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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

944 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-18

Study Completion Date

2025-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Aortic Valve Stenosis Aortic Valve Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter open-label randomized controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CT-ADP performed during TAVI procedure

Intervention Type DIAGNOSTIC_TEST

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.

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.

Group Type OTHER

No CT-ADP performed during TAVI procedure

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No