A Multicenter Prospective Randomized Interventional Study Examining the Impact of Wide Interlesion Distance in High Power Short Duration Atrial Fibrillation Ablation Using the TactiFlex

JRCT ID: jRCT1042230052

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 17/10/2023
• Target sample size: 204
• Study type: Interventional
• Intervention(s): Allocation of catheter ablation treatment method for atrial fibrillation (5mm tag group and 7mm tag group).

Outcome(s)

Primary Outcome

Initial Success Rate of Pulmonary Vein Isolation Line
Initial success of pulmonary vein isolation line is defined as when either of the following two conditions is met
1: Successful first pass isolation and no premature re-conduction of the pulmonary vein at least 30 minutes after pulmonary vein isolation.
2: When the failure of first pass isolation and early re-conduction is due solely to early excitation in the pulmonary vein by epicardial conduction and the pulmonary vein isolation line is evaluated to be complete.
The left and right pulmonary veins will be evaluated separately for each subject in the study.

Secondary Outcome

Success rate of first pass isolation
Early nonreconduction rate
Number of cauterizations
Cauterization time
Procedure time
Fluoroscopy time
Ablation-related complications

Key inclusion & exclusion criteria

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

Include criteria

1. patients between 20 and 80 years of age
2. patients diagnosed with paroxysmal atrial fibrillation and scheduled for first catheter ablation procedure (using TactiFlex)
3. Patients who have given their consent to participate in this study by signing a consent form in person.

Exclude criteria

Patients who meet any of the following criteria will not be included in this study
1. Patients with a history of catheter ablation for atrial fibrillation
2. Patients with serious renal disease (on hemodialysis)
3. women who are lactating, pregnant, or of childbearing potential
4. patients with symptomatic heart failure (NYHA III degree or higher).

Related Information

• Primary Sponsor: Naruse Yoshihisa