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

Sponsor

Nicolas Clementy, MD, PhD (Other)

Overall Status

Recruiting

CT.gov ID

NCT05162716

Collaborator

Dr Arnaud BISSON (Other)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacing-Induced Cardiomyopathy	Device: Single-chamber pacemaker implantation with left bundle branch area pacing

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

May 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 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. Other Names: Atrioventricular junction ablation

Arm

Intervention/Treatment

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

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.

Other Names:

Atrioventricular junction ablation

Outcome Measures

Primary Outcome Measures

Heart failure hospitalization [6 months]
Hospitalization for decompensated heart failure

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Tours	Tours	Please Select...	France	37000

Sponsors and Collaborators

Nicolas Clementy, MD, PhD
Dr Arnaud BISSON

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nicolas Clementy, MD, PhD, Associate Professor, University Hospital, Tours

ClinicalTrials.gov Identifier:

NCT05162716

Other Study ID Numbers:

CROSS-LEFT AF

First Posted:

Dec 17, 2021

Last Update Posted:

Dec 17, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nicolas Clementy, MD, PhD, Associate Professor, University Hospital, Tours

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

Additional relevant MeSH terms:

Cardiomyopathies

Study Results

No Results Posted as of Dec 17, 2021