Aortic Valve StenosisNCT06049654
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
A study testing NVT ALLEGRA TAVI System TF and EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM in people with Aortic Valve Stenosis and Structural Valve Deterioration, run by Fundación EPIC at 12 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Structural Valve Deterioration
- What is being tested?
- NVT ALLEGRA TAVI System TF and EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 1 Feb 2024to 1 Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 3 countries
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
- Recruiting
Hospital Universitario de La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Puerta De Hierro
Majadahonda, 28222
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitari I Politècnic de La Fe
Valencia, 46026
Italy3 sites, 3 recruiting
- Recruiting
Azienda Ospedaliero- Universitaria di Alessandria
Alessandria
- Recruiting
ASST Spedali Civili di Brescia
Brescia, 25123
- Recruiting
Azienda Ospedaliera di Perugia
Perugia
United Kingdom3 sites, 3 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester
- Recruiting
Freeman Hospital
Newcastle
- Recruiting
Morriston Hospital, Swansea
Swansea
About this study
Official title: 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.
Read the 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.
- Being tested
- NVT ALLEGRA TAVI System TF, EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
- Keywords
- Valve-In-Valve, Aortic stenosis, Aortic regurgitation, Trans-catheter aortic valve, Degenerated aortic valve
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVT ALLEGRA TAVI System TFDevice
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
EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEMDevice
Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
| Study group | Role | What they receive |
|---|---|---|
| NVT ALLEGRA System TF | Active comparator | NVT ALLEGRA System TF Receives: Device: NVT ALLEGRA TAVI System TF |
| EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM | Experimental | EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM Receives: Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Secondary outcomes (8)
Proportion of patients with device success after the Valve In Valve (VIV) procedure
Device success after the VIV procedure to the VARC-3 criteria
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Trans-aortic mean gradient
Trans-aortic mean gradient 1 year after TAVR procedure
Measured: 1 year
Death
Incidence of Death
Measured: 1 year
Stroke
Incidence of Stroke
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Feb 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049654
- Sponsor's protocol ID
- EPIC34-VIVALL 2 TRIAL
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33890713Hirji 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.
PubMed 32445575Bleiziffer 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.
PubMed 32592401Rodes-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.
PubMed 35597385Hahn 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.
PubMed 35393102Sa 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.
PubMed 33478639Landes 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.
PubMed 33413929