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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Medtronic Atrial Fibrillation Solutions
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
First received: September 19, 2012
Last updated: February 2, 2015
Last verified: February 2015

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 Intervention Phase
Persistent Atrial Fibrillation
Device: Medtronic Phased RF Ablation System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:
  • Incidence of procedure and/or device related stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post-procedural effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Acute procedural success [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Pulmonary vein stenosis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Single procedure effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Atrial fibrillation burden reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Asymptomatic cerebral embolism [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Peri-procedural serious adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Peri-procedural stroke and transient ischemic attack [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Summarize adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: November 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ablation
Phased RF ablation
Device: Medtronic Phased RF Ablation System
Phased RF ablation


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693120

Contact: Jen Lahr 763.526.2781 Jen.Lahr@medtronic.com
Contact: Jay Kelley 760.827.0076 jay.l.kelley@medtronic.com

  Hide Study Locations
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States
St. Vincent's Ambulatory Care Recruiting
Jacksonville, Florida, United States
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States
University of Iowa Not yet recruiting
Iowa City, Iowa, United States
United States, Massachusetts
Brigham and Women's Hospital Withdrawn
Boston, Massachusetts, United States
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States
Spectrum Health Hospitals Recruiting
Grand Rapids, Michigan, United States
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States
United States, Minnesota
HealthEast St Joseph's Hospital Recruiting
St. Paul, Minnesota, United States
United States, North Carolina
Asheville Cardiology Recruiting
Asheville, North Carolina, United States
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States
Duke University Medical Center Recruiting
Durham, North Carolina, United States
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States
The Ohio State University Recruiting
Columbus, Ohio, United States
United States, Pennsylvania
Doylestown Cardiology - VIAA Recruiting
Doylestown, Pennsylvania, United States
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States
United States, South Carolina
Columbia Heart Clinic Not yet recruiting
Columbia, South Carolina, United States
United States, Texas
Baylor Research Institute - Dallas Recruiting
Dallas, Texas, United States
St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States
Baylor Research Institute - Plano Recruiting
Plano, Texas, United States
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottesville, Virginia, United States
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States
United States, Washington
Swedish Medical Center - Cherry Hill Recruiting
Seattle, Washington, United States
Canada, Ontario
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada
Canada, Quebec
Hopital du Sacre Coeur de Montreal Not yet recruiting
Montreal, Quebec, Canada
McGill University Health Centre Recruiting
Montreal, Quebec, Canada
Universitatsklinikum Dusseldorf Recruiting
Dusseldorf, Germany
Debreceni Egyetem Recruiting
Debrecen, Hungary
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
United Kingdom
Basildon and Thurrock University Hospitals Not yet recruiting
Basildon, United Kingdom
Blackpool, Fylde and Wyre Hospitals Not yet recruiting
Blackpool, United Kingdom
Newcastle Upon Tyne Hospitals Not yet recruiting
Newcastle Upon Tyne, United Kingdom
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Principal Investigator: John Hummel, MD Ohio State University
  More Information

No publications provided

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01693120     History of Changes
Other Study ID Numbers: VICTORY AF
Study First Received: September 19, 2012
Last Updated: February 2, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 23, 2015