Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures (REDO-FIRM)

Abbott

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Procedure: FIRM-Guided Procedure and PVI; Procedure: Standard PVI

Study type: Interventional

Funder types: Industry

Identifiers

NCT02799043

REDO-FIRM

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 269 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

269 participants in 2 patient groups

Standard PVI

Active Comparator group

Description:

Standard catheter ablation including pulmonary vein isolation (PVI) procedure.

Treatment:

Procedure: Standard PVI

FIRM-guided Procedure and PVI

Experimental group

Description:

FIRM-guided procedure followed by PVI.

Treatment:

Procedure: FIRM-Guided Procedure and PVI