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

February 11, 2025 updated by: Medtronic Cardiac Ablation Solutions

Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre
      • Montreal, Quebec, Canada
        • Hopital Du Sacre Coeur de Montreal
  • Hungary
      • Debrecen, Hungary
        • Debreceni Egyetem
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
  • United Kingdom
      • Basildon, United Kingdom
        • Basildon and Thurrock University Hospitals
      • Blackpool, United Kingdom
        • Blackpool, Fylde and Wyre Hospitals
      • Newcastle Upon Tyne, United Kingdom
        • Newcastle Upon Tyne Hospitals
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Phoenix Cardiovascular - Banner
    • California
      • Newport Beach, California, United States, 92663
        • Hoag Hospital
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Medical Center of the Rockies
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Jacksonville, Florida, United States
        • St. Vincent's Ambulatory Care
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
      • Atlanta, Georgia, United States, 30342
        • Emory University
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Heart Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Spectrum Health Hospitals
      • Marquette, Michigan, United States, 49855
        • DLP Marquette Physicians Practice
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • HealthEast St Joseph's Hospital
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Cardiology
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
        • Doylestown Cardiology - VIAA
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Wilkes-Barre, Pennsylvania, United States, 17822
        • Geisinger Wyoming Valley Medical Center
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Research Institute - Dallas
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital
      • Plano, Texas, United States, 75093
        • Baylor Research Institute - Plano
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center - Cherry Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ablation
Phased RF ablation
Device: Medtronic Phased RF Ablation System
Phased RF ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Procedure and/or Device Related Stroke
Time Frame: 30 days
A stroke with with a symptom onset date within 30 days of an ablation procedure where at least one Phased RF ablation catheter was deployed into the left atrium considered related to the procedure and/or the investigational device by the independent clinical events committee
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month Post-procedure Effectiveness
Time Frame: 6 months
For a participant, the 6-month effectiveness defined as meeting all of the following criteria: (1) acute procedural success, (2) greater than 90% reduction in atrial fibrillation/atrial flutter episodes lasting longer than 10 minutes as measured by 48-hour ambulatory ECG, (3) No amiodarone use for 90 days and no class I or class III antiarrhythmic drugs for at least 60 days prior to 6-month ambulatory ECG, and (4) free from direct current cardioversion for at least 60 days prior to the 6-month ambulatory ECG
6 months
Number of Participants With Acute Procedural Success
Time Frame: 30 minutes
Acute procedural success defined as: (1) Only Phased RF ablation catheters used in the left atrium, (2) all targeted pulmonary veins isolated, (3) all complex fractionated atrial electrograms and high frequency intracardiac electrogram amplitudes were mapped and ablated, and (4) sinus rhythm was restored at the end of the ablation procedure (with or without cardioversion)
30 minutes
Number of Participants With Pulmonary Vein Stenosis
Time Frame: 3 months
Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Ablation Solutions

Investigators

  • Principal Investigator: John Hummel, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

February 7, 2017

Study Completion (Actual)

February 7, 2017

Study Registration Dates

First Submitted

September 19, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimated)

September 26, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICTORY AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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