NCT03728049

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 944 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Aortic Valve Stenosis
• Aortic Valve Insufficiency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT-ADP performed during TAVI procedure	The CT-ADP will be performed in the catheterization laboratory and revealed to the operator. The decision to undertake corrective procedure will be based on CT-ADP on top of standard methods of PVR assessment.
OTHER	No CT-ADP performed during TAVI procedure	PVR assessment with the standard methods only (TTE and/or angiography and/or hemodynamics but excluding TEE and CT-ADP). The decision to undertake corrective procedure will be left at the discretion of the operator.

Timeline

• Start date: 2019-12-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2018-11-01
• Last updated: 2023-01-13

Locations

9 sites across 1 country: France