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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01693120
Other study ID # VICTORY AF
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date February 7, 2017

Study information

Verified date September 2018
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 ablation with the Phased RF System.


Recruitment information / eligibility

Status Terminated
Enrollment 199
Est. completion date February 7, 2017
Est. primary completion date February 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Medtronic Phased RF Ablation System
Phased RF ablation

Locations

Country Name City State
Canada Hopital du Sacre Coeur de Montreal Montreal Quebec
Canada McGill University Health Centre Montreal Quebec
Canada Southlake Regional Health Centre Newmarket Ontario
Hungary Debreceni Egyetem Debrecen
Netherlands Catharina Ziekenhuis Eindhoven
Netherlands St. Antonius Ziekenhuis Nieuwegein
United Kingdom Basildon and Thurrock University Hospitals Basildon
United Kingdom Blackpool, Fylde and Wyre Hospitals Blackpool
United Kingdom Newcastle Upon Tyne Hospitals Newcastle Upon Tyne
United States University of Michigan Ann Arbor Michigan
United States Asheville Cardiology Asheville North Carolina
United States Emory University Atlanta Georgia
United States Piedmont Heart Institute Atlanta Georgia
United States University of Virginia Medical Center Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States The Ohio State University Columbus Ohio
United States Baylor Research Institute - Dallas Dallas Texas
United States Iowa Heart Center Des Moines Iowa
United States Doylestown Cardiology - VIAA Doylestown Pennsylvania
United States Inova Fairfax Hospital Falls Church Virginia
United States Medical Center of the Rockies Fort Collins Colorado
United States Northeast Georgia Heart Center Gainesville Georgia
United States Spectrum Health Hospitals Grand Rapids Michigan
United States St. Luke's Episcopal Hospital Houston Texas
United States University of Iowa Iowa City Iowa
United States Mayo Clinic Jacksonville Florida
United States St. Vincent's Ambulatory Care Jacksonville Florida
United States Baptist Health Lexington Lexington Kentucky
United States DLP Marquette Physicians Practice Marquette Michigan
United States Jersey Shore University Medical Center Neptune New Jersey
United States Hoag Hospital Newport Beach California
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Phoenix Cardiovascular - Banner Phoenix Arizona
United States Baylor Research Institute - Plano Plano Texas
United States William Beaumont Hospital Royal Oak Michigan
United States HealthEast St Joseph's Hospital Saint Paul Minnesota
United States Swedish Medical Center - Cherry Hill Seattle Washington
United States Tallahassee Research Institute Tallahassee Florida
United States Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 6 months
Secondary 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) 30 minutes
Secondary 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 3 months
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