RecruitingNot 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 range18 Years

SexALL

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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

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-10

Contact for this trial

Gabriele Dell'Era, MD

03213733294 gabriele.dellera@maggioreosp.novara.it

View on ClinicalTrials.gov More Bradycardia trials