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

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ClinicalTrials.gov Identifier: NCT06049654
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Fundación EPIC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Structural Valve Deterioration Device: NVT ALLEGRA TAVI System TF Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Actual Study Start Date : February 1, 2024
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE). [ Time Frame: 30 days ]
    Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).


Secondary Outcome Measures :
  1. Proportion of patients with device success after the Valve In Valve (VIV) procedure [ Time Frame: 30 days ]
    Device success after the VIV procedure to the VARC-3 criteria

  2. Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure [ Time Frame: 30 days ]
    Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure

  3. Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention. [ Time Frame: 30 days ]
    Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention.

  4. Early safety at 30 days as defined by Valve Academic Research Consortium 3 (VARC-3) criteria [ Time Frame: 30 days ]
    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.

  5. Clinical efficacy at 1 year as defined by VARC-3 criteria [ Time Frame: 1 year ]
    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.

  6. Trans-aortic mean gradient [ Time Frame: 1 year ]
    Trans-aortic mean gradient 1 year after TAVR procedure

  7. Death [ Time Frame: 1 year ]
    Incidence of Death

  8. Stroke [ Time Frame: 1 year ]
    Incidence of Stroke


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049654


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

Locations
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Spain
Hospital Universitario de La Paz Recruiting
Madrid, Spain, 28046
Sponsors and Collaborators
Fundación EPIC
More Information
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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.
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.

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Responsible Party: Fundación EPIC
ClinicalTrials.gov Identifier: NCT06049654    
Other Study ID Numbers: EPIC34-VIVALL 2 TRIAL
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación EPIC:
Valve-In-Valve
Aortic stenosis
Aortic regurgitation
Trans-catheter aortic valve
Degenerated aortic valve
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Fexofenadine
Anti-Allergic Agents
 Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs