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

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ClinicalTrials.gov Identifier: NCT03728049
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : September 14, 2020
Sponsor:
Collaborators:
Siemens Healthineers, France
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 944 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter open-label randomized controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.
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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. All-cause death rate [ Time Frame: At 30 days, at 1 year ]
    All-cause death

  2. PVR rate [ Time Frame: At 30 days, at 1 year ]
    PVR superior or egal to moderate

  3. Rehospitalization for heart failure rate [ Time Frame: At 30 days, at 1 year ]
    Rehospitalization for heart failure

  4. Delayed valve re-intervention rate [ Time Frame: At 1 year ]
    Delayed valve re-intervention

  5. Delayed valve re-intervention rate [ Time Frame: At 30 days, at 1 year ]
    Delayed valve re-intervention

  6. Mean transaortic gradient >20mmHg rate [ Time Frame: At 30 days ]
    Mean transaortic gradient >20mmHg

  7. 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

  8. composite event rate of the following individual safety endpoints [ Time Frame: at 24hours ]
    Aortic injury; Coronary artery occlusion; Tamponade; All stroke (transient or definite)

  9. Aortic injury rate [ Time Frame: at 24hours ]
    Aortic injury

  10. Coronary artery occlusion rate [ Time Frame: at 24hours ]
    Coronary artery occlusion

  11. Tamponade rate [ Time Frame: at 24hours ]
    Tamponade

  12. All stroke (transient or definite) rate [ Time Frame: at 24hours ]
    All stroke (transient or definite)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Eric Vanbelle, MD,PhD 03 20 44 50 15 ext +33 eric.vanbelle2@chru-lille.fr
Contact: Flavien Vincent, MD 03 20 44 59 62 (29625) ext +33 flavien.vincent@chru-lille.fr

Locations
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France
Institut Coeur-Poumon, CHU Recruiting
Lille, France, 59037
Contact    0320445962      
Principal Investigator: Eric VAN BELLE, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Siemens Healthineers, France
Ministry of Health, France
Investigators
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Principal Investigator: Eric Vanbelle, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03728049    
Other Study ID Numbers: 2017_77
2018-A01175-50 ( Other Identifier: ID-RCB number, ANSM )
PHRC-17-0697 ( Other Identifier: PHRC number, DGOS )
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Transcatheter Aortic Valve Replacement
Paravalvular regurgitation
Point-of-care test
Biomarker
Aortic stenosis
Von willebrand Factor
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction