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.
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
sites
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Indianapolis, Indiana 46202
Principal Investigator: John M Miller, MD
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Phoenix, Arizona 85016
Principal Investigator: Dr. Vijendra Swarup, MD
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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