๐ฌIn plain words
What the trial is, and whether it could suit you
This study aimed to compare the clinical outcomes of left bundle branch area pacing combined with atrioventricular node ablation and pharmacologic treatment optimized according to guidelines in patients with symptomatic atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion:
Patients who meet all of the following inclusion criteria 1)-6).
1. Permanent atrial fibrillation
2. Age โฅ 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 โฅ12 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 โค 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
๐
What it tests
- Pacemaker implantation with Left bundle branch area pacing (LBBAP)
- Atrioventricular node ablation (AVNA)
- Pharmacologic therapy optimized for Atrial Fibrillation management
Seoul National University Hospital
Seoul, South Korea
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.