Improving TAVI outcomes with point-of-care testing for Von Willebrand Factor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of point-of-care testing for Von Willebrand Factor during Transcatheter Aortic Valve Implantation (TAVI) procedures. The study focuses on patients with symptomatic aortic stenosis undergoing a minimally invasive TAVI approach without transesophageal echocardiography (TEE) guidance. By assessing the presence and severity of paravalvular regurgitation (PVR) in real-time, the trial seeks to optimize patient outcomes and reduce the risk of complications associated with TAVI. The intervention involves comparing outcomes between patients who receive the point-of-care test and those who do not.

Why it matters

Who can join: the full rules

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

Where it's running

• Hopital Estaing - Chu63 - Clermont Ferrand
  Clermont-Ferrand, France Recruiting
• Institut Coeur-Poumon, CHU
  Lille, France Recruiting
• Hopital Haut-Leveque - Chu - Pessac
  Pessac, France Recruiting
• CHU de Toulouse
  Toulouse, France Recruiting
• Chu Montpellier
  Montpellier, France Not yet recruiting
• CHU de Nimes
  Nîmes, France Not yet recruiting

Study contacts

• Principal investigator: Eric Vanbelle, MD, PhD — University Hospital, Lille
• Study coordinator: Eric Van Belle, MD,PhD
• Email: eric.vanbelle2@chru-lille.fr
• Phone: 03 20 44 50 15

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• CHATEAU Registry: Real-world outcomes after TAVR

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.