Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes (WITAVI-REAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03728049|
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : September 14, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis Aortic Valve Insufficiency||Diagnostic Test: CT-ADP performed during TAVI procedure Other: No CT-ADP performed during TAVI procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||944 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicenter open-label randomized controlled clinical trial|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 18, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
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.
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.
- 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.
- All-cause death rate [ Time Frame: At 30 days, at 1 year ]All-cause death
- PVR rate [ Time Frame: At 30 days, at 1 year ]PVR superior or egal to moderate
- Rehospitalization for heart failure rate [ Time Frame: At 30 days, at 1 year ]Rehospitalization for heart failure
- Delayed valve re-intervention rate [ Time Frame: At 1 year ]Delayed valve re-intervention
- Delayed valve re-intervention rate [ Time Frame: At 30 days, at 1 year ]Delayed valve re-intervention
- Mean transaortic gradient >20mmHg rate [ Time Frame: At 30 days ]Mean transaortic gradient >20mmHg
- 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
- composite event rate of the following individual safety endpoints [ Time Frame: at 24hours ]Aortic injury; Coronary artery occlusion; Tamponade; All stroke (transient or definite)
- Aortic injury rate [ Time Frame: at 24hours ]Aortic injury
- Coronary artery occlusion rate [ Time Frame: at 24hours ]Coronary artery occlusion
- Tamponade rate [ Time Frame: at 24hours ]Tamponade
- All stroke (transient or definite) rate [ Time Frame: at 24hours ]All stroke (transient or definite)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728049
|Contact: Eric Vanbelle, MD,PhD||03 20 44 50 15 ext +email@example.com|
|Contact: Flavien Vincent, MD||03 20 44 59 62 (29625) ext +firstname.lastname@example.org|
|Institut Coeur-Poumon, CHU||Recruiting|
|Lille, France, 59037|
|Principal Investigator: Eric VAN BELLE, MD,PhD|
|Principal Investigator:||Eric Vanbelle, MD||University Hospital, Lille|