RecruitingNot ApplicableNCT05015660

Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing

LEFT Bundle Pacing vs Standard Right Ventricular Pacing for Heart Failure


Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

1,300 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF). High percentage ventricular pacing and wider paced QRS in the setting of normal baseline LV ejection fractions have consistently been shown to be independent risk factors for pacing-induced cardiomyopathy. Left bundle branch pacing (LBBP) has emerged as a potential alternative pacing mechanism that may avoid LV dyssynchrony and pacing-induced LV dysfunction by mimicking native electrical conduction.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two ways of placing a pacemaker in people with heart block (where signals between the heart's upper and lower chambers are blocked). It compares traditional right ventricle pacing to a newer technique called left bundle branch pacing, which mimics the heart's natural rhythm more closely. **You may be eligible if...** - You are 18 or older - Your heart's pumping strength (ejection fraction) is greater than 35% - You have been diagnosed with high-degree heart block requiring a pacemaker, and your doctor expects you to need pacing more than 90% of the time - You had a recent echocardiogram (heart ultrasound) within the last 3 months - You have third-degree AV block, second-degree AV block, or significant first-degree AV block with symptoms **You may NOT be eligible if...** - Your ejection fraction is 35% or less - You have had a prior pacemaker or defibrillator implanted - You are not expected to require frequent pacing - You have active infection or other conditions making surgery unsafe 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 pacing lead

Implantation of a left bundle branch pacing lead via sheath, to perform selective or non-selective pacing

DEVICERight ventricular active fixation lead

Active fixation lead (standard)


Locations(1)

McGill University Health Centre-Research Institute

Montreal, Quebec, Canada

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NCT05015660


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