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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Leiden University Medical Center
  Leiden, South Holland, Netherlands Recruiting
• Aarhus University Hospital
  Aarhus N, Aarhus N, Denmark Not yet recruiting

Study contacts

• Principal investigator: Sebastiaan Piers, MD, PhD — Leiden University Medical Center, Leiden, the Netherlands
• Study coordinator: Sebastiaan RD Piers, MD, PhD
• Email: s.r.d.piers@lumc.nl
• Phone: +31715262020

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing His and Left Bundle Branch Pacing for Heart Failure

  This study is testing whether a new way of pacing the heart can help people with heart failure feel better and stay out of the hospital compared to the usual treatment.

  Recruiting at 62 sites Baylor College of Medicine · Gilbert, Arizona and 70 other locations · NCT05650658

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.