Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block

NCT05714579 | Terminated

• 1 other identifier: 2022-A02274-39
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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)

Conditions

Aortic Stenosis, Severe

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days

Study Arms (1)

severe aortic stenosis with complete right bundle branch block

EXPERIMENTAL

patients with aortic stenosis undergoing a Transcatheter Aortic Valve Implantation procedure

Procedure: Transcatheter Aortic Valve Implantation

Interventions

Transcatheter Aortic Valve Implantation PROCEDURE

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.

severe aortic stenosis with complete right bundle branch block

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contraindication to Transcatheter Aortic Valve Implantation ;
• Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
• Patient not benefiting from a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé Médipôle

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: May 30, 2023
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)