Safety and Efficacy of Radiofrequency Catheter Ablation of Atrial Fibrillation Drivers as Identified by Fractionated Atrial Potentials (FrAP) Mapping, Using the Rhythmia 3-D Mapping System in Patients with Recurrent Atrial Fibrillation After Prior Pulmonary Vein Isolation Procedure
Not Applicable
- Conditions
- atrial fibrillation
- Registration Number
- JPRN-UMIN000044793
- Lead Sponsor
- Toyohashi Heart Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
1)Initial procedure failed to isolate one or more PVs 2)Left atrial size > 6.1 cm (Anterior-Posterior Dimension) 3)LVEF <35 % 4)Severe mitral regurgitation 5)Prior mitral valve surgery with mechanical valve replacement 6)Intracardiac thrombus present on pre-procedure TTE, TEE. or CT 7)Preexisting severe pulmonary vein stenosis (>75% narrowing) 8)Comorbidity with life-expectancy < 2 years 9)Unable to be on anticoagulation for the purpose of stroke prevention 10)Untreated thyroild dysfunction 11)End-stage renal disease (eGFR<15 or requirement of hemodialysis)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from atrial fibrillation, atrial flutter or atrial tachycardia during 1-year after catheter ablation procedure.
- Secondary Outcome Measures
Name Time Method