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LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy

RECRUITINGN/ASponsored by Azienda Ospedaliero Universitaria Maggiore della Carita
Actively Recruiting
PhaseN/A
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita
Started2023-06-10
Est. completion2025-06-10
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05910866

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions6

BradycardiaCardiac Remodeling, VentricularConduction Block, AtrioventricularHeart DiseaseHeart FailurePacemaker-Induced Cardiomyopathy

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