Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPoitiers University Hospital
About this trial
The goal of this clinical trial is to learn whether left bundle branch area pacing, a technique designed to activate the heart's natural electrical conduction system, is better than conventional right ventricular pacing in adults with permanent atrial fibrillation, preserved heart pumping function, and a need for a pacemaker.
The main questions it aims to answer are:
Does left bundle branch area pacing reduce the risk of death, unplanned hospitalization for heart failure, or the need to replace the initial pacing system with biventricular pacing over 2 years? Does it better preserve heart function and quality of life, without increasing pacemaker-related complications?
Researchers will compare left bundle branch area pacing with conventional right ventricular pacing. A total of 642 participants will be randomly assigned to receive one of these two pacing strategies.
Participants will:
Have a single-chamber pacemaker implanted using either left bundle branch area pacing or conventional right ventricular pacing Undergo electrocardiograms, echocardiograms, and pacemaker checks during 2 years of follow-up Attend follow-up visits approximately 2, 12, and 24 months after implantation Be contacted by telephone approximately 6 and 18 months after implantation Complete questionnaires about their health and quality of life at the beginning and end of the study
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years and <90 years
Atrial fibrillation requiring ventricular pacing because of
rapid atrial fibrillation requiring atrioventricular node ablation; or
slow atrial fibrillation i.e. ≤ 50 bpm on admission ECG).
Disqualifiers
Indication for an implantable cardioverter defibrillator.
Presence of a mechanical tricuspid valve
Any prior attempt at implantation of an implantable cardioverter defibrillator, cardiac resynchronization therapy or LBBA pacing
Glomerular filtration rate <40 mL/min/1,73m2 with CKD-EPI formula
Trial design
Design model
Parallel
Treatments tested in this trial
LBBA pacing
Procedure/SurgeryThe LBBA pacing group will be composed of patients randomized to receive a single chamber pacemaker with a ventricular lead implanted in the LBBA of the cardiac conduction system through the interventricular septum.
Conventional pacing
Procedure/SurgeryThe conventional pacing group will be composed of patients randomized to receive a single chamber pacemaker with a ventricular lead implanted either at the apex or the septum of the right ventricle.
Treatment groups
642 Participants
are divided into 2 treatment groupsGroup A: LBBA pacingExperimental treatment 1 intervention
Group B: Conventional pacingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of post-implantation adverse events
proportion of post-implantation adverse events, combining all-cause mortality, unplanned hospitalization related to heart failure, and upgrade to biventricular pacing.
Time frame
At two yearsSecondary outcomes
1
Left ventricular ejection fraction
Left ventricular ejection fraction assessed with echocardiography
Time frame
At 2 years post-implantation.2
Left ventricular end-systolic volume
Left ventricular end-systolic volume assessed with echocardiography
Time frame
At 2 years post-implantation3
Time to composite outcome
Time to the first event between death, unplanned hospitalization related to heart failure, and upgrade to biventricular during the 2-year follow-up period
Time frame
Through study completion, an average of 2 years4
Unplanned hospitalization related to heart failure
Time to unplanned hospitalization for heart failure
Time frame
During the 2-year follow-up perioLocations
Sponsors and contacts
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Poitiers University Hospital
Lead sponsor
University Hospital, Grenoble
Collaborator
Nouvelles Cliniques Nantaises, Nantes
Collaborator
Centre Hospitalier Universitaire de Besancon
Collaborator
Centre Hospitalier de PAU
Collaborator
Centre Cardiologique du Nord, St Denis
Collaborator
Centre Hospitalier Universitaire de Saint Etienne
Collaborator
LA ROCHE SUR YON HOSPITAL
Collaborator
Centre Hospitalier Régional d'Orléans
Collaborator
University Hospital, Tours
Collaborator
Source ClinicalTrials.gov
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