Evaluation of the Phased Radio Frequency Ablation System

NCT01693120 | Terminated Results DMC

• 1 other identifier: VICTORY AF
• Study Type: interventional
• Target: 199
• Locations: 5 countries
• Sites: 40

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.

Conditions

Persistent Atrial Fibrillation

Keywords

ablation; atrial fibrillation; Radio frequency

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Secondary Outcomes (3)

• 6-month Post-procedure Effectiveness

  6 months

• Number of Participants With Acute Procedural Success

  30 minutes

• Number of Participants With Pulmonary Vein Stenosis

  3 months

Study Arms (1)

Ablation

EXPERIMENTAL

Phased RF ablation

Device: Medtronic Phased RF Ablation System

Interventions

Medtronic Phased RF Ablation System DEVICE

Phased RF ablation

Ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (40)

Phoenix Cardiovascular - Banner

Phoenix, Arizona, 85018, United States

Location

Hoag Hospital

Newport Beach, California, 92663, United States

Location

Medical Center of the Rockies

Fort Collins, Colorado, 80528, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

St. Vincent's Ambulatory Care

Jacksonville, Florida, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University

Atlanta, Georgia, 30342, United States

Location

Northeast Georgia Heart Center

Gainesville, Georgia, 30501, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50266, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49525, United States

Location

DLP Marquette Physicians Practice

Marquette, Michigan, 49855, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

HealthEast St Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Asheville Cardiology

Asheville, North Carolina, 28803, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Doylestown Cardiology - VIAA

Doylestown, Pennsylvania, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 17822, United States

Location

Baylor Research Institute - Dallas

Dallas, Texas, 75226, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Baylor Research Institute - Plano

Plano, Texas, 75093, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Swedish Medical Center - Cherry Hill

Seattle, Washington, 98122, United States

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Hopital du Sacre Coeur de Montreal

Montreal, Quebec, Canada

Location

Debreceni Egyetem

Debrecen, Hungary

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Basildon and Thurrock University Hospitals

Basildon, United Kingdom

Location

Blackpool, Fylde and Wyre Hospitals

Blackpool, United Kingdom

Location

Newcastle Upon Tyne Hospitals

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Bob Hokanson, Clinical Research Manager
• Organization: Medtronic AF Solutions

robert.hokanson@medtronic.com

763.526.2811

Study Officials

• John Hummel, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment with Phased RF Ablation System

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 26, 2012
• Study Start: November 1, 2013
• Primary Completion: February 7, 2017
• Study Completion: February 7, 2017
• Last Updated: February 13, 2025
• Results First Posted: March 22, 2018

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); HU (1); NL (2); US (31); GB (3)