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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 3, 2015
Last verified: December 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: 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
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: Yashi Awasthi 763.526.2812 yashasvi.awasthi@medtronic.com

  Hide Study Locations
Locations
United States, Arizona
Banner Good Samaritan Not yet recruiting
Phoenix, Arizona, United States, 85018
United States, California
Hoag Hospital Not yet recruiting
Newport Beach, California, United States, 92663
Contact: Michaela Toney    949-764-4510    michaela.toney@hoag.org   
Contact: Amanda Ruelas    (949) 764-4509    amanda.ruelas@hoag.org   
Principal Investigator: Rajesh Banker         
United States, Colorado
Medical Center of the Rockies Not yet recruiting
Fort Collins, Colorado, United States, 80528
Contact: Dori Burnette    970-624-5296    Dori.burnette@uchealth.org   
Principal Investigator: Russell Heath         
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Judy Olmos    904-953-7898    Olmos.Judy@mayo.edu   
Principal Investigator: Kalpathi Venkatachalam         
St. Vincent's Ambulatory Care Active, not recruiting
Jacksonville, Florida, United States
Tallahassee Research Institute Not yet recruiting
Tallahassee, Florida, United States, 32308
Contact: Patty Knap    850-431-5024    patty.knap@tmh.org   
Principal Investigator: Farhat Khairallah         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Julia Daugherty    404-605-2301    Julia.Daugherty@piedmont.org   
Principal Investigator: Andrew Wickliffe         
Emory University Recruiting
Atlanta, Georgia, United States, 30342
Contact: Cindy Barnes    678-843-6093    cynthia.barnes@emory.edu   
Principal Investigator: David DeLurgio         
Northeast Georgia Heart Center Not yet recruiting
Gainesville, Georgia, United States, 30501
Contact: Donna Patrick    678-989-5001    DPatrick@pulseoftomorrow.org   
Principal Investigator: Salem Sayar         
WellStar Medical Withdrawn
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Laura Pollan    312-926-7312    lpollan@nm.org   
Principal Investigator: Bradley Knight         
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50266
Contact: Cecily Decklever    515-633-3843    cdecklever@iowaheart.com   
Principal Investigator: Robert Hoyt         
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Joni Hartman    319-384-1627    joni-hartman@uiowa.edu   
Principal Investigator: Michael Giudici         
United States, Kentucky
Lexington Cardiology Consultants Not yet recruiting
Lexington, Kentucky, United States, 40503
Contact: Lori Angel    859-260-4484    Langel@BHSI.com   
Principal Investigator: Gery Tomassoni         
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
Contact: Sangeeta Lathkar-Pradhan    734-232-5022    slathkar@med.umich.edu   
Principal Investigator: Aman Chugh         
Spectrum Health Hospitals Recruiting
Grand Rapids, Michigan, United States, 49525
Contact: Ryan Sagorski    616-486-2298    ryan.sagorski@spectrumhealth.org   
Principal Investigator: Darryl Elmouchi         
DLP Marquette Physicians Practice Not yet recruiting
Marquette, Michigan, United States, 49855
Contact: Lori Piggott    906-225-7190    lori.piggott@mghs.org   
Principal Investigator: Rudolph Evonich         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Patti Naismith    248-898-8141    pnaismith@beaumont.edu   
Principal Investigator: David Haines         
United States, Minnesota
HealthEast St Joseph's Hospital Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Joyce Riestenberg-Smith    651-471-2671    Jmriestenberg@healtheast.org   
Principal Investigator: Stuart Adler         
United States, New Jersey
Jersey Shore University Medical Center Not yet recruiting
Neptune, New Jersey, United States, 07753
Contact: Linda Murphy    732-776-4796    LMurphy@meridianhealth.com   
Principal Investigator: Ashish Patel         
United States, North Carolina
Asheville Cardiology Recruiting
Asheville, North Carolina, United States, 28803
Contact: Olivia Lim    828-274-6000 ext 112    Olivia.Lim@msj.org   
Principal Investigator: Joseph Souza         
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kathy Sankovic    216-445-6916    SANKOVK@ccf.org   
Principal Investigator: Oussama Wazni         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer Bremer    614-685-4622    jennifer.bremer@osumc.edu   
Principal Investigator: Steven Kalbfleisch         
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
Contact: Mary Gnap    215-349-8446    Mary.gnap@uphs.upenn.edu   
Principal Investigator: Gregory Supple         
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
Contact: Cathy Headley    214-820-7108    cathyhe@baylorhealth.edu   
Principal Investigator: Robert Kowal         
St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Stephen Harold    832-355-3494    sharold@stlukeshealth.org   
Principal Investigator: Abdi Rasekh         
Baylor Research Institute - Plano Recruiting
Plano, Texas, United States, 75093
Contact: Brigette Obokhae    469-814-4185    Brigette.Obokhae@baylorhealth.edu   
Principal Investigator: Brian DeVille         
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Mary Jane Strickland    434-982-6401    mjs7w@virginia.edu   
Principal Investigator: Michael Mangrum         
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Christina Kim    703-776-8008    Narae.kim@inova.org   
Principal Investigator: Adam Strickberger         
United States, Washington
Swedish Medical Center - Cherry Hill Recruiting
Seattle, Washington, United States, 98122
Contact: Christine Goetz    206-215-2843    Christine.Goetz@swedish.org   
Principal Investigator: Darryl Wells         
Canada, Ontario
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Contact: Sherri Patterson    (905) 952-2812    spatterson@southlakeregional.org   
Principal Investigator: Atul Verma         
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Lilia Wang    (514) 934-1934 ext 45890    lilia.wang@muhc.mcgill.ca   
Principal Investigator: Vidal Essebag         
Hopital du Sacre Coeur de Montreal Recruiting
Montreal, Quebec, Canada
Contact: Ann Langlois    (514) 338-2222 ext 3722    Langlois@crhsc.rtss.qc.ca   
Principal Investigator: Marcio Sturmer         
Germany
Universitatsklinikum Dusseldorf Active, not recruiting
Dusseldorf, Germany
Hungary
Debreceni Egyetem Recruiting
Debrecen, Hungary
Contact       valeria@med.unideb.hu   
Principal Investigator: Zoltan Csanadi         
Netherlands
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands
Contact: Cassandra Hoorn       cassandra.hoorn@catharinaziekenhuis.nl   
Principal Investigator: Timothy Simmers         
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Contact: Inke Albersen       i.albersen@antoniusziekenhuis.nl   
Principal Investigator: Lucas Boersma         
United Kingdom
Basildon and Thurrock University Hospitals Not yet recruiting
Basildon, United Kingdom
Blackpool, Fylde and Wyre Hospitals Recruiting
Blackpool, United Kingdom
Contact: Stephen Preston       stephen.preston@bfwhospitals.nhs.uk   
Principal Investigator: Scott Gall         
Newcastle Upon Tyne Hospitals Recruiting
Newcastle Upon Tyne, United Kingdom
Contact: Alla Narytnyk       alla.narytnyk@nuth.nhs.uk   
Principal Investigator: Stephen Murray         
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: December 3, 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 May 25, 2016