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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Medtronic Atrial Fibrillation Solutions
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01693120
First received: September 19, 2012
Last updated: May 13, 2015
Last verified: May 2015
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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

  Hide Study Locations
Locations
United States, Arizona
Banner Good Samaritan Not yet recruiting
Phoenix, Arizona, United States, 85018
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
St. Vincent's Ambulatory Care Active, not recruiting
Jacksonville, Florida, United States
Tallahassee Research Institute Not yet recruiting
Tallahassee, Florida, United States, 32308
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Emory University Recruiting
Atlanta, Georgia, United States, 30342
WellStar Medical Not yet recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50266
University of Iowa Recruiting
Iowa City, Iowa, United States
United States, Kentucky
Lexington Cardiology Consultants Not yet recruiting
Lexington, Kentucky, United States, 40503
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, 49525
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States
United States, Minnesota
HealthEast St Joseph's Hospital Recruiting
St. Paul, Minnesota, United States, 55102
United States, North Carolina
Asheville Cardiology Recruiting
Asheville, North Carolina, United States, 28803
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, 27710
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Doylestown Cardiology - VIAA Active, not recruiting
Doylestown, Pennsylvania, United States
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Geisinger Wyoming Valley Medical Center Not yet recruiting
Wilkes-Barre, Pennsylvania, United States, 17822
United States, South Carolina
Columbia Heart Clinic Withdrawn
Columbia, South Carolina, United States
United States, Texas
Baylor Research Institute - Dallas Recruiting
Dallas, Texas, United States, 75226
St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
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, 22042
United States, Washington
Swedish Medical Center - Cherry Hill Recruiting
Seattle, Washington, United States, 98122
Canada, Ontario
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Canada, Quebec
Hopital du Sacre Coeur de Montreal Not yet recruiting
Montreal, Quebec, Canada
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3G 1A4
Germany
Universitatsklinikum Dusseldorf Recruiting
Dusseldorf, Germany
Hungary
Debreceni Egyetem Recruiting
Debrecen, Hungary
Netherlands
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 Recruiting
Blackpool, United Kingdom
Newcastle Upon Tyne Hospitals Recruiting
Newcastle Upon Tyne, United Kingdom
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Investigators
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: May 13, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 01, 2015