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

Aortic Valve Stenosis Clinical Trial

— WITAVI-REAL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03728049
• Other study ID #: 2017_77
• Secondary ID: 2018-A01175-50PH
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: December 2025

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: Eric Van Belle, MD,PhD
• Phone: 03 20 44 50 15
• Email: eric.vanbelle2[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 944
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Estaing - Chu63 - Clermont Ferrand	Clermont-Ferrand
France	Institut Coeur-Poumon, CHU	Lille
France	Chu Montpellier	Montpellier
France	CHU de Nimes	Nîmes
France	Hu Pitie Salpetriere Aphp - Paris 13	Paris
France	Hopital Haut-Leveque - Chu - Pessac	Pessac
France	Chru Rennes Site Pontchaillou	Rennes
France	Hopital Civil / Nouvel Hopital Civil - Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France, Siemens Healthineers, France

Country where clinical trial is conducted

France, 

Outcome

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