Clinical trial NCT01693120: Evaluation of the Phased Radio Frequency Ablation System
Official title: Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: ablation
atrial fibrillation
Radio frequency
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2012-09-26
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Treatment with Phased RF Ablation System
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Procedure and/or Device Related Stroke
timeFrame: 30 days
Secondary outcomes:
measure: 6-month Post-procedure Effectiveness
timeFrame: 6 months
measure: Number of Participants With Acute Procedural Success
timeFrame: 30 minutes
measure: Number of Participants With Pulmonary Vein Stenosis
timeFrame: 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Cardiovascular - Banner
state: Arizona
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: Fort Collins
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Ambulatory Care
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Marquette
country: United States
facility: DLP Marquette Physicians Practice
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saint Paul
country: United States
facility: HealthEast St Joseph's Hospital
state: Minnesota
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Asheville
country: United States
facility: Asheville Cardiology
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Cardiology - VIAA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Research Institute - Dallas
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute - Plano
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center - Cherry Hill
state: Washington
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre Coeur de Montreal
state: Quebec
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock University Hospitals
city: Blackpool
country: United Kingdom
facility: Blackpool, Fylde and Wyre Hospitals
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals
Study officials:
affiliation: Ohio State University
name: John Hummel, MD
role: PRINCIPAL_INVESTIGATOR
References: