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Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Lille
NCT03728049 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical ne

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📋 Eligibility rules (as published)
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
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What it tests

  • CT-ADP performed during TAVI procedure
  • No CT-ADP performed during TAVI procedure
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Where

9 sites
Hopital Estaing - Chu63 - Clermont Ferrand
Clermont-Ferrand, France
Institut Coeur-Poumon, CHU
Lille, France
Chu Montpellier
Montpellier, France
CHU de Nimes
Nîmes, France
Hu Pitie Salpetriere Aphp - Paris 13
Paris, France
Hopital Haut-Leveque - Chu - Pessac
Pessac, France
Chru Rennes Site Pontchaillou
Rennes, France
Hopital Civil / Nouvel Hopital Civil - Strasbourg
Strasbourg, France

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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