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NCT05261204 · ClinicalTrials.gov record · last posted 2026-08-19

Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement

Study acronym: TAVISAR
StatusActive, Not Recruiting
PhaseNot specified
Started2013-01-01
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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).

Protocol amendment history 3 changes detected by DataLookout

2026-08-20
notable
Trial status changed: Enrolling by Invitation → Active, Not Recruiting
2026-07-29
critical
Primary endpoint(s) modified
WasHospitalizations for Heart Failure (HF), Treatment failure
NowDetermining Device Malfunction Through CT Evaluation of the Aortic Root, Hospitalizations for Heart Failure (HF), Predictive Determination of Device Malfunction Through FEA of the Aortic Root, Treatment failure
2026-07-29
minor
Completion pushed: 2027-05-31 → 2029-05-31
Trial Details
NCT Number NCT05261204
Lead Sponsor Centre Cardiologique du Nord
Collaborators: Henri Mondor University Hospital, Universita degli Studi di Genova
Conditions Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Enrollment 4,000 participants
Start Date 2013-01-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2029-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-19