Persistent Atrial FibrillationVICTORY-AFNCT01693120

Evaluation of the Phased Radio Frequency Ablation System

A study testing Medtronic Phased RF Ablation System in people with Persistent Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 40 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Persistent Atrial Fibrillation
What is being tested?: Medtronic Phased RF Ablation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 40 sitesin 5 countries
Study dates: Nov 2013to 7 Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of symptomatic persistent or long-standing persistent atrial fibrillation
Failure of at least one anti-arrhythmic drug

Who cannot join

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

Trial locations and contacts

40 sites in 5 countries.

Country

City, postcode or hospital

40 sites in 5 countries

United States31 sites

University of Michigan
Ann Arbor, Michigan
Asheville Cardiology
Asheville, North Carolina, 28803
Piedmont Heart Institute
Atlanta, Georgia, 30309
Emory University
Atlanta, Georgia, 30342
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Baylor Research Institute - Dallas
Dallas, Texas, 75226
Iowa Heart Center
Des Moines, Iowa, 50266
Doylestown Cardiology - VIAA
Doylestown, Pennsylvania
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Medical Center of the Rockies
Fort Collins, Colorado, 80528
Northeast Georgia Heart Center
Gainesville, Georgia, 30501
Spectrum Health Hospitals
Grand Rapids, Michigan, 49525
St. Luke's Episcopal Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic
Jacksonville, Florida, 32224
St. Vincent's Ambulatory Care
Jacksonville, Florida
Baptist Health Lexington
Lexington, Kentucky, 40503
DLP Marquette Physicians Practice
Marquette, Michigan, 49855
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Hoag Hospital
Newport Beach, California, 92663
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Phoenix Cardiovascular - Banner
Phoenix, Arizona, 85018
Baylor Research Institute - Plano
Plano, Texas, 75093
William Beaumont Hospital
Royal Oak, Michigan, 48073
HealthEast St Joseph's Hospital
Saint Paul, Minnesota, 55102
Swedish Medical Center - Cherry Hill
Seattle, Washington, 98122
Tallahassee Research Institute
Tallahassee, Florida, 32308
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 17822

Other trials in United States

Canada3 sites

McGill University Health Centre
Montreal, Quebec, H3G 1A4
Hopital du Sacre Coeur de Montreal
Montreal, Quebec
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9

Other trials in Canada

United Kingdom3 sites

Basildon and Thurrock University Hospitals
Basildon
Blackpool, Fylde and Wyre Hospitals
Blackpool
Newcastle Upon Tyne Hospitals
Newcastle upon Tyne

Other trials in United Kingdom

Netherlands2 sites

Catharina Ziekenhuis
Eindhoven
St. Antonius Ziekenhuis
Nieuwegein

Other trials in Netherlands

Hungary1 site

Debreceni Egyetem
Debrecen

Other trials in Hungary

About this study

Official title: Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation

Conditions: Persistent Atrial Fibrillation
Being tested: Medtronic Phased RF Ablation System
Keywords: ablation, atrial fibrillation, Radio frequency
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medtronic Phased RF Ablation SystemDevice
Phased RF ablation

Study groups in NCT01693120
Study group	Role	What they receive
Ablation	Experimental	Phased RF ablation Receives: Device: Medtronic Phased RF Ablation System

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Procedure and/or Device Related Stroke
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
Measured: 30 days

Secondary outcomes (3)

6-month Post-procedure Effectiveness
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
Measured: 6 months
Number of Participants With Acute Procedural Success
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)
Measured: 30 minutes
Number of Participants With Pulmonary Vein Stenosis
Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 20137 Feb 2017

First posted26 Sep 2012 (estimated)
Study startNov 2013
Primary completion7 Feb 2017
Study completion7 Feb 2017

Why it stopped: The study was stopped solely based on lower than expected enrollment rate.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Ablation SolutionsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Treatment with Phased RF Ablation System
Masking: None (open label)
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01693120
Sponsor's protocol ID: VICTORY AF
Acronym: VICTORY-AF
Status last verified: Feb 2025
First submitted: 19 Sep 2012
Last updated: 13 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation
Atrial Fibrillation
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation

All Persistent Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation
ClinicalTrials.gov ID: NCT01693120
Acronym / sponsor ID: VICTORY-AF / VICTORY AF
Conditions: Persistent Atrial Fibrillation
Keywords: ablation, atrial fibrillation, Radio frequency
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was stopped solely based on lower than expected enrollment rate.
Enrolment: 199 participants (actual)
Lead sponsor: Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: 7 Feb 2017 (actual)
Study completion: 7 Feb 2017 (actual)
First posted: 26 Sep 2012 (estimated)
Results: Posted 22 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Treatment with Phased RF Ablation System

Arm	Type	Receives
Ablation	Experimental	Device: Medtronic Phased RF Ablation SystemPhased RF ablation

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

History of symptomatic persistent or long-standing persistent atrial fibrillation
Failure of at least one anti-arrhythmic drug

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medtronic Phased RF Ablation SystemPhased RF ablation	Device	Ablation

Primary outcome

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

3 secondary outcomes

6-month Post-procedure Effectiveness
Time frame: 6 months
Number of Participants With Acute Procedural Success
Time frame: 30 minutes
Number of Participants With Pulmonary Vein Stenosis
Time frame: 3 months

Results and safety

Results posted to the registry on 22 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ablation	199	129

Primary outcome: Number of Participants With Procedure and/or Device Related Stroke

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Ablation n = 127
Value	2

Ablation: rate: 1.6, p = 0.175, exact binomial test

Population analysed: All subjects with a Phased RF ablation procedure who did not have a non-investigational catheter placed in the left atrium

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ablation	28 of 129 (21.7%)	38 of 129 (29.5%)	0 of 129

Limitations and caveats (from the sponsor): The study stopped enrolling prematurely due to slow enrollment. Since the achieved sample size is 57% smaller than the planned sample size of 300 evaluable subjects, the study objectives could not be properly evaluated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Persistent Atrial Fibrillation

Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation
Atrial Fibrillation
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Hummel, MD principal investigator

Ohio State University

40 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Phased RF Ablation System in people with Persistent Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 40 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Canada, United Kingdom, Netherlands, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Procedure and/or Device Related Stroke (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01693120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.