JRCT ID: jRCT1052200120
Registered date:25/01/2021
Catheter Ablation in Asymptomatic Patients with Atrial Fibrillation
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 |
Countries of recruitment | |
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 |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | Takeda Science Foundation |
Secondary ID(s) |
Contact
Public contact | |
Name | Koji Miyamoto |
Address | 6-1, Kishibeshinmachi, Suita, Osaka Osaka Japan 564-8565 |
Telephone | +81-6-6170-1070 |
koji3koji3@gmail.com | |
Affiliation | National Cerebral and Cardiovascular Center |
Scientific contact | |
Name | Kengo Kusano |
Address | 6-1, Kishibeshinmachi, Suita, Osaka Osaka Japan 564-8565 |
Telephone | +81-6-6170-1070 |
kusanokengo@gmail.com | |
Affiliation | National Cerebral and Cardiovascular Center |