AV node ablation with left bundle branch area pacing versus right ventricular pacing for atrial fibrillation with preserved heart function

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 is a prospective, multicenter, randomized, single-blind comparison of left bundle branch area (LBBA) pacing versus conventional right ventricular (RV) pacing following AV node ablation. The trial's primary outcome is pacing-induced cardiomyopathy, defined as a drop in LVEF of ≥10% to an absolute value below 50%. Secondary outcomes include procedural safety, quality of life, and functional capacity. Eligible patients are adults with symptomatic atrial fibrillation and preserved LVEF (≥50%) who have AV node ablation scheduled independently of study participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. History of symptomatic AF (EHRA IIb - IV) despite guideline-indicated medical or interventional therapy
2. Preserved LVEF (≥ 50%, assessed by echocardiography, Simpson's biplane method)
3. AV node ablation scheduled independently of possible study participation
4. Age ≥ 18 years
5. Consent capacity

Exclusion Criteria:

1. Impaired LVEF (\< 50%)
2. Pre-implanted pacemaker
3. Contraindication for pacemaker implantation or AV node ablation (see chapter 5.3 for details)
4. High grade (III°) left cardiac valvular disease
5. Surgical coronary revascularization (within the last 30 days) or current triple therapy after stent PCI
6. Body-mass-index \> 40 kg/m2
7. Pregnancy
8. Inability to give written informed consent
9. Life expectancy \< 12 months

Where it's running

• St. Josefs-Hospital Wiesbaden GmbH
  Wiesbaden, Germany Recruiting
• Evangelisches Krankenhaus Hagen-Haspe
  Hagen, Germany Not yet recruiting

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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.