Evaluation of the Phased Radio Frequency Ablation System
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- Device: Medtronic Phased RF Ablation System
- Registration Number
- NCT01693120
- Lead Sponsor
- Medtronic Cardiac Ablation Solutions
- Brief Summary
VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in subjects with persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 199
- History of symptomatic persistent or long-standing persistent atrial fibrillation
- Failure of at least one anti-arrhythmic drug
- Structural heart disease
- Prior ablation in left atrium for AF
- Known sensitivities (or allergy) to heparin, warfarin, contrast media
- Contraindicated for MRI
- Invasive cardiovascular procedure performed or planned within 3 month period of ablation procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ablation Medtronic Phased RF Ablation System Phased RF ablation
- Primary Outcome Measures
Name Time Method Number of Participants With Procedure and/or Device Related Stroke 30 days A stroke with with a symptom onset date within 30 days of an ablation procedure where at least one Phased RF ablation catheter was deployed into the left atrium considered related to the procedure and/or the investigational device by the independent clinical events committee
- Secondary Outcome Measures
Name Time Method 6-month Post-procedure Effectiveness 6 months For a participant, the 6-month effectiveness defined as meeting all of the following criteria: (1) acute procedural success, (2) greater than 90% reduction in atrial fibrillation/atrial flutter episodes lasting longer than 10 minutes as measured by 48-hour ambulatory ECG, (3) No amiodarone use for 90 days and no class I or class III antiarrhythmic drugs for at least 60 days prior to 6-month ambulatory ECG, and (4) free from direct current cardioversion for at least 60 days prior to the 6-month ambulatory ECG
Number of Participants With Acute Procedural Success 30 minutes Acute procedural success defined as: (1) Only Phased RF ablation catheters used in the left atrium, (2) all targeted pulmonary veins isolated, (3) all complex fractionated atrial electrograms and high frequency intracardiac electrogram amplitudes were mapped and ablated, and (4) sinus rhythm was restored at the end of the ablation procedure (with or without cardioversion)
Number of Participants With Pulmonary Vein Stenosis 3 months Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure
Trial Locations
- Locations (40)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Hoag Hospital
🇺🇸Newport Beach, California, United States
Medical Center of the Rockies
🇺🇸Fort Collins, Colorado, United States
St. Vincent's Ambulatory Care
🇺🇸Jacksonville, Florida, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northeast Georgia Heart Center
🇺🇸Gainesville, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
DLP Marquette Physicians Practice
🇺🇸Marquette, Michigan, United States
Spectrum Health Hospitals
🇺🇸Grand Rapids, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
HealthEast St Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Asheville Cardiology
🇺🇸Asheville, North Carolina, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Doylestown Cardiology - VIAA
🇺🇸Doylestown, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Baylor Research Institute - Dallas
🇺🇸Dallas, Texas, United States
Baylor Research Institute - Plano
🇺🇸Plano, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Swedish Medical Center - Cherry Hill
🇺🇸Seattle, Washington, United States
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Hopital du Sacre Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Debreceni Egyetem
ðŸ‡ðŸ‡ºDebrecen, Hungary
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Basildon and Thurrock University Hospitals
🇬🇧Basildon, United Kingdom
Blackpool, Fylde and Wyre Hospitals
🇬🇧Blackpool, United Kingdom
Newcastle Upon Tyne Hospitals
🇬🇧Newcastle Upon Tyne, United Kingdom
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Phoenix Cardiovascular - Banner
🇺🇸Phoenix, Arizona, United States