Using left bundle branch area pacing to prevent heart issues from pacemakers
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy: the LEAP-CAR Prospective, Randomized Trial
This study tests if a new way of pacing the heart called left bundle branch area pacing can help people with slow heartbeats avoid heart problems that can come from traditional pacemakers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita Academic / other |
| Locations | 1 site (Novara) |
| Trial ID | NCT05910866 on ClinicalTrials.gov |
What this trial studies
LEAP-CAR evaluates the effectiveness of left bundle branch area pacing (LBBAP) compared to conventional right ventricular pacing (RVP) in preventing pacing-induced cardiomyopathy (PICM) in patients with advanced atrioventricular block and preserved left ventricular ejection fraction. This randomized, prospective, double-blind clinical trial aims to determine if LBBAP can maintain normal heart function and reduce the incidence of heart failure associated with traditional pacing methods. The study focuses on patients who require pacemakers for bradycardia and have a baseline left ventricular ejection fraction greater than 45%.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced atrioventricular block and preserved left ventricular ejection fraction greater than 45%.
Not a fit: Patients with left ventricular ejection fraction of 45% or lower, signs of heart failure, or other significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of heart failure and improve the quality of life for patients requiring pacemakers.
How similar studies have performed: While LBBAP is a novel approach, preliminary evidence suggests it may be more effective than traditional methods, although further studies are needed to confirm its benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Novara
- Hospital "Maggiore della Carità", Division of Cardiology — Novara, Italy (Recruiting)
Study contacts
- Study coordinator: Gabriele Dell'Era, MD
- Email: gabriele.dellera@maggioreosp.novara.it
- Phone: 03213733294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.