Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pacing-Induced Cardiomyopathy
- Sponsor
- Nicolas Clementy, MD, PhD
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Heart failure hospitalization
- Last Updated
- 4 years ago
Overview
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.
Investigators
Nicolas Clementy, MD, PhD
Associate Professor
University Hospital, Tours
Eligibility Criteria
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
Outcomes
Primary Outcomes
Heart failure hospitalization
Time Frame: 6 months
Hospitalization for decompensated heart failure
Secondary Outcomes
- Complications(30 days)
- Mortality(6 months)
- Electrical remodeling(6 months)
- Volumetric response(6 months)