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

Atrial Fibrillation Ablation Using a Flexible Tip Catheter with Efficient Irrigation Property -Multicenter, Randomized Controlled Trial with Multiple Output Settings-"

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1032230236

Enrollment

180

Registered

2023-07-15

Start date

2023-07-15

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation atrial fibrillation

Interventions

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 ou

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Ablation time for pulmonary vein isolation.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactKoji Sudo

University of Yamanashi

ksudo@yamanashi.ac.jp+81-55-273-9590

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026