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

JRCT ID: jRCT1032230236

Registered date:15/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 15/07/2023
• Target sample size: 180
• Study type: Interventional

Intervention(s)

In this study, a three-dimensional mapping system (EnSite X system) will be used, and pulmonary vein isolation procedures will be performed using a flexible tip catheter (TactiFlex, Abbott) in each output group (30W group, 40W group, 50W group) assigned randomly.

The intervention protocols for each group are as follows:
30W group: The output will be set to 30W, and energy delivery will be applied for a maximum of 50 seconds.
40W group: The output will be set to 40W, and energy delivery will be applied for a maximum of 20 seconds.
50W group: The output will be set to 50W, and energy delivery will be applied for a maximum of 10 seconds.

Outcome(s)

• Primary Outcome: Ablation time for pulmonary vein isolation.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kuroki Kenji