* Hypothesis: Focal Impulse and Rotor Modulation (FIRM) will substantially reduce or eliminate clinical atrial fibrillation in subjects with accepted indications for catheter ablation of paroxysmal AF, compared to standard pulmonary vein isolation. * Summary: This is a prospective randomized study to assess the safety and effectiveness of FIRM procedures only, versus standard Pulmonary Vein Isolation (PVI) procedures for the treatment of symptomatic paroxysmal atrial fibrillation.
A total of 188 subjects will be enrolled-subjects will be equally (1:1) randomized between those undergoing conventional atrial fibrillation ablation with confirmation of pulmonary vein isolation (PVI) versus those actively treated with the FIRM procedure without PVI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1
PVI ablation for atrial fibrillation specifically targets areas in the left atrium in the area just outside the pulmonary veins to eliminate triggers of atrial fibrillation.
Ablation for atrial fibrillation specifically targets areas in the left or right atrium to eliminate areas that maintain atrial fibrillation without isolating the pulmonary veins
Indiana University
Indianapolis, Indiana, United States
Acute Ablation Success for Paroxysmal Atrial Fibrillation
* the termination of spontaneous or induced atrial fibrillation by ablation at an atrial fibrillation source arrhythmia location * the slowing of the mean atrial fibrillation rate at least by 10% by ablation at an atrial fibrillation source arrhythmia * evaluate safety and effectiveness of the FIRM procedures for the treatment of paroxysmal atrial fibrillation * freedom from major adverse events related to the procedure within 7 days of the procedure
Time frame: 1 week
Long Term Ablation Success for Paroxysmal Atrial Fibrillation
* freedom from atrial fibrillation recurrence (\>30sec) from 3-12 months * freedom from major adverse events related to the procedure within one year of the procedure
Time frame: 1 year
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