An interventional study of Left bundle branch area pacing with pacemaker and Implantation loop recorder in TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block and Reduced Left Ventricular Ejection Fraction, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment
Patients with new-onset complete LBBB (QRS > 120 ms, persisting > 24 h after TAVI) and moderately reduced LVEF (35-50%) will be screened in participating centers.
Eligible patients will be centrally randomized 1:1 (stratified by center and atrial fibrillation (yes/no)) to either:
The occurrence of the following events within 12 months of randomization will be evaluated: hospitalization for heart failure, syncope or hemodynamically significant dizziness, or high-grade atrioventricular conduction disturbance.
The impact of LBB(AP) compared to ILR monitoring will be evaluated at 6, 12, 24, and 36 months regarding: incidence of atrial fibrillation; incidence of non-sustained ventricular tachycardia; evolution of left ventricular ejection fraction; quality of life; hospitalizations; mortality; medico-economic outcomes; qccurrence of high-grade AV conduction disorders beyond 12 months; omplications related to pacemaker or ILR implantation; unscheduled pacemaker implantation in the ILR group.
Patients will be monitored following a regular schedule that includes clinical visits, transthoracic echocardiography , ECG, remote device monitoring, and EQ-5D at 6, 12, 24 and 36 months.
92 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's planned enrollment of 700 is above the median of 60 across 57 interventional studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →University Hospital, Clermont-Ferrand is the lead sponsor of 856 studies on the registry; 180 are open to participants now.
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Exclusion Criteria:
Procedure: Left bundle branch area pacing with pacemaker
Control arm
Procedure: Implantation loop recorder
LBB(AP) procedure will be performed by experienced operators according international guidelines and expert consensus. The implantation technique will be those used routinely in these expert centers. The procedure will begin with a vein access (axillary, sub-clavian or cephalic). The atrial, if necessary, will be implanted as usual practice. LBB(AP) lead will be implanted as recommended. LBB(AP) positioning criteria, as described in reference clinical studies, will be checked in order to differentiate between LBB(AP) and deep septal pacing.
ILR Procedure will be performed by experienced operators according international guidelines and expert consensus. The implantation technique will be those used routinely in these expert centers. The implanted device will be a Biomonitor IV (Biotronik, Berlin, Germany) and next generation if necessary. The implantable Loop Recorder is a single-lead ECG monitor of small size with long-term functionality (approximately 3 to 5 years). It is implanted under local anesthesia in the subcutaneous space of the left thoracic region (incision at the level of the 4th left intercostal space at a 45° angle).
The first occurrence of one of the following events : hospitalization for worsening heart failure, episode of syncope or dizziness, high-grade atrioventricular conduction disturbance)
The primary efficacy endpoint is a composite clinical outcome evaluated at 12 months after randomization, defined as the first occurrence of one of the following events: 1. Hospitalization for worsening heart failure, 2. Episode of syncope or dizziness, 3. High-grade atrioventricular conduction disturbance (second-degree AV block type II or third-degree AV block requiring implantation of a permanent pacemaker, documented \> 3 seconds on ILR or ECG)). The composite endpoint will be analyzed as time-to-event data with death considered as a competing risk.
Time frame: From randomization to 12 follow up
Incidence of atrial fibrillation, ventricular tachycardia, non-sustained ventricular tachycardia
Time frame: At 6,12, 24 and 36 months after randomization
Evolution of LVEF
Measurement of LVEF at inclusion and at each follow-up time point. The change in LVEF over time will be assessed relative to the date of inclusion and the preceding time point.
Time frame: At 6,12, 24 and 36 months after randomization
Evolution of Quality of life (EQ-5D)
Measurement of EQ-5D at inclusion and at each follow-up time point. The change in EQ-5D over time will be assessed relative to the date of inclusion and the preceding time point.
Time frame: At 6, 12, 24 and 36 months after randomization
Incidence of Hospitalizations (all-cause, cardiovascular, HF-related)
Time frame: At 6, 12, 24 and 36 months after randomization
Incidence of Mortality (all-cause, cardiovascular, HF-related)
Measurement of the cumulative incidence of all-cause, cardiovascular, and heart failure-related mortality at 6, 12, 24, and 36 months after randomization, based on the occurrence and documented cause of death.
Time frame: At 6, 12, 24 and 36 months after randomization
Medico-economic evaluation
Time frame: At 6, 12, 24 and 36 months after randomization
Complications related to pacemaker or ILR implantation
Time frame: At 6, 12, 24 and 36 months after randomization
Unscheduled pacemaker implantation in the ILR group
Time frame: At 6, 12, 24 and 36 months after randomization
Plan to share: Yes
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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