AV node ablation with left bundle branch area pacing versus right ventricular pacing for atrial fibrillation with preserved heart function
AtrioVentricular Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function - a Randomized Controlled Trial
This test checks whether left bundle branch area (LBBA) pacing instead of right ventricular (RV) pacing after AV node ablation better preserves heart function in adults with symptomatic atrial fibrillation and normal ejection fraction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Josefs-Hospital Wiesbaden GmbH Academic / other |
| Locations | 2 sites (Hagen and 1 other locations) |
| Trial ID | NCT07428967 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with symptomatic atrial fibrillation, preserved LVEF (≥50%), and an AV node ablation planned may be eligible.
Not a fit: Patients with LVEF <50%, an existing pacemaker, contraindications to pacemaker implantation or AV node ablation, recent major cardiac surgery, pregnancy, BMI >40, or life expectancy under 12 months are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, LBBA pacing could reduce the risk of pacing-induced cardiomyopathy and better preserve left ventricular function after AV node ablation.
How similar studies have performed: Early observational and small randomized reports of conduction system pacing (His-bundle and left bundle branch area pacing) suggest reduced pacing-related dysfunction compared with RV pacing, but high-quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hagen and 1 other locations
- Evangelisches Krankenhaus Hagen-Haspe — Hagen, Germany (Not_yet_recruiting)
- St. Josefs-Hospital Wiesbaden GmbH — Wiesbaden, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.