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

NCT05162716 | Unknown

• 1 other identifier: CROSS-LEFT AF
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacing-Induced Cardiomyopathy

Keywords

left bundle branch area pacing; atrial fibrillation; atrioventricular ablation; pacing-induced cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Heart failure hospitalization

  Hospitalization for decompensated heart failure

  6 months

Secondary Outcomes (4)

• Mortality

  6 months

• Electrical remodeling

  6 months

• Complications

  30 days

• Volumetric response

  6 months

Study Arms (1)

LBBAP

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

Interventions

Single-chamber pacemaker implantation with left bundle branch area pacing DEVICE

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.

Also known as: Atrioventricular junction ablation

LBBAP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated with pacemaker implantation and atrioventricular junction ablation for symptomatic chronic atrial arrhythmia.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nicolas Clementy, MD, PhD: lead
• Dr Arnaud BISSON: collaborator

Study Sites (1)

CHRU de Tours

Tours, Please Select..., 37000, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicolas CLEMENTY

CONTACT

+33618072141; nclementy@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 17, 2021
• Study Start: May 1, 2020
• Primary Completion: May 30, 2022
• Study Completion: October 30, 2022
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

FR (1)