FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of PAF (FIRMAP-AF)

The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided RF ablation procedures for the treatment of symptomatic paroxysmal atrial fibrillation. The subjects will be blinded to study treatment for the duration of the study period.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Focal Impulse and Rotor Modulation Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation
Estimated Enrollment: 170
Study Start Date: February 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Arms:
- Experimental: FIRM-only
- Active Comparator: Conventional