Atrial Fibrillation Ablation Using a Flexible Tip Catheter with Multiple Output Settings

Not Applicable

Recruiting

• Conditions: Atrial fibrillation; atrial fibrillation

• Registration Number: JPRN-jRCT1032230236
• Lead Sponsor: Kuroki Kenji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Patients who have been diagnosed with non-valvular atrial fibrillation, who is eligible for catheter ablation, and who can be followed up at the outpatient clinic.
2. Patients who are aged 20 or older and under 80 at the time of obtaining consent (regardless of gender).
3. Patients who provided written consent based on their own free will as research subjects, after receiving sufficient explanation regarding participation in this study.

Exclusion Criteria

1. Patients who are contraindicated for antiplatelet therapy or anticoagulant therapy.
2. Patients who have been definitively diagnosed with mitral valve stenosis.
3. Patients who have an implanted artificial valve.
4. Patients who have undergone ventricular or atrial incision surgery within the past 4 weeks.
5. Patients diagnosed with a life expectancy of less than one year due to any illness.
6. Patients with left atrial thrombus.
7. Patients with a left atrial diameter exceeding 50mm.
8. Patients with a history of catheter ablation.
9. Patients with thyroid dysfunction.
10. Patients with cancer.
11. Patients with reduced cardiac function and a left ventricular ejection fraction of less than 50%.
12. Patients with atrial fibrillation persisting for more than 5 years.
13. Patients with atrial fibrillation associated with hypertrophic or dilated cardiomyopathy.
14. Patients with atrial fibrillation and renal dysfunction (eGFR less than 50 mL/min/1.73m2).
15. Pregnant patients.
16. Other patients deemed unsuitable for research participation by the investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ablation time for pulmonary vein isolation.

Secondary Outcome Measures

Name	Time	Method
1) Total procedure time for pulmonary vein isolation.<br>2) Pulmonary vein isolation rate on the first pass.<br>3) Ablation-related complications for each output setting.<br>4) Arrhythmia recurrence during the one-year follow-up period.