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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
199

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ablation
Phased RF ablation
Device: Medtronic Phased RF Ablation System
Phased RF ablation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Ablation Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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