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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.
ClinicalTrials.gov Identifier: NCT01693120
Recruitment Status : Terminated (The study was stopped solely based on lower than expected enrollment rate.)
First Posted : September 26, 2012
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Persistent Atrial Fibrillation Device: Medtronic Phased RF Ablation System

Study Design

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
Primary Completion Date : February 7, 2017
Study Completion Date : February 7, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Incidence of procedure and/or device related stroke [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Post-procedural effectiveness [ Time Frame: 6 months ]
  2. Acute procedural success [ Time Frame: 30 minutes ]
  3. Pulmonary vein stenosis [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01693120


  Show 41 Study Locations
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
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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