Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes (WITAVI-REAL)
Aortic Valve Stenosis, Aortic Valve Insufficiency
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Transcatheter Aortic Valve Replacement, Paravalvular regurgitation, Point-of-care test, Biomarker, Aortic stenosis, Von willebrand Factor
Eligibility Criteria
Inclusion Criteria:
- All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the inclusion criteria will be eligible for entry in the study. The decision to undertake TAVI will be made by the local heart team.
- Symptomatic aortic stenosis scheduled to undergo TAVI
- TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia/conscious sedation; no TEE guidance.
- All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted
Exclusion Criteria:
- TAVI through non-transfemoral approach
- TAVI with concomitant percutaneous coronary intervention
- TAVI performed under general anesthesia
- TAVI performed under TEE guidance
- Valve-in-valve procedure
- Inability to provide informed consent
- Associated ≥ moderate mitral regurgitation
- Peri-procedural treatment with ticagrelor or prasugrel treatment / direct oral anticoagulant
Sites / Locations
- Hopital Estaing - Chu63 - Clermont FerrandRecruiting
- Institut Coeur-Poumon, CHURecruiting
- Chu Montpellier
- CHU de Nimes
- Hu Pitie Salpetriere Aphp - Paris 13
- Hopital Haut-Leveque - Chu - PessacRecruiting
- Chru Rennes Site Pontchaillou
- Hopital Civil / Nouvel Hopital Civil - Strasbourg
- CHU de ToulouseRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
CT-ADP group
Control group
PVR assessment with the standard methods and with the CT-ADP that will be provided to the operator in real-time during TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator and based on the results of the CT-ADP on top of the standard methods of PVR assessment.
PVR assessment with standard methods only (at discretion of the operator excluding CT-ADP and transesophageal echocardiography). CT-ADP will not be provided to the operator at the time of TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator according to the results of the standard methods of PVR assessment.