Pacing and Ablation for Patients with Atrial Fibrillation

Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation

This study is testing whether a combination of a special pacemaker and a procedure to block heart signals can help people with tough-to-treat atrial fibrillation feel better compared to just using medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (Academic / other)
• Locations: 1 site (Seoul, Jongno-gu)
• Trial ID: NCT06699342 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the outcomes of left bundle branch area pacing combined with atrioventricular node ablation against optimized pharmacologic treatment in patients suffering from symptomatic atrial fibrillation who are refractory or intolerant to drug therapy or catheter ablation. It is a multicenter, randomized, open-label trial involving 50 patients, with a 1:1 randomization. The study will assess primary outcomes over 6 months and secondary outcomes over 24 months, focusing on the effectiveness of the interventions. Procedures include pacemaker implantation and ablation techniques tailored to individual patient needs.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65 and older with permanent atrial fibrillation who are refractory or intolerant to standard drug therapies.

Not a fit: Patients with asymptomatic atrial fibrillation or those with a life expectancy of less than 12 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with difficult-to-manage atrial fibrillation.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in managing atrial fibrillation with pacing and ablation techniques.

Eligibility criteria

Inclusion:

Patients who meet all of the following inclusion criteria 1)-6).

1. Permanent atrial fibrillation
2. Age ≥ 65 years
3. Refractory or intolerant to antiarrhythmic drugs, rate control medications, or catheter ablation
4. New York Heart Association (NYHA) functional class II- IV
5. LVEF \> 40% (within the past 3 months)
6. Patients with at least one of the following:

   1. HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting ≥12 hours and including treatment with intravenous (IV) diuretics at a healthcare facility) within 12 months
   2. Elevated NT-proBNP (\>900 pg/ml) in the 30 days prior to enrollment

Exclusion:

Patients who meet at least one of the following exclusion criteria 1)-11).

1. Asymptomatic atrial fibrillation
2. Life expectancy to \< 12 months.
3. Primary moderate to severe valvular disease (except for functional mitral valve regurgitation or tricuspid valve regurgitation)
4. Mechanical tricuspid valve replacement
5. Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 15 ml/1,73 m2 or receiving renal replacement treatment including hemodialysis or peritoneal dialysis)
6. Obstructive hypertrophic cardiomyopathy
7. Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
8. Acute coronary syndrome or coronary revascularization (CABG or PCI) \<3 months
9. Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation
10. Pacemaker/ICD/CRT treatment ongoing, or current pacemaker indication
11. Simultaneous participation in a different randomized clinical trial

Where this trial is running

Seoul, Jongno-gu

• Seoul National University Hospital — Seoul, Jongno-gu, South Korea (Recruiting)

Study contacts

• Study coordinator: Eue-keun Choi, M.D. Ph.D

Conditions Atrial Fibrillation; atrial fibrillation; left bundle branch area pacing; Atrioventricular node ablation