Back to resultsPredictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block (TAVHIS)
Primary Purpose
Aortic Stenosis, Severe
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcatheter Aortic Valve Implantation
Sponsored by
About this trial
This is an interventional diagnostic trial for Aortic Stenosis, Severe
Eligibility Criteria
Inclusion Criteria: Patient suffering from severe aortic stenosis, eligible for a TAVI procedure (Transcatheter Aortic Valve Implantation) ; Patient presenting with complete right bundle branch block during the pre-TAVI electrocardiogram, with QRS interval ≥ 120 ms (depolarization of the ventricles); Patient able to understand the information related to the study, to read the information leaflet and agreeing to participate in the study. ; Patient having signed a consent. Exclusion Criteria: Contraindication to Transcatheter Aortic Valve Implantation ; Patient under guardianship or curatorship, or under a regime of deprivation of liberty; Patient participating in another clinical trial, or in a period of exclusion from another clinical trial; Patient not benefiting from a social security scheme.
Sites / Locations
- Hôpital Privé MédipôleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
severe aortic stenosis with complete right bundle branch block
Arm Description
patients with aortic stenosis undergoing a Transcatheter Aortic Valve Implantation procedure
Outcomes
Primary Outcome Measures
Implantation of a Pacemaker at 30 days
Implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
Secondary Outcome Measures
Full Information
NCT ID
NCT05714579
First Posted
January 27, 2023
Last Updated
June 6, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05714579
Brief Title
Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block
Acronym
TAVHIS
Official Title
Predictive Value of Pre-Transcatheter Aortic Valve Implantation (TAVI) Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block in Patients With Preoperative Right Bundle Branch Block
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
Detailed Description
The main objective is to assess the predictive value of the pre-TAVI infrahelic conduction time interval (infraheal conduction time measured before percutaneous aortic valve implantation) on the risk of Pacemaker implantation at 30 days post-TAVI, in patients with right bundle branch block prior to surgery.
The aim of the study is to identify a pre-interventional marker of the risk of rhythmological complication after the TAVI procedure (Transcatheter Aortic Valve Implantation), in order to better anticipate it.
This is an interventional, prospective, longitudinal (follow-up: 12 months), multicenter (4 centers) study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Severe
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
severe aortic stenosis with complete right bundle branch block
Arm Type
Experimental
Arm Description
patients with aortic stenosis undergoing a Transcatheter Aortic Valve Implantation procedure
Intervention Type
Procedure
Intervention Name(s)
Transcatheter Aortic Valve Implantation
Intervention Description
The TAVI procedure is performed transfemorally under local anesthesia most often, or more rarely under general anesthesia via the subclavian or transaortic route. Identification is carried out under fluoroscopy in the cardiac catheterization room. The crossing of the aortic valve allows the establishment of a guide at the bottom of the left ventricle. Aortic valve predilation can be performed. The tightness of the device is checked by an aortography. Sometimes, post-dilation of the implanted bioprosthesis proves necessary, particularly in the event of under-deployment or significant para-prosthetic leakage.
The duration of the intervention is approximately 1 hour.
Primary Outcome Measure Information:
Title
Implantation of a Pacemaker at 30 days
Description
Implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient suffering from severe aortic stenosis, eligible for a TAVI procedure (Transcatheter Aortic Valve Implantation) ;
Patient presenting with complete right bundle branch block during the pre-TAVI electrocardiogram, with QRS interval ≥ 120 ms (depolarization of the ventricles);
Patient able to understand the information related to the study, to read the information leaflet and agreeing to participate in the study. ;
Patient having signed a consent.
Exclusion Criteria:
Contraindication to Transcatheter Aortic Valve Implantation ;
Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
Patient not benefiting from a social security scheme.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oualid ZOUAGHI, MD
Phone
666687365
Ext
+33
Email
ozouaghi@cardiopole.fr
Facility Information:
Facility Name
Hôpital Privé Médipôle
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oualid ZOUAGHI, MD
Email
ozouaghi@cardiopole.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block
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