Comparing two pacing methods for heart failure in patients with atrial fibrillation

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

This study is testing whether a new pacing method for the heart can work better than the standard method for people with heart failure and atrial fibrillation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Locations: 2 sites (Aarhus N, Aarhus N and 1 other locations)
• Trial ID: NCT06620705 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine whether left bundle branch area pacing (LBBAP) or biventricular pacing is more effective in preventing or reversing left ventricular adverse remodeling in patients with atrial fibrillation (AF) and left ventricular dysfunction. It is a randomized, non-inferiority crossover trial where participants will receive both pacing methods in a sequential manner. The primary objective is to compare changes in left ventricular end-systolic volume, while secondary objectives include assessing quality of life, functional capacity, and various cardiac metrics. The study population consists of adults with permanent AF and reduced left ventricular ejection fraction who require ventricular pacing.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with permanent atrial fibrillation and left ventricular ejection fraction less than 50% who require ventricular pacing.

Not a fit: Patients with NYHA functional class IV heart failure or those not eligible for lead implantation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective pacing strategy for improving heart function in patients with atrial fibrillation and heart failure.

How similar studies have performed: While the specific comparison of LBBAP and biventricular pacing is novel, similar studies have shown promising results with both pacing techniques in improving heart function.

Eligibility criteria

INCLUSION CRITERIA

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Adults ≥18 years with permanent AF and LVEF \< 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy.
* Expected percentage of ventricular pacing \> 40%
* ≥ 3 months of heart failure medication optimization

Of note, patients who already have a device, but require an upgrade to a CRT device, can also be included

EXCLUSION CRITERIA

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Age \< 18 years
* Pregnancy or active pregnancy wish
* Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus
* Recent valve intervention/surgery or acute myocardial infarction (\< 6 months)
* NYHA functional class IV heart failure, left ventricular assist device or cardiac transplant

Where this trial is running

Aarhus N, Aarhus N and 1 other locations

• Aarhus University Hospital — Aarhus N, Aarhus N, Denmark (Not_yet_recruiting)
• Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Sebastiaan Piers, MD, PhD — Leiden University Medical Center, Leiden, the Netherlands
• Study coordinator: Sebastiaan RD Piers, MD, PhD

Conditions Heart Failure; Block, Heart; Pacing-Induced Cardiomyopathy; pacing; cardiac resynchronization therapy; left bundle branch area pacing; conduction system pacing; heart failure