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Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement

Study acronym: TAVISAR
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 2 → 4 primary endpoints
See other at-risk trials from Centre Cardiologique du Nord

Record History

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  1. Trial status changed: Enrolling by Invitation → Active, Not Recruitingv9
  2. Primary endpoint(s) modified
    • Study completion pushed from May 31, 2027 to May 31, 2029
    • Study description expanded, about 56 words
    • Site details revised
    v8
  3. Primary completion date: May 1, 2025 to Dec 1, 2026
    • Study completion date: Dec 31, 2025 to May 31, 2027
    v7
  4. Study title revisedv6
  5. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Enrollment target: 1950 to 4000
    • Start date: May 19, 2022 to Jan 1, 2013
    • Collaborators: 5 to 2
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: May 1, 2024 to May 1, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v4
  2. Primary completion date: Dec 1, 2023 to May 1, 2024
    • Study completion date: Mar 1, 2024 to Dec 31, 2024
    v3
  3. Primary completion date: Dec 1, 2022 to Dec 1, 2023
    • Start date: Feb 19, 2022 to May 19, 2022
    • Study completion date: Mar 1, 2023 to Mar 1, 2024
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI). The key question of this study is to establish the difference in all-cause and cause-specific (cardiac vs noncardiac) mortality, all hospitalizations for heart failure within 24 months of follow-up, left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-diastolic volume (LVEDV), in patients who received the TAVI vs the standard surgical procedure for AVS. Any potential failure of the devices in question will be thoroughly investigated by means of CT scanning and biomechanical computational modelling, utilising finite element analysis (FEA).
Trial Details
NCT Number NCT05261204
Lead Sponsor Centre Cardiologique du Nord
Collaborators: Henri Mondor University Hospital, Universita degli Studi di Genova
Conditions
(from sponsor)		 Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Related terms Prosthesis Failure
Enrollment 4,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov