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

Not Applicable

Recruiting

• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency
• Interventions: Diagnostic Test: CT-ADP performed during TAVI procedure; Other: No CT-ADP performed during TAVI procedure

• Registration Number: NCT03728049
• Lead Sponsor: University Hospital, Lille

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-11-01
• Study Start: 2019-12-18
• Status Verified: 2022-05
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 944

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-ADP group	CT-ADP performed during TAVI procedure	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.
Control group	No CT-ADP performed during TAVI procedure	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.

Primary Outcome Measures

Name	Time	Method
composite 1-year event rate of	At 1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Hopital Estaing - Chu63 - Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

Chru Rennes Site Pontchaillou; 🇫🇷 Rennes, France

Institut Coeur-Poumon, CHU; 🇫🇷 Lille, France

Chu Montpellier; 🇫🇷 Montpellier, France

Hu Pitie Salpetriere Aphp - Paris 13; 🇫🇷 Paris, France

Hopital Haut-Leveque - Chu - Pessac; 🇫🇷 Pessac, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU de Nimes; 🇫🇷 Nîmes, France

Hopital Civil / Nouvel Hopital Civil - Strasbourg; 🇫🇷 Strasbourg, France