search
Back to results

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

Primary Purpose

Aortic Valve Stenosis, Structural Valve Deterioration

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NVT ALLEGRA TAVI System TF
EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
Sponsored by
Fundación EPIC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Valve-In-Valve, Aortic stenosis, Aortic regurgitation, Trans-catheter aortic valve, Degenerated aortic valve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    NVT ALLEGRA System TF

    EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

    Arm Description

    NVT ALLEGRA System TF

    EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Proportion of patients with device success after the Valve In Valve (VIV) procedure
    Device success after the VIV procedure to the VARC-3 criteria
    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
    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.
    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.
    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.
    Trans-aortic mean gradient
    Trans-aortic mean gradient 1 year after TAVR procedure
    Death
    Incidence of Death
    Stroke
    Incidence of Stroke

    Full Information

    First Posted
    August 17, 2023
    Last Updated
    September 17, 2023
    Sponsor
    Fundación EPIC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06049654
    Brief Title
    Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
    Official Title
    Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2025 (Anticipated)
    Study Completion Date
    November 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundación EPIC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Valve Stenosis, Structural Valve Deterioration
    Keywords
    Valve-In-Valve, Aortic stenosis, Aortic regurgitation, Trans-catheter aortic valve, Degenerated aortic valve

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    104 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NVT ALLEGRA System TF
    Arm Type
    Active Comparator
    Arm Description
    NVT ALLEGRA System TF
    Arm Title
    EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
    Arm Type
    Experimental
    Arm Description
    EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
    Intervention Type
    Device
    Intervention Name(s)
    NVT ALLEGRA TAVI System TF
    Intervention Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
    Intervention Description
    Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
    Primary Outcome Measure Information:
    Title
    Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).
    Description
    Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Proportion of patients with device success after the Valve In Valve (VIV) procedure
    Description
    Device success after the VIV procedure to the VARC-3 criteria
    Time Frame
    30 days
    Title
    Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure
    Description
    Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure
    Time Frame
    30 days
    Title
    Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention.
    Description
    Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention.
    Time Frame
    30 days
    Title
    Early safety at 30 days as defined by Valve Academic Research Consortium 3 (VARC-3) criteria
    Description
    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
    Title
    Clinical efficacy at 1 year as defined by VARC-3 criteria
    Description
    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
    Title
    Trans-aortic mean gradient
    Description
    Trans-aortic mean gradient 1 year after TAVR procedure
    Time Frame
    1 year
    Title
    Death
    Description
    Incidence of Death
    Time Frame
    1 year
    Title
    Stroke
    Description
    Incidence of Stroke
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    RAÚL MORENO GÓMEZ, MD, PhD
    Phone
    0034917277000
    Email
    raulmorenog@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    FUNDACION EPIC
    Phone
    0034987876135
    Email
    iepic@fundacionepic.org

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33890713
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32445575
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32592401
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    35597385
    Citation
    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. Erratum In: J Am Coll Cardiol. 2022 Oct 4;80(14):1419.
    Results Reference
    background
    PubMed Identifier
    35393102
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33478639
    Citation
    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. Erratum In: JACC Cardiovasc Interv. 2021 Apr 26;14(8):937-939.
    Results Reference
    background
    PubMed Identifier
    33413929
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs