RecruitingNot ApplicableNCT06620705

Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction

Pacing Away from Heart Failure: Left Bundle Branch Area Pacing or Biventricular Pacing in Patients with Atrial Fibrillation and Left Ventricular Dysfunction


Sponsor

srdpiers

Enrollment

34 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of heart pacing devices in people with a permanent irregular heart rhythm (atrial fibrillation) and a weakened heart. Researchers want to know whether a newer pacing technique called left bundle branch area pacing (LBBAP) works as well as or better than the traditional biventricular pacing (CRT) for improving heart function. **You may be eligible if...** - You are 18 or older - You have permanent atrial fibrillation and a heart pumping function below 50% - You need a pacemaker due to a slow heart rate, or you qualify for cardiac resynchronization therapy - Your heart rate pacing is expected to exceed 40% of the time - You have been on heart failure medications for at least 3 months - You already have a device but need an upgrade to a resynchronization device **You may NOT be eligible if...** - You are under 18 - You are pregnant or trying to become pregnant - A lead cannot be safely implanted in the required heart chambers - You had heart valve surgery or a heart attack within the past 6 months - You have the most severe class of heart failure (NYHA class IV), a heart assist device, or are awaiting a 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

Pacing of the left bundle branch area using a transvenous pacemaker lead

DEVICEBiventricular pacing

Pacing of the right and left ventricle using transvenous pacemaker leads


Locations(2)

Aarhus University Hospital

Aarhus N, Aarhus N, Denmark

Leiden University Medical Center

Leiden, South Holland, Netherlands

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NCT06620705


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