Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures

Abbott Medical Devices269 enrolled

Overview

A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.

The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat AF ablation procedures. This study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

269

Conditions

Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation

Interventions

Standard PVIPROCEDURE

Standard PVI procedure without FIRMap.

FIRM-Guided Procedure and PVIPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Experiencing at least one (1) documented episode of spontaneous persistent or paroxysmal atrial fibrillation during the last 3 months by rhythm strip/ECG. * One (1) previous AF ablation (PVI-only - any technology) after Jan-01-2013, but NOT within the last 3 months. * Left atrial diameter \< 6.0 cm via transthoracic echo or transesophageal echo; or \<6.5 cm via CT or MRI with 6 months prior to the procedure. * Sustained spontaneous or induced AF (\>5 min uninterrupted). Exclusion Criteria: * Presence of structural heart disease with clinical significance * NYHA Class IV * Ejection fraction \< 35% * Previous AF ablation within the last 3 months * ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker. * History of myocardial infarction (MI) within the past three (3) months * Atrial clot/thrombus noted within 72 hours of the procedure

Locations (24)

Arizona Heart Rhythm Research Cente

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure.

Single procedure freedom from recurrence from 3-12 months post procedure

Time frame: 12 months post procedure

Freedom From Serious Adverse Events Related to the Procedure

Freedom from any procedure-related serious adverse event from 0-10 days post procedure

Time frame: 10-day post procedure

Freedom From Serious Adverse Events Related to the Procedure

Freedom from any procedure-related serious adverse event from 0-12 months post procedure

Time frame: 12-month post procedure

Data from ClinicalTrials.gov

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