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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01693120
First received: September 19, 2012
Last updated: June 29, 2016
Last verified: June 2016
  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: December 2017
Estimated Primary Completion Date: March 2017 (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   (Adult, Senior)
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

  Hide Study Locations
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
St. 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
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
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
Germany
Universitatsklinikum Dusseldorf
Dusseldorf, Germany
Hungary
Debreceni Egyetem
Debrecen, Hungary
Netherlands
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
Investigators
Principal Investigator: John Hummel, MD Ohio State University
  More Information

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: June 29, 2016
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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2016