Evaluation of the Phased Radio Frequency Ablation System (VICTORY-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693120
Recruitment Status : Terminated (The study was stopped solely based on lower than expected enrollment rate.)
First Posted : September 26, 2012
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation 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.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Device: Medtronic Phased RF Ablation System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Treatment with Phased RF Ablation System
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation
Study Start Date : November 2013
Actual Primary Completion Date : February 7, 2017
Actual Study Completion Date : February 7, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ablation
Phased RF ablation
Device: Medtronic Phased RF Ablation System
Phased RF ablation

Primary Outcome Measures :
  1. Number of Participants With Procedure and/or Device Related Stroke [ Time Frame: 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 :
  1. 6-month Post-procedure Effectiveness [ Time Frame: 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

  2. Number of Participants With Acute Procedural Success [ Time Frame: 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)

  3. Number of Participants With Pulmonary Vein Stenosis [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • History of symptomatic persistent or long-standing persistent atrial fibrillation
  • Failure of at least one anti-arrhythmic drug

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01693120

  Hide Study Locations
United States, Arizona
Phoenix Cardiovascular - Banner
Phoenix, Arizona, United States, 85018
United States, California
Hoag Hospital
Newport Beach, California, United States, 92663
United States, Colorado
Medical Center of the Rockies
Fort Collins, Colorado, United States, 80528
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
St. Vincent's Ambulatory Care
Jacksonville, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Emory University
Atlanta, Georgia, United States, 30342
Northeast Georgia Heart Center
Gainesville, Georgia, United States, 30501
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50266
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States, 49525
DLP Marquette Physicians Practice
Marquette, Michigan, United States, 49855
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
HealthEast St Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
United States, New Jersey
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07753
United States, North Carolina
Asheville Cardiology
Asheville, North Carolina, United States, 28803
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Doylestown Cardiology - VIAA
Doylestown, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 17822
United States, Texas
Baylor Research Institute - Dallas
Dallas, Texas, United States, 75226
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Baylor Research Institute - Plano
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
United States, Washington
Swedish Medical Center - Cherry Hill
Seattle, Washington, United States, 98122
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Hopital du Sacre Coeur de Montreal
Montreal, Quebec, Canada
Debreceni Egyetem
Debrecen, Hungary
Catharina Ziekenhuis
Eindhoven, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
United Kingdom
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
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Principal Investigator: John Hummel, MD Ohio State University
  Study Documents (Full-Text)

Documents provided by Medtronic Atrial Fibrillation Solutions:
Study Protocol  [PDF] November 21, 2014
Statistical Analysis Plan  [PDF] July 18, 2013

Responsible Party: Medtronic Atrial Fibrillation Solutions Identifier: NCT01693120     History of Changes
Other Study ID Numbers: VICTORY AF
First Posted: September 26, 2012    Key Record Dates
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medtronic Atrial Fibrillation Solutions:
atrial fibrillation
Radio frequency

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes