Clinical Research Directory
Browse clinical research sites, groups, and studies.
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
Sponsor: University Hospital, Clermont-Ferrand
Summary
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: * Experimental arm: Left bundle branch area pacing (LBB(AP)) with Biotronik pacemaker and dedicated conduction system pacing leads. * Control arm: Implantable loop recorder (ILR, Biotronik BIOMONITOR IV) for rhythm monitoring. 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.
Official title: Comparison of Left Bundle Branch Area Pacing (LBB(AP)) and Implantable Loop Recorder (ILR) in Patients With New-onset Left Bundle Branch Block and Moderately Reduced LVEF After Transcatheter Aortic Valve Implantation (TAVI): A Randomized Multicenter Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2026-10-15
Completion Date
2034-10-15
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Left bundle branch area pacing with pacemaker
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.
Implantation loop recorder
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).
Locations (1)
Chu Clermont Ferrand
Clermont-Ferrand, France