Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
- Conditions
- Persistent Atrial FibrillationParoxysmal Atrial Fibrillation
- Interventions
- Procedure: Standard PVIProcedure: FIRM-Guided Procedure and PVI
- Registration Number
- NCT02799043
- Lead Sponsor
- Abbott Medical Devices
- Brief 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.
- Detailed Description
The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat AF ablation procedures.
This study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard PVI Standard PVI Standard catheter ablation including pulmonary vein isolation (PVI) procedure. FIRM-guided Procedure and PVI FIRM-Guided Procedure and PVI FIRM-guided procedure followed by PVI.
- Primary Outcome Measures
Name Time Method Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure. 12 months post procedure Single procedure freedom from recurrence from 3-12 months post procedure
Freedom From Serious Adverse Events Related to the Procedure 12-month post procedure Freedom from any procedure-related serious adverse event from 0-12 months post procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Praxisklinik Herz und Gefäße Dresden
🇩🇪Dresden, Germany
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States
Arizona Heart Rhythm Research Cente
🇺🇸Phoenix, Arizona, United States
Kardiocentrum Frankfurt
🇩🇪Frankfurt, Main, Germany
The Dr. Müller Kliniken
🇩🇪Munich, Bavaria, Germany
Kardiologische Gemeinschaftspraxis am Park Sanssouci
🇩🇪Potsdam, Brandenburg, Germany
UKB (Unfallkrankenhaus Berlin)
🇩🇪Berlin, Germany
Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia
🇩🇪Bad Oeynhausen, Germany
Northwestern University - Bluhm Cardiovascular Institute
🇺🇸Chicago, Illinois, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Ventura Cardiology Consultants
🇺🇸Ventura, California, United States
Broward Health
🇺🇸Fort Lauderdale, Florida, United States
Loyola University
🇺🇸Chicago, Illinois, United States
University Hospital of Antwerp
🇧🇪Antwerp, Flanders, Belgium
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Leipzig Heart Institute GmbH
🇩🇪Leipzig, Saxony, Germany
Furth Medical Clinic for Heart and Lung Diseases
🇩🇪Fürth, Bavaria, Germany
St. Vincent's HealthCare
🇺🇸Jacksonville, Florida, United States
Klinikum Coburg
🇩🇪Coburg, Bavaria, Germany
Luebeck University Heart Center
🇩🇪Lübeck, Schleswig-Holstein, Germany
Medical Center Rotterdam (Erasmus MC)
🇳🇱Rotterdam, South Holland, Netherlands
Virginia Heart
🇺🇸Falls Church, Virginia, United States