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

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.

Study Overview

• Status: Recruiting
• Conditions: Pacing-Induced Cardiomyopathy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Nicolas CLEMENTY; Phone Number: +33618072141; Email: nclementy@yahoo.fr

Study Locations

• France
  • Please Select...
    • Tours, Please Select..., France, 37000
      • Recruiting
      • CHRU de Tours
      • Contact: Nicolas CLEMENTY, MD, PhD; Phone Number: 0033247474747; Email: nclementy@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nicolas Clementy, MD, PhD
• Collaborators: Dr Arnaud BISSON

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: left bundle branch area pacing; atrial fibrillation; atrioventricular ablation; pacing-induced cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: CROSS-LEFT AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No