RecruitingNot ApplicableNCT05910866

LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy

LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy: the LEAP-CAR Prospective, Randomized Trial


Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Enrollment

130 participants

Start Date

Jun 10, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a newer type of pacemaker lead placement called left bundle branch area pacing (LBBAP) — which mimics the heart's natural electrical system more closely — versus traditional right ventricular pacing in people who need a pacemaker. The goal is to see whether LBBAP prevents the heart muscle weakening that can happen over time with conventional pacing. **You may be eligible if...** - You have an advanced heart block (a condition where electrical signals from the upper to lower heart are blocked — either frequent 2nd degree or complete 3rd degree) or atrial fibrillation with a very slow heart rate - Your heart's pumping function is preserved or only mildly reduced (left ventricular ejection fraction above 45%) **You may NOT be eligible if...** - Your heart's pumping function is already significantly reduced (ejection fraction 45% or below) - You have symptoms of heart failure - You had a heart attack, unstable chest pain, or coronary intervention within the past 3 months - You have a life expectancy of less than 6 months - You have been hospitalized for heart failure in the past - You have significant pulmonary artery high blood pressure or moderate-to-severe valve disease - You are pregnant or have had a prior heart transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELeft bundle branch area pacing (LBBAP)

Pacing of the conduction system of the heart to obtain physiological activation

DEVICERight ventricular pacing (RVP)

Conventional ventricular pacing


Locations(1)

Hospital "Maggiore della Carità", Division of Cardiology

Novara, Italy

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NCT05910866


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