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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pacing-Induced Cardiomyopathy

Intervention / Treatment
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* Device: Single-chamber pacemaker implantation with left bundle branch area pacing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LBBAP<br>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. | Device: Single-chamber pacemaker implantation with left bundle branch area pacing<br>* A prepectoral single-chamber pacemaker is implanted with a 3830 (Medtronic) IS-1 pacing lead screwed via the right ventricle in the deep interventricular septum in order to capture the left Purkinje system on the left ventricular endocardial side.<br>* Other names: Atrioventricular junction ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure hospitalization | Hospitalization for decompensated heart failure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death from any cause | 6 months | 
| Electrical remodeling | QRS width | 6 months | 
| Complications | Perioperative complications | 30 days | 
| Volumetric response | Left ventricular ejection fraction, left ventricular volumes | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left bundle branch area pacing; atrial fibrillation; atrioventricular ablation; pacing-induced cardiomyopathy