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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Structural Valve Deterioration
• Intervention / Treatment: Device: NVT ALLEGRA TAVI System TF; Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: 0034987876135; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: RAÚL MORENO GÓMEZ, MD, PhD; Phone Number: 0034917277000; Email: raulmorenog@hotmail.com

Study Locations

• Italy
  • Alessandria, Italy
    • Recruiting
    • Azienda Ospedaliero- Universitaria di Alessandria
  • Brescia, Italy, 25123
    • Recruiting
    • ASST Spedali Civili di Brescia
  • Perugia, Italy
    • Recruiting
    • Azienda Ospedaliera di Perugia
• Spain
  • L'Hospitalet de Llobregat, Spain, 08907
    • Recruiting
    • Hospital Universitari de Bellvitge
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario de La Paz
  • Majadahonda, Spain, 28222
    • Recruiting
    • Hospital Universitario Puerta De Hierro
  • Salamanca, Spain, 37007
    • Recruiting
    • Hospital Clínico Universitario de Salamanca
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitari I Politècnic de La Fe
• United Kingdom
  • Manchester, United Kingdom
    • Recruiting
    • Manchester University NHS Foundation Trust
  • Newcastle, United Kingdom
    • Recruiting
    • Freeman Hospital
  • Swansea, United Kingdom
    • Recruiting
    • Morriston Hospital, Swansea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NVT ALLEGRA System TF; NVT ALLEGRA System TF	Device: 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
Experimental: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM; EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with device success after the Valve In Valve (VIV) procedure	Device success after the VIV procedure to the VARC-3 criteria	30 days
Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure	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.	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	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
Clinical efficacy at 1 year as defined by VARC-3 criteria	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
Trans-aortic mean gradient	Trans-aortic mean gradient 1 year after TAVR procedure	1 year
Death	Incidence of Death	1 year
Stroke	Incidence of Stroke	1 year

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: September 17, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 24, 2026
• Last Update Submitted That Met QC Criteria: September 23, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Aortic stenosis; Aortic regurgitation; Valve-In-Valve; Trans-catheter aortic valve; Degenerated aortic valve
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: EPIC34-VIVALL 2 TRIAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No