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

Primary Purpose

Aortic Valve Stenosis, Aortic Valve Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CT-ADP performed during TAVI procedure
No CT-ADP performed during TAVI procedure
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Transcatheter Aortic Valve Replacement, Paravalvular regurgitation, Point-of-care test, Biomarker, Aortic stenosis, Von willebrand Factor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Estaing - Chu63 - Clermont FerrandRecruiting
  • Institut Coeur-Poumon, CHURecruiting
  • Chu Montpellier
  • CHU de Nimes
  • Hu Pitie Salpetriere Aphp - Paris 13
  • Hopital Haut-Leveque - Chu - PessacRecruiting
  • Chru Rennes Site Pontchaillou
  • Hopital Civil / Nouvel Hopital Civil - Strasbourg
  • CHU de ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CT-ADP group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

composite 1-year event rate of
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

All-cause death rate
All-cause death
PVR rate
PVR superior or egal to moderate
Rehospitalization for heart failure rate
Rehospitalization for heart failure
Delayed valve re-intervention rate
Delayed valve re-intervention
Delayed valve re-intervention rate
Delayed valve re-intervention
Mean transaortic gradient >20mmHg rate
Mean transaortic gradient >20mmHg
composite event rate
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
Aortic injury; Coronary artery occlusion; Tamponade; All stroke (transient or definite)
Aortic injury rate
Aortic injury
Coronary artery occlusion rate
Coronary artery occlusion
Tamponade rate
Tamponade
All stroke (transient or definite) rate
All stroke (transient or definite)

Full Information

First Posted
October 30, 2018
Last Updated
January 12, 2023
Sponsor
University Hospital, Lille
Collaborators
Siemens Healthineers, France, Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT03728049
Brief Title
Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes
Acronym
WITAVI-REAL
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Siemens Healthineers, France, Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Aortic Valve Insufficiency
Keywords
Transcatheter Aortic Valve Replacement, Paravalvular regurgitation, Point-of-care test, Biomarker, Aortic stenosis, Von willebrand Factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter open-label randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
944 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT-ADP group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT-ADP performed during TAVI procedure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No CT-ADP performed during TAVI procedure
Intervention Description
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 Measure Information:
Title
composite 1-year event rate of
Description
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.
Time Frame
At 1 year
Secondary Outcome Measure Information:
Title
All-cause death rate
Description
All-cause death
Time Frame
At 30 days, at 1 year
Title
PVR rate
Description
PVR superior or egal to moderate
Time Frame
At 30 days, at 1 year
Title
Rehospitalization for heart failure rate
Description
Rehospitalization for heart failure
Time Frame
At 30 days, at 1 year
Title
Delayed valve re-intervention rate
Description
Delayed valve re-intervention
Time Frame
At 1 year
Title
Delayed valve re-intervention rate
Description
Delayed valve re-intervention
Time Frame
At 30 days, at 1 year
Title
Mean transaortic gradient >20mmHg rate
Description
Mean transaortic gradient >20mmHg
Time Frame
At 30 days
Title
composite event rate
Description
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
Time Frame
At 30 days
Title
composite event rate of the following individual safety endpoints
Description
Aortic injury; Coronary artery occlusion; Tamponade; All stroke (transient or definite)
Time Frame
at 24hours
Title
Aortic injury rate
Description
Aortic injury
Time Frame
at 24hours
Title
Coronary artery occlusion rate
Description
Coronary artery occlusion
Time Frame
at 24hours
Title
Tamponade rate
Description
Tamponade
Time Frame
at 24hours
Title
All stroke (transient or definite) rate
Description
All stroke (transient or definite)
Time Frame
at 24hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Van Belle, MD,PhD
Phone
03 20 44 50 15
Ext
+33
Email
eric.vanbelle2@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Flavien Vincent, MD, PhD
Phone
03 20 44 59 62 (31588)
Ext
+33
Email
flavien.vincent@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Vanbelle, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Estaing - Chu63 - Clermont Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Coeur-Poumon, CHU
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
First Name & Middle Initial & Last Name & Degree
Eric VAN BELLE, MD,PhD
Facility Name
Chu Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU de Nimes
City
Nîmes
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hu Pitie Salpetriere Aphp - Paris 13
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Haut-Leveque - Chu - Pessac
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Chru Rennes Site Pontchaillou
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Civil / Nouvel Hopital Civil - Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes

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