A study on safety and efficacy of atrial fibrillation ablation using ThermoCoolTM SmartTouchTM Surround Flow catheter: comparison with ThermoCool TM SmartTouch TM (thermo cool smart touch) catheter

A study on safety and efficacy of atrial fibrillation ablation using ThermoCoolTM SmartTouchTM Surround Flow catheter: comparison with ThermoCool TM SmartTouch TM (thermo cool smart touch) catheter - Importance of considering the impact of surround flow irrigation to achieve safe and effective contact force-guided circumferential pulmonary vein isolation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025570

Enrollment

Registered

2017-01-30

Start date

2017-01-30

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

atrial fibrillation

Interventions

ThermoCool SmartTouch ThermoCool SmartTouch Surround Flow

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A) Patients who satisfy atrial fibrillation ablation adaptation criteria in Japan B) Patients who can perform electrical defibrillation immediately before ablation treatment, return to sinus rhythm and maintain sinus rhythm C) Patients over 20 years old D) After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding

Exclusion criteria

Exclusion criteria: A) Patients who do not return to sinus rhythm by electrical defibrillation B) Patients who repeat recurrence of atrial fibrillation although returning to sinus rhythm by electrical defibrillation C) Patients with low left ventricular function (left ventricular ejection fraction: 30% or less) or acute heart failure combined D) Patients undergoing dialysis E) Patients judged inappropriate as subjects by doctors F) Patients who are participating in, or are expected to participate in, studies that may affect this study

Design outcomes

Primary

Measure	Time frame
Time (sec) until pacing (rate 120 beats / minute) becomes impossible to capture atrial muscle by radiofrequency ablation	—

Countries

Japan

Contacts

Public ContactNatsumi Nigawara

Hirosaki University Graduate School of Medicine Department of Advance Management of Cardiac Arrhythmias

niga8ra@hirosaki-u.ac.jp0172-39-5144

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026