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

NCT ID: NCT05162716

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2022-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pacing-Induced Cardiomyopathy

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Single-chamber pacemaker implantation with left bundle branch area pacing

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Atrioventricular junction ablation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Arnaud BISSON

UNKNOWN

Sponsor Role collaborator

Nicolas Clementy, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Nicolas Clementy, MD, PhD

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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CHRU de Tours

Tours, Please Select..., France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas CLEMENTY

Role: CONTACT

Phone: +33618072141

Email: [email protected]

Facility Contacts

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Nicolas CLEMENTY, MD, PhD

Role: primary

Other Identifiers

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CROSS-LEFT AF

Identifier Type: -

Identifier Source: org_study_id