ationwide Observational Study for Persistent Atrial Fibrillation Patients with Treatment by SATAKE-HotBalloon Catheter
Not Applicable
Recruiting
- Conditions
- Drug-resistant recurrent symptomatic persistent atrial fibrillation
- Registration Number
- JPRN-jRCT1032230149
- Lead Sponsor
- Yamane Teiichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
1. Patients over the age of 18
2. Patients scheduled for ablation with SATAKE-HotBalloon catheter for persistent atrial fibrillation
Exclusion Criteria
1. Patients diagnosed with a life expectancy of less than 1 year due to some disease
2. Patients who requested refusal regarding the use of information in this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12 months postoperative success rate (Including touch-up cases)
- Secondary Outcome Measures
Name Time Method 1. Acute phase success rate (including touch-up cases)<br> Percentage of study subjects with isolated pulmonary veins (RSPV, RIPV, LSPV, LIPV)<br> Isolated lungs for ablated pulmonary veins (RSPV, RIPV, LSPV, LIPV) Percentage of veins<br><br>Success or failure of isolation: Successful if the potential is 0.1 mV or less or if the pulmonary vein potential and the left atrial potential are not synchronized.<br><br>2. 12 months postoperative safety<br> Occurrence of all adverse events related to catheter ablation during the observation period