LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy (NCT05910866) | Clinical Trial Compass
UnknownNot Applicable
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy
Italy130 participantsStarted 2023-06-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* advanced AVB (frequent 2° degree or 3° degree AVB, atrial fibrillation - AF - with advanced AV block) and preserved or slightly reduced LVEF (\>45%)
Exclusion Criteria:
* LVEF ≤45%
* signs or symptoms of heart failure at enrollment
* unstable angina or acute coronary syndrome \<3 months
* percutaneous coronary intervention or coronary-artery bypass surgery \<3 months
* life expectancy \<6 months
* previous hospitalization for heart failure
* evidence of pulmonary artery hypertension of any origin
* valvular disease greater than moderate
* previous heart transplant pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute and relative value of LVEF (left ventricular ejection fraction) difference between two arms at follow-up
Timeframe: 1 year
Trial details
NCT IDNCT05910866
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita