Evaluation of the Phased Radio Frequency Ablation System

Persistent Atrial Fibrillation Clinical Trial

— VICTORY-AF  

Official title:

Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01693120
• Other study ID #: VICTORY AF
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

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