NCT05714579

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Stenosis, Severe

Interventions

Type	Name	Description
PROCEDURE	Transcatheter Aortic Valve Implantation	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.

Timeline

• Start date: 2023-05-30
• Primary completion: 2024-11-20
• Completion: 2024-11-20
• First posted: 2023-02-06
• Last updated: 2025-03-25

Locations

1 site across 1 country: France