NCT02799043

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

Official Title:

Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Persistent Atrial Fibrillation

Paroxysmal Atrial Fibrillation

Primary Purpose
  • DIAGNOSTIC
Intervention/Treatment
    • Type: PROCEDURE
    • Name: Standard PVI
    • Description: Standard PVI procedure without FIRMap.
    • Arm Group Labels: Standard PVI
    • Type: PROCEDURE
    • Name: FIRM-Guided Procedure and PVI
    • Description:
    • Arm Group Labels: FIRM-guided Procedure and PVI
Sponsor
  • Abbott Medical Devices