Catheter Ablation in Asymptomatic Patients with Atrial Fibrillation

JRCT ID: jRCT1052200120

Registered date:25/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: atrial fibrillation
• Date of first enrollment: 25/01/2021
• Target sample size: 130
• Study type: Interventional

Intervention(s)

intervention g roup: catheter ablation of asymptomatic atrial fibrillation
control group: no catheter ablation of asymptomatic atrial fibrillation

Outcome(s)

• Primary Outcome: BNP 12 months after

Secondary Outcome

efficacy
1. BNP: 3, 6 months, 2, 3, and 5 years after
2. exercise tolerability: 12 months, 2, 3, 5 years after
3. Cr, CCr, eGFR, cystatin C, urine Na, urine Cr: 3, 6, 12 months, 2, 3, 5 years after
4. left ventricular ejection fraction, left atrial dimension, and left atrial volume: 12 months, 2, 3, 5 years after
5. recurrence rate of atrial tachyarrhythmia, cardiovascular events, total death, death related to cardiovascular events: 6, 12 months, 2, 3, 5 years after
6. success rate of pulmonary vein isolation, total procedure time, left atrial dwelling time, radiation exposure time and dose
7. brain MRI: 1, 3, 5 years after
8. AFEQT and MoCA: 1, 3, 5 years after
safery
1. complication and/or side effect of ablation and/or medication

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. aged 20-85 years old
2. asymptomatic atrial fibrillation
3. written informed consent

Exclude criteria

1. previous history of catheter ablation and/or surgery of atrial fibrillation
2. left atrial dimension more than 55 mm
3. BNP equal or less than 20pg/ml
4. eGFR less than 30ml/min/1.73m2
5. patients receiving ARNI
6. pregnant
7. concomittant participation in other medication and/or medical instrument
8. patients whom doctors responsible for this study judge inappropriate

Related Information

• Primary Sponsor: Kusano Kengo
• Source(s) of Monetary Support: Takeda Science Foundation