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

May 20, 2026 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
944

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Siemens Healthineers, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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