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RecruitingNCT06049654Updated Sep 24, 2026

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

An interventional study of NVT ALLEGRA TAVI System TF and EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM in Aortic Valve Stenosis and Structural Valve Deterioration, sponsored by Fundación EPIC. Recruiting at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Fundación EPIC · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Aortic Valve Stenosis
  • Structural Valve Deterioration

Keywords

  • Valve-In-Valve
  • Aortic stenosis
  • Aortic regurgitation
  • Trans-catheter aortic valve
  • Degenerated aortic valve
03

In context

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 104 is below the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Fundación EPIC is the lead sponsor of 48 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 or 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 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).
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Active comparator
    NVT ALLEGRA System TF

    NVT ALLEGRA System TF

    Device: NVT ALLEGRA TAVI System TF

  • Experimental
    EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

    EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

    Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Interventions

  • DeviceNVT 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

  • DeviceEDWARDS 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

06

What researchers measure

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).

    Time frame: 30 days

Secondary outcomes

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

    Device success after the VIV procedure to the VARC-3 criteria

    Time frame: 30 days

  2. 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

    Time frame: 30 days

  3. 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.

    Time frame: 30 days

  4. 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.

    Time frame: 30 days

  5. 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.

    Time frame: 1 year

  6. Trans-aortic mean gradient

    Trans-aortic mean gradient 1 year after TAVR procedure

    Time frame: 1 year

  7. Death

    Incidence of Death

    Time frame: 1 year

  8. Stroke

    Incidence of Stroke

    Time frame: 1 year

07

Study locations

12 of 12 sites recruiting
08

References and documents

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 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. PubMed 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, 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 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. Epub 2022 May 18. PubMed 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. PubMed 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. PubMed 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, 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Nov 2027, 45 months after the start.

Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 45 months is close to that.

Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2023
First posted
Sep 22, 2023
StartActual
Feb 1, 2024
Primary completionEst.
Nov 1, 2027
CompletionEst.
Nov 1, 2027
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06049654
Lead sponsor
Fundación EPIC
Responsible party
Sponsor
First posted
Sep 22, 2023
Start date
Feb 1, 2024
Primary completion
Nov 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

RAÚL MORENO GÓMEZ, MD, PhD
Contact
raulmorenog@hotmail.com
0034917277000
FUNDACION EPIC
Contact
iepic@fundacionepic.org
0034987876135

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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