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

Status:	Recruiting
Conditions:	Atrial Fibrillation
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 80
Updated:	2/1/2019
Start Date:	June 2016
End Date:	December 2020
Contact:	Study Lead
Email:	nirvi.mistry@abbott.com

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

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.

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

We found this trial at

sites

Johns Hopkins Hospital

1800 Orleans St.
Baltimore, Maryland 21287

410-955-5000