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Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients. (CROSS-LEFT-AF)

N

Nicolas Clementy, MD, PhD

Status

Unknown

Conditions

Pacing-Induced Cardiomyopathy

Treatments

Device: Single-chamber pacemaker implantation with left bundle branch area pacing

Study type

Observational

Funder types

Other

Identifiers

NCT05162716
CROSS-LEFT AF

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

LBBAP
Description:
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.
Treatment:
Device: Single-chamber pacemaker implantation with left bundle branch area pacing

Trial contacts and locations

1

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Central trial contact

Nicolas CLEMENTY

Data sourced from clinicaltrials.gov

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