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

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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
19
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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10 Wilrijkstraat
Antwerp, Flanders 2650
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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Bellevue, Washington 98004
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1032 West Sheridan Road
Chicago, Illinois 60153
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Falls Church, Virginia 22042
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1600 Southeast 3rd Avenue
Fort Lauderdale, Florida 33311
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Indianapolis, Indiana 46202
Principal Investigator: John M Miller, MD
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Jacksonville, Florida 32204
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Lexington, Kentucky 40503
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New York, New York 10029
Principal Investigator: Subbarao Choudry, MD
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Newport Beach, California 92658
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85016
Principal Investigator: Dr. Vijendra Swarup, MD
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Ventura, California 93003
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