Status:
COMPLETED
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures
Lead Sponsor:
Abbott Medical Devices
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- Previous AF Ablation
- Presence of structural heart disease
- New York Heart Association (NYHA) Class IV.
- Ejection fraction \< 35%.
- History of myocardial infarction (MI) within the past three months.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2018
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT02274857
Start Date
October 1 2014
End Date
November 10 2018
Last Update
February 7 2020
Active Locations (18)
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1
Arizona Heart Rhythm Center
Phoenix, Arizona, United States, 85013
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
3
Loyola University Medical Center
Maywood, Illinois, United States, 60153
4
Indiana University - Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202