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 |
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.
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 46202
Principal Investigator: Gopi Dandamudi, MD
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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281 W. Lane Ave
Columbus, Ohio 43210
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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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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445 E 69th St
New York, New York 10021
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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Newport Beach, California 92658
Principal Investigator: Rajesh Banker, MD
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Phoenix, Arizona 53226
Principal Investigator: Vijay Swarup, MD
Phone: 480-659-7583
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