Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:2/1/2019
Start Date:October 2014
End Date:November 10, 2018

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Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)

The study is a prospective, multicenter, randomized study to assess the safety and
effectiveness of FIRM procedures followed by conventional ablation including PVI versus a
standard PVI procedure for the treatment of persistent atrial fibrillation.


Key Inclusion Criteria:

- At least two (2) documented episodes of persistent atrial fibrillation during prior 3
months

- Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic
medications

- Left atrial diameter < 6.0 cm

Key Exclusion Criteria:

- Previous AF Ablation

- Presence of structural heart disease

- NYHA Class IV.

- Ejection fraction < 35%.

- History of myocardial infarction (MI) within the past three months.
We found this trial at
11
sites
Indianapolis, Indiana
Principal Investigator: Jeffrey Olson
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Bad Oeynhausen, Minden-Lübbecke 32545
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: John Hummel, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Hackensack, New Jersey 07601
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Hackensack, NJ
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Indianapolis, Indiana 46202
Principal Investigator: Gopi Dandamudi, MD
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Indianapolis, IN
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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445 E 69th St
New York, New York 10021
(212) 746-1067
Principal Investigator: Bruce Lerman, M.D.
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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New York, NY
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Newport Beach, California 92658
Principal Investigator: Rajesh Banker, MD
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Newport Beach, CA
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Phoenix, Arizona 53226
Principal Investigator: Vijay Swarup, MD
Phone: 480-659-7583
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Phoenix, AZ
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Wilkes-Barre, Pennsylvania 18711
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Wilkes-Barre, PA
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