, Salizzoni S, Dager A, Auffret V, Cheema A, Ubben T, Ancona M, Rudolph T, Gummert J, Tseng E, Noble S, Bunc M, Roberts D, Kass M, Gupta A, Leon MB, Dvir D. Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves. Eur Heart J. 2020 Aug 1;41(29):2731-2742. doi: 10.1093/eurheartj/ehaa544.
- Moreno R, Baz JA, Moreu J, Berenguer A, Gonzalvez-Garcia A, Galeote G, Hernandez U, Canton T, Jimenez-Valero S, Jurado-Roman A, Moya H, Lazaro E. Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra-annular device. The Spanish Allegra valve-in-valve (SAVIV) registry. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):365-370. doi: 10.1002/ccd.29742. Epub 2021 Apr 23.
- Hirji SA, Percy ED, Zogg CK, Malarczyk A, Harloff MT, Yazdchi F, Kaneko T. Comparison of in-hospital outcomes and readmissions for valve-in-valve transcatheter aortic valve replacement vs. reoperative surgical aortic valve replacement: a contemporary assessment of real-world outcomes. Eur Heart J. 2020 Aug 1;41(29):2747-2755. doi: 10.1093/eurheartj/ehaa252.
- Hahn RT, Webb J, Pibarot P, Ternacle J, Herrmann HC, Suri RM, Dvir D, Leipsic J, Blanke P, Jaber WA, Kodali S, Kapadia S, Makkar R, Thourani V, Williams M, Salaun E, Vincent F, Xu K, Leon MB, Mack M. 5-Year Follow-Up From the PARTNER 2 Aortic Valve-in-Valve Registry for Degenerated Aortic Surgical Bioprostheses. JACC Cardiovasc Interv. 2022 Apr 11;15(7):698-708. doi: 10.1016/j.jcin.2022.02.014.
- Landes U, Sathananthan J, Witberg G, De Backer O, Sondergaard L, Abdel-Wahab M, Holzhey D, Kim WK, Hamm C, Buzzatti N, Montorfano M, Ludwig S, Conradi L, Seiffert M, Guerrero M, El Sabbagh A, Rodes-Cabau J, Guimaraes L, Codner P, Okuno T, Pilgrim T, Fiorina C, Colombo A, Mangieri A, Eltchaninoff H, Nombela-Franco L, Van Wiechen MPH, Van Mieghem NM, Tchetche D, Schoels WH, Kullmer M, Tamburino C, Sinning JM, Al-Kassou B, Perlman GY, Danenberg H, Ielasi A, Fraccaro C, Tarantini G, De Marco F, Redwood SR, Lisko JC, Babaliaros VC, Laine M, Nerla R, Castriota F, Finkelstein A, Loewenstein I, Eitan A, Jaffe R, Ruile P, Neumann FJ, Piazza N, Alosaimi H, Sievert H, Sievert K, Russo M, Andreas M, Bunc M, Latib A, Godfrey R, Hildick-Smith D, Chuang MA, Blanke P, Leipsic J, Wood DA, Nazif TM, Kodali S, Barbanti M, Kornowski R, Leon MB, Webb JG. Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses. J Am Coll Cardiol. 2021 Jan 5;77(1):1-14. doi: 10.1016/j.jacc.2020.10.053.
- Rodes-Cabau J, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Panagides V, Pelletier-Beaumont E, Pibarot P. Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses. J Am Coll Cardiol. 2022 Aug 16;80(7):681-693. doi: 10.1016/j.jacc.2022.05.005. Epub 2022 May 18.
- Sa MPBO, Van den Eynde J, Simonato M, Cavalcanti LRP, Doulamis IP, Weixler V, Kampaktsis PN, Gallo M, Laforgia PL, Zhigalov K, Ruhparwar A, Weymann A, Pibarot P, Clavel MA. Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement: An Updated Meta-Analysis. JACC Cardiovasc Interv. 2021 Jan 25;14(2):211-220. doi: 10.1016/j.jcin.2020.10.020.
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EPIC34-VIVALL 2 TRIAL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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