Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

Официальное название

Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство NVT ALLEGRA TAVI 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
• Устройство 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

Первичные конечные точки

• Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE). [Срок оценки: 30 days]

Вторичные конечные точки (8)

• Proportion of patients with device success after the Valve In Valve (VIV) procedure [Срок оценки: 30 days]
• Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure [Срок оценки: 30 days]
• Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention. [Срок оценки: 30 days]
• Early safety at 30 days as defined by Valve Academic Research Consortium 3 (VARC-3) criteria [Срок оценки: 30 days]
• Clinical efficacy at 1 year as defined by VARC-3 criteria [Срок оценки: 1 year]
• Trans-aortic mean gradient [Срок оценки: 1 year]
• Death [Срок оценки: 1 year]
• Stroke [Срок оценки: 1 year]

Критерии участия

Критерии включения

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.

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 6 центров

• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
• Hospital Clinico San Carlos — Madrid
• Hospital Universitario de La Paz — Madrid
• Hospital Universitario Puerta De Hierro — Majadahonda
• Hospital Clínico Universitario de Salamanca — Salamanca
• Hospital Universitari I Politècnic de La Fe — Valencia

Великобритания · 3 центра

• Manchester University NHS Foundation Trust — Manchester
• Freeman Hospital — Newcastle
• Morriston Hospital, Swansea — Swansea

Италия · 2 центра

• Azienda Ospedaliero- Universitaria di Alessandria — Alessandria
• Azienda Ospedaliera di Perugia — Perugia

Публикации

• 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 202 PMID 33890713
• 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. PMID 32445575
• 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, Veulema PMID 32592401
• 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. PMID 35597385
• 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. PMID 35393102
• 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. PMID 33478639
• 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, S PMID 33413929

Идентификаторы

NCT: NCT06049654 · EPIC34-VIVALL 2 TRIAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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