Viewing Study NCT03728049



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Last Modification Date: 2024-10-26 @ 12:57 PM
Study NCT ID: NCT03728049
Status: RECRUITING
Last Update Posted: 2023-01-13
First Post: 2018-10-30

Brief Title: Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes
Sponsor: University Hospital Lille
Organization: University Hospital Lille

Study Overview

Official Title: 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: RECRUITING
Status Verified Date: 2022-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: WITAVI-REAL
Brief Summary: Paravalvular regurgitation PVR is an important complication of Transcatheter Aortic Valve Implantation TAVI that is associated with a 25-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 TEEGA the PARTNERII trial has demonstrated that very low rate of PVR 35 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 ie 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2018-A01175-50 OTHER None None
PHRC-17-0697 OTHER PHRC number DGOS None