Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.

• Conditions: Pacing-Induced Cardiomyopathy
• Interventions: Device: Single-chamber pacemaker implantation with left bundle branch area pacing

• Registration Number: NCT05162716
• Lead Sponsor: Nicolas Clementy, MD, PhD

Brief Summary

Permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. We hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular pacing.

Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.

They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation.

They will be prospectively followed during 6 months.

Detailed Description

Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.

They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing confirmed according to electrocardiographic parameters. Atrioventricular node ablation will be performed the following day through a femoral venous approach.

Perioperative data and potential complications will be collected. Patients will be prospectively followed during 6 months. They will have clinical examination, 12-lead ECG, and an echocardiography.

Study Timeline

• Study Start: 2020-05-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Last Update Submitted: 2021-12-08
• Study First Posted: 2021-12-17
• Last Update Posted: 2021-12-17
• Primary Completion: 2022-05-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Permanent atrial arrhythmia
• Symptoms related to an insufficient rate control under optimal medical therapy

Exclusion Criteria

• Indication of prophylactic defibrillator
• Already implanted with a cardiac device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LBBAP	Single-chamber pacemaker implantation with left bundle branch area pacing	Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation.

Primary Outcome Measures

Name	Time	Method
Heart failure hospitalization	6 months	Hospitalization for decompensated heart failure

Secondary Outcome Measures

Name	Time	Method
Complications	30 days	Perioperative complications
Electrical remodeling	6 months	QRS width
Volumetric response	6 months	Left ventricular ejection fraction, left ventricular volumes
Mortality	6 months	Death from any cause

Trial Locations

Locations (1)

CHRU de Tours; 🇫🇷 Tours, Please Select..., France