LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy: the LEAP-CAR Prospective, Randomized Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant for advanced (2° or 3° degree) atrioventricular block, with baseline left ventricular ejection fraction (LVEF) \>45%. LEAP-CAR is a randomized, prospective, double blind clinical trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• advanced AVB (frequent 2° degree or 3° degree AVB, atrial fibrillation - AF - with advanced AV block) and preserved or slightly reduced LVEF (\>45%)
Locations
Other Locations
Italy
Hospital Maggiore della Carità, Division of Cardiology
RECRUITING
Novara
Contact Information
Primary
Gabriele Dell'Era, MD
gabriele.dellera@maggioreosp.novara.it
03213733294
Backup
Chiara Ghiglieno, MD
chiara.ghiglieno@maggioreosp.novara.it
03213733294
Time Frame
Start Date: 2023-06-10
Estimated Completion Date: 2026-06-10
Participants
Target number of participants: 130
Treatments
Experimental: Left bundle branch area pacing (LBBAP)
Implant of the ventricular lead of the pacemaker in the left bundle branch area
Active_comparator: Right ventricular pacing (RVP)
Implant of the ventricular lead of the pacemaker in a conventional site for pacing (apex/paraapical interventricular septum)
Related Therapeutic Areas
Sponsors
Leads: Azienda Ospedaliero Universitaria Maggiore della Carita