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

December 8, 2021 updated by: Nicolas Clementy, MD, PhD

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Please Select...
      • Tours, Please Select..., France, 37000
        • Recruiting
        • CHRU de Tours
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 6 months
Hospitalization for decompensated heart failure
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 6 months
Death from any cause
6 months
Electrical remodeling
Time Frame: 6 months
QRS width
6 months
Complications
Time Frame: 30 days
Perioperative complications
30 days
Volumetric response
Time Frame: 6 months
Left ventricular ejection fraction, left ventricular volumes
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicolas Clementy, MD, PhD

Collaborators

Dr Arnaud BISSON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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