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

NCT06049654 | Recruiting DMC

• 1 other identifier: EPIC34-VIVALL 2 TRIAL
• Study Type: interventional
• Target: 104
• Locations: 2 countries
• Sites: 9

Brief Summary

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.

Conditions

Aortic Valve Stenosis; Structural Valve Deterioration

Keywords

Valve-In-Valve; Aortic stenosis; Aortic regurgitation; Trans-catheter aortic valve; Degenerated aortic valve

Outcome Measures

Primary Outcomes (1)

• Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).

  Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).

  30 days

Secondary Outcomes (8)

• Proportion of patients with device success after the Valve In Valve (VIV) procedure

  30 days

• Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure

  30 days

• Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention.

  30 days

• Early safety at 30 days as defined by Valve Academic Research Consortium 3 (VARC-3) criteria

  30 days

• Clinical efficacy at 1 year as defined by VARC-3 criteria

  1 year

Study Arms (2)

NVT ALLEGRA System TF

ACTIVE COMPARATOR

NVT ALLEGRA System TF

Device: NVT ALLEGRA TAVI System TF

EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

EXPERIMENTAL

EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Interventions

NVT ALLEGRA TAVI System TF DEVICE

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

NVT ALLEGRA System TF

EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM DEVICE

Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically

EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (9)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario de La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Universitario Puerta De Hierro

Majadahonda, 28222, Spain

RECRUITING

Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Hospital Universitari I Politècnic de La Fe

Valencia, 46026, Spain

RECRUITING

Manchester University NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

Freeman Hospital

Newcastle, United Kingdom

RECRUITING

Morriston Hospital, Swansea

Swansea, United Kingdom

RECRUITING

Related Publications (7)

• 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.

  PMID: 33890713 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 32592401 BACKGROUND

• 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.

  PMID: 35597385 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 33413929 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

RAÚL MORENO GÓMEZ, MD, PhD

CONTACT

0034917277000; raulmorenog@hotmail.com

FUNDACION EPIC

CONTACT

0034987876135; iepic@fundacionepic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 22, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

ES (6); GB (3)