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

January 12, 2023 updated by: University Hospital, Lille

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

Study Type

Interventional

Enrollment (Anticipated)

944

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Clermont-Ferrand, France
        • Recruiting
        • Hopital Estaing - Chu63 - Clermont Ferrand
      • Lille, France, 59037
        • Recruiting
        • Institut Coeur-Poumon, CHU
        • Principal Investigator:
          • Eric VAN BELLE, MD,PhD
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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.
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
Time Frame: 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.
At 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric Vanbelle, MD, PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2019

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

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 (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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