Pacing and Ablation for 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 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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Eue-keun Choi, M.D. Ph.D
• Email: choiek417@gmail.com
• Phone: 82-2-2072-0688

Similar studies

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

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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.