- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03728049
Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes (WITAVI-REAL)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eric Van Belle, MD,PhD
- Phone Number: +33 03 20 44 50 15
- Email: eric.vanbelle2@chru-lille.fr
Study Contact Backup
- Name: Flavien Vincent, MD, PhD
- Phone Number: +33 03 20 44 59 62 (31588)
- Email: flavien.vincent@chru-lille.fr
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Eric Vanbelle, MD, PhD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
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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