Improving TAVI outcomes with point-of-care testing for Von Willebrand Factor
Point-of-care Haemostasis Testing of Von Willebrand Factor Function Embedded in Catheterization Laboratory to Improve Real-time Management of Paravalvular Regurgitation During Minimally Invasive TAVI
NA · University Hospital, Lille · NCT03728049
This study is testing whether quick testing for Von Willebrand Factor during TAVI procedures can help improve outcomes and reduce complications for patients with aortic stenosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 944 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille (other) |
| Locations | 9 sites (Clermont-Ferrand and 8 other locations) |
| Trial ID | NCT03728049 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic aortic stenosis scheduled for a minimally invasive TAVI procedure using transfemoral access and conscious sedation.
Not a fit: Patients who are undergoing TAVI through non-transfemoral approaches or under general anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of paravalvular regurgitation and improve survival rates for patients undergoing TAVI.
How similar studies have performed: While there have been studies on TAVI outcomes, this specific approach using point-of-care testing for Von Willebrand Factor is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clermont-Ferrand and 8 other locations
- Hopital Estaing - Chu63 - Clermont Ferrand — Clermont-Ferrand, France (RECRUITING)
- Institut Coeur-Poumon, CHU — Lille, France (RECRUITING)
- Chu Montpellier — Montpellier, France (NOT_YET_RECRUITING)
- CHU de Nimes — Nîmes, France (NOT_YET_RECRUITING)
- Hu Pitie Salpetriere Aphp - Paris 13 — Paris, France (NOT_YET_RECRUITING)
- Hopital Haut-Leveque - Chu - Pessac — Pessac, France (RECRUITING)
- Chru Rennes Site Pontchaillou — Rennes, France (NOT_YET_RECRUITING)
- Hopital Civil / Nouvel Hopital Civil - Strasbourg — Strasbourg, France (NOT_YET_RECRUITING)
- CHU de Toulouse — Toulouse, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Valve Stenosis, Aortic Valve Insufficiency, Transcatheter Aortic Valve Replacement, Paravalvular regurgitation, Point-of-care test, Biomarker, Aortic stenosis, Von willebrand Factor