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

Launched by UNIVERSITY HOSPITAL, LILLE · Oct 30, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new way to check for a complication called paravalvular regurgitation (PVR) during a minimally invasive heart procedure known as Transcatheter Aortic Valve Implantation (TAVI). PVR can increase the risk of serious problems after the procedure, so it's important for doctors to accurately assess it. Traditionally, doctors use a method called transesophageal echocardiography (TEE), which requires general anesthesia. However, this trial is exploring whether a simpler blood test that measures the activity of a protein called Von Willebrand factor (VWF) can help detect PVR without needing TEE, potentially leading to better outcomes for patients.

To be eligible for this trial, patients must be scheduled for a mini-invasive TAVI using a transfemoral approach (where the procedure is done through the groin) and under conscious sedation instead of general anesthesia. The trial welcomes all patients who are experiencing symptoms from aortic stenosis, a condition where the heart's aortic valve is narrowed. Participants will have their VWF activity measured during the procedure and will be monitored for any complications. This study could help improve the safety and effectiveness of TAVI for many patients.

Gender

ALL

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