Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
Completed · Not applicable
Conditions studied: Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT02799043
- Run by
- Abbott Medical Devices
- People needed
- 269
- Starts
- 2016-06-01
- Expected to finish
- 2020-07-01
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Arizona Heart Rhythm Research Cente — Phoenix, Arizona, United States
- Ventura Cardiology Consultants — Ventura, California, United States
- Broward Health — Fort Lauderdale, Florida, United States
- St. Vincent's HealthCare — Jacksonville, Florida, United States
- Loyola University — Chicago, Illinois, United States
- Northwestern University - Bluhm Cardiovascular Institute — Chicago, Illinois, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- Englewood Hospital and Medical Center — Englewood, New Jersey, United States
- Ohio State University — Columbus, Ohio, United States
- University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Virginia Heart — Falls Church, Virginia, United States
- University Hospital of Antwerp — Antwerp, Flanders, Belgium
- Klinikum Coburg — Coburg, Bavaria, Germany
- Furth Medical Clinic for Heart and Lung Diseases — Fürth, Bavaria, Germany
- The Dr. Müller Kliniken — Munich, Bavaria, Germany
- Kardiologische Gemeinschaftspraxis am Park Sanssouci — Potsdam, Brandenburg, Germany
- Kardiocentrum Frankfurt — Frankfurt, Main, Germany
- Leipzig Heart Institute GmbH — Leipzig, Saxony, Germany
- Luebeck University Heart Center — Lübeck, Schleswig-Holstein, Germany
- Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia — Bad Oeynhausen, Germany
- UKB (Unfallkrankenhaus Berlin) — Berlin, Germany
- Praxisklinik Herz und Gefäße Dresden — Dresden, Germany
- Medical Center Rotterdam (Erasmus MC) — Rotterdam, South Holland, Netherlands
Full record on ClinicalTrials.gov
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