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Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study completion date: May 30, 2024 to May 30, 2027
    • Secondary endpoints revised (14)
    • Site details revised
    v10
  2. Re-verified, no change to tracked fieldsv9
  3. Trial status: Recruiting to Active, Not Recruitingv8 Show 5 more changesShow less
    • Interventions: CoreValve (Procedure), Edwards (Procedure), Standard (Procedure) to Acurate neo (Procedure), CoreValve (Procedure), Edwards (Procedure), Standard (Procedure)
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 14 entries
    • Study description expanded, about 10 words
    • Site details revised
  4. Start date: May 30, 2017 to Aug 8, 2017v7
  5. Primary completion date: Dec 30, 2022 to Oct 30, 2023v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: May 30, 2022 to Dec 30, 2022v5
  2. Primary completion date: May 30, 2021 to May 30, 2022v4
  3. Primary completion date: May 30, 2019 to May 30, 2021v3
  4. Primary completion date: May 30, 2018 to May 30, 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS) population with small aortic annuli. Objectives of the present study are to compare the hemodynamic performance (incidence of severe PPM and ≥ moderate AR) and clinical outcomes (death, stroke, major or life threatening bleeding) between TAVR and SAVR in patients with severe AS and small aortic annuli.
Trial Details
NCT Number NCT03383445
Lead Sponsor Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Conditions
(from sponsor)		 Degenerative Aortic Valve Disease, Aortic Stenosis, Aortic Regurgitation
Related terms Aortic Valve Insufficiency, Aortic Valve Stenosis
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov