NCT01925885

Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

* 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.

Detailed description

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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	PVI Ablation	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.
PROCEDURE	FIRM Ablation	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

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-12-23
• Completion: 2015-12-23
• First posted: 2013-08-20
• Last updated: 2017-04-05

Locations

1 site across 1 country: United States