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

Pacing-Induced Cardiomyopathy Clinical Trial

— CROSS-LEFT-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05162716
• Other study ID #: CROSS-LEFT AF
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: December 2021
• Source: University Hospital, Tours
• Contact: Nicolas CLEMENTY
• Phone: +33618072141
• Email: nclementy[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Pacing-Induced Cardiomyopathy

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Tours	Tours	Please Select...

Sponsors (2)

Lead Sponsor	Collaborator
Nicolas Clementy, MD, PhD	Dr Arnaud BISSON

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart failure hospitalization	Hospitalization for decompensated heart failure	6 months
Secondary	Mortality	Death from any cause	6 months
Secondary	Electrical remodeling	QRS width	6 months
Secondary	Complications	Perioperative complications	30 days
Secondary	Volumetric response	Left ventricular ejection fraction, left ventricular volumes	6 months