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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency
• Intervention / Treatment: Diagnostic test: CT-ADP performed during TAVI procedure; Other: No CT-ADP performed during TAVI procedure

• Study Type: Interventional
• Enrollment (Estimated): 944
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Van Belle, MD,PhD; Phone Number: +33 03 20 44 50 15; Email: eric.vanbelle2@chru-lille.fr
• Study Contact Backup: Name: Flavien Vincent, MD, PhD; Phone Number: +33 03 20 44 59 62 (31588); Email: flavien.vincent@chru-lille.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • Hopital Estaing - Chu63 - Clermont Ferrand
  • Lille, France, 59037
    • Recruiting
    • Institut Coeur-Poumon, CHU
    • Principal Investigator: Eric VAN BELLE, MD,PhD
    • Contact: Phone Number: 0320445962
  • Montpellier, France
    • Not yet recruiting
    • CHU Montpellier
  • Nîmes, France
    • Not yet recruiting
    • CHU de Nîmes
  • Paris, France
    • Not yet recruiting
    • Hu Pitie Salpetriere Aphp - Paris 13
  • Pessac, France, 33604
    • Recruiting
    • Hopital Haut-Leveque - Chu - Pessac
  • Rennes, France
    • Not yet recruiting
    • Chru Rennes Site Pontchaillou
  • Strasbourg, France
    • Not yet recruiting
    • Hopital Civil / Nouvel Hopital Civil - Strasbourg
  • Toulouse, France
    • Recruiting
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-ADP group; PVR assessment with the standard methods and with the CT-ADP that will be provided to the operator in real-time during TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator and based on the results of the CT-ADP on top of the standard methods of PVR assessment.	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: Control group; PVR assessment with standard methods only (at discretion of the operator excluding CT-ADP and transesophageal echocardiography). CT-ADP will not be provided to the operator at the time of TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator according to the results of the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite 1-year event rate of	rate of All-cause death; rate of Paravalvular regurgitation ≥ moderate; rate of Rehospitalization; rate of Stroke; rate of Delayed valve re-intervention; rate of Mean transaortic gradient >20mmHg.	At 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death rate	All-cause death	At 30 days, at 1 year
PVR rate	PVR superior or egal to moderate	At 30 days, at 1 year
Rehospitalization for heart failure rate	Rehospitalization for heart failure	At 30 days, at 1 year
Delayed valve re-intervention rate	Delayed valve re-intervention	At 1 year
Delayed valve re-intervention rate	Delayed valve re-intervention	At 30 days, at 1 year
Mean transaortic gradient >20mmHg rate	Mean transaortic gradient >20mmHg	At 30 days
composite event rate	All-cause death; PVR superior or egal to moderate; Rehospitalization for heart failure; All stroke (transient or definite); Delayed valve re-intervention; Mean transaortic gradient >20mmHg	At 30 days
composite event rate of the following individual safety endpoints	Aortic injury; Coronary artery occlusion; Tamponade; All stroke (transient or definite)	at 24hours
Aortic injury rate	Aortic injury	at 24hours
Coronary artery occlusion rate	Coronary artery occlusion	at 24hours
Tamponade rate	Tamponade	at 24hours
All stroke (transient or definite) rate	All stroke (transient or definite)	at 24hours

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Siemens Healthineers, France
• Investigators: Principal Investigator: Eric Vanbelle, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Biomarker; Transcatheter Aortic Valve Replacement; Aortic stenosis; Point-of-care test; Paravalvular regurgitation; Von willebrand Factor
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: 2017_77; 2018-A01175-50 (Other Identifier: ID-RCB number, ANSM); PHRC-17-0697 (Other Identifier: PHRC number, DGOS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No