A Multicenter Prospective Randomized Interventional Study Examining the Impact of Wide Interlesion Distance in High Power Short Duration Atrial Fibrillation Ablation Using the TactiFlex
Not Applicable
Recruiting
- Conditions
- Atrial fibrillationAtrial fibrillation, ablation, interlesion distanceD001281
- Registration Number
- JPRN-jRCT1042230052
- Lead Sponsor
- aruse Yoshihisa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 204
Inclusion 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.
Exclusion 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Initial Success Rate of Pulmonary Vein Isolation Line<br>Initial success of pulmonary vein isolation line is defined as when either of the following two conditions is met<br>1: Successful first pass isolation and no premature re-conduction of the pulmonary vein at least 30 minutes after pulmonary vein isolation.<br>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.<br>The left and right pulmonary veins will be evaluated separately for each subject in the study.
- Secondary Outcome Measures
Name Time Method Success rate of first pass isolation<br>Early nonreconduction rate<br>Number of cauterizations<br>Cauterization time<br>Procedure time<br>Fluoroscopy time<br>Ablation-related complications