An interventional study of Pacemaker implantation using left bundle branch area stimulation and Right ventricular pacemaker implantation in Atrioventricular Block and Pacemaker, sponsored by Nantes University Hospital. Recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other
Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021. A common complication following TAVI is traumatic atrioventricular block requiring pacemaker implantation, occurring in about 10% of patients. Conventional right ventricular pacing in these cases often leads to interventricular dyssynchrony, which can impair left ventricular ejection fraction and increase the risk of hospitalization, heart failure, and mortality.
Cardiac resynchronization therapy via biventricular pacing is sometimes proposed as a secondary intervention but involves additional surgery. A newer pacing technique-selective left bundle branch area pacing-has been developed to provide physiological ventricular activation by stimulating conduction pathways distal to the lesion, thereby avoiding dyssynchrony. Retrospective studies suggest clinical benefits, but no prospective randomized trial has yet evaluated its efficacy compared to standard pacing.
The objective of this study is to conduct the first randomized clinical trial comparing left bundle branch area pacing versus conventional right ventricular pacing in patients requiring pacemaker implantation due to atrioventricular block after TAVI.
117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.
This study's planned enrollment of 266 is above the median of 127 across 78 interventional studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pacemaker implantation using left bundle branch area stimulation
Procedure: Pacemaker implantation using left bundle branch area stimulation
Right ventricular pacemaker implantation
Procedure: Right ventricular pacemaker implantation
Pacemaker implantation using left bundle branch area stimulation
Right ventricular pacemaker implantation
number of cardiovascular deaths
Time frame: 24 months
number of hospitalizations for heart failure
Time frame: 24 months
number of surgical reinterventions
Time frame: 24 months
success rate of the LBAP technique
Verification of ECG effectiveness criteria: for the LBAP group: qR or rsR' appearance and for the RVP group: QS or rS aspect
Time frame: 3, 12, and 24 months post-implantation
comparison of immediate and long-term complications of the LBAP stimulation
Adverse events such as: pneumothorax, infection of equipment, displacement of atrial catheter, lumen haematoma, venous thrombosis, pericardial effusion, reoperation, vascular complication, catheter-specific complications
Time frame: 3, 12, and 24 months post-implantation
ECG measurements
QRS duration (ms)
Time frame: 3, 12, and 24 months post-implantation
left ventricular function (LVEF)
Time frame: 3, 12, and 24 months post-implantation
left ventricular diameter
Time frame: 3, 12, and 24 months post-implantation
creatinine levels
Time frame: 3, 12, and 24 months post-implantation
GFR in CKD EPI
Time frame: 3, 12, and 24 months post-implantation
Comparison of the occurrence of atrial fibrillation and ventricular tachycardia (non-sustained or sustained), based on pacemaker monitoring data.
Time frame: 3, 12, and 24 months post-implantation
EQ-5D-5L questionnaire.
Time frame: Baseline (inclusion), 3, 12, and 24 months post-treatment
Evaluate the cost-effectiveness of left bundle branch area pacing versus standard therapy in this population using a cost-utility analysis.
This will be calculated from EQ-5D-5L utility scores.
Time frame: 24 months post-implantation
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