Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)
Status: Completed
Location: See all (24) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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).
Locations
United States
Arizona
Arizona Heart Rhythm Research Cente
Phoenix
California
Ventura Cardiology Consultants
Ventura
Florida
Broward Health
Fort Lauderdale
St. Vincent's HealthCare
Jacksonville
Illinois
Loyola University
Chicago
Northwestern University - Bluhm Cardiovascular Institute
Chicago
Maryland
Johns Hopkins Hospital
Baltimore
New Jersey
Englewood Hospital and Medical Center
Englewood
Ohio
Ohio State University
Columbus
Pennsylvania
University of Pennsylvania Health System
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
Virginia
Virginia Heart
Falls Church
Other Locations
Belgium
University Hospital of Antwerp
Antwerp
Germany
Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen
UKB (Unfallkrankenhaus Berlin)
Berlin
Klinikum Coburg
Coburg
Praxisklinik Herz und Gefäße Dresden
Dresden
Kardiocentrum Frankfurt
Frankfurt
Furth Medical Clinic for Heart and Lung Diseases
Fürth
Leipzig Heart Institute GmbH
Leipzig
Luebeck University Heart Center
Lübeck
The Dr. Müller Kliniken
Munich
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam
Netherlands
Medical Center Rotterdam (Erasmus MC)
Rotterdam
Time Frame
Start Date: 2016-06
Completion Date: 2020-07
Participants
Target number of participants: 269
Treatments
Active_comparator: Standard PVI
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Experimental: FIRM-guided Procedure and PVI
FIRM-guided procedure followed by PVI.
Authors
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices