Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes (WITAVI-REAL)

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    944
  • sponsor
    University Hospital, Lille
Updated on 27 May 2022
stenosis
regurgitation
aortic valve stenosis
transcatheter aortic valve implantation
tavi
symptomatic aortic stenosis
point-of-care testing

Summary

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 need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.

The hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).

Details
Condition Aortic Valve Stenosis, Aortic Valve Insufficiency
Treatment CT-ADP performed during TAVI procedure, No CT-ADP performed during TAVI procedure
Clinical Study IdentifierNCT03728049
SponsorUniversity Hospital, Lille
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

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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