Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- Procedure: Standard PVI AblationProcedure: FIRM-Guided Procedure and PVI
- Registration Number
- NCT02274857
- Lead Sponsor
- Abbott Medical Devices
- 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 the treatment of persistent atrial fibrillation (AF).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard PVI Ablation Standard PVI Ablation Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF. FIRM-guided Procedure and PVI FIRM-Guided Procedure and PVI FIRM-guided procedure followed by standard catheter ablation including PVI.
- Primary Outcome Measures
Name Time Method Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure Within 7-10 days of the Procedure Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure. 3-month follow up Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure. 3-12 months post study treatment Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure 3 to 12 months post study treatment
- Secondary Outcome Measures
Name Time Method Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts Immediately post procedure
Trial Locations
- Locations (18)
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Weill Medical College at Cornell University
🇺🇸New York, New York, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Hackensack UMC
🇺🇸Hackensack, New Jersey, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Herz- und Diabeteszentrum Bad Oeynhausen
🇩🇪Bad Oeynhausen, Minden-Lübbecke, Germany
Klinikum Coburg GmbH
🇩🇪Coburg, Germany
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
🇩🇪Dresden, Germany
Kardiologische Gemeinschaftspraxis am Park Sanssouci
🇩🇪Potsdam, Germany
Leipzig Heart Institute GmbH
🇩🇪Leipzig, Germany
Städtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Arizona Heart Rhythm Center
🇺🇸Phoenix, Arizona, United States
St. Vincent Hospital
🇺🇸Indianapolis, Indiana, United States
Indiana University - Krannert Institute of Cardiology
🇺🇸Indianapolis, Indiana, United States
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany