ConditionsBradycardiaHeart FailurePacemaker-Induced CardiomyopathyConduction Block, AtrioventricularCardiac Remodeling, Ventricular
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita
About this trial
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 criteria
Qualifiers
advanced AVB (frequent 2° degree or 3° degree AVB, atrial fibrillation - AF - with advanced AV block) and preserved or slightly reduced LVEF (>45%)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Left bundle branch area pacing (LBBAP)
- Right ventricular pacing (RVP)
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov