LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy: the LEAP-CAR Prospective, Randomized Trial
Azienda Ospedaliero Universitaria Maggiore della Carita
130 participants
Jun 10, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- advanced AVB (frequent 2° degree or 3° degree AVB, atrial fibrillation - AF - with advanced AV block) and preserved or slightly reduced LVEF (\>45%)
Exclusion Criteria9
- 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
Interventions
Pacing of the conduction system of the heart to obtain physiological activation
Conventional ventricular pacing
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05910866