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

NCT01925885 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-04-05

No results posted yet for this study

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.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • John M Miller, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-12-23
Completion
2015-12-23

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01925885 on ClinicalTrials.gov