search
Back to results

Evaluation of the Phased Radio Frequency Ablation System (VICTORY-AF)

Primary Purpose

Persistent Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic Phased RF Ablation System
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring ablation, atrial fibrillation, Radio frequency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Cardiovascular - Banner
  • Hoag Hospital
  • Medical Center of the Rockies
  • Mayo Clinic
  • St. Vincent's Ambulatory Care
  • Tallahassee Research Institute
  • Piedmont Heart Institute
  • Emory University
  • Northeast Georgia Heart Center
  • Northwestern University
  • Iowa Heart Center
  • University of Iowa
  • Baptist Health Lexington
  • University of Michigan
  • Spectrum Health Hospitals
  • DLP Marquette Physicians Practice
  • William Beaumont Hospital
  • HealthEast St Joseph's Hospital
  • Jersey Shore University Medical Center
  • Asheville Cardiology
  • Cleveland Clinic
  • The Ohio State University
  • Doylestown Cardiology - VIAA
  • Hospital of the University of Pennsylvania
  • Geisinger Wyoming Valley Medical Center
  • Baylor Research Institute - Dallas
  • St. Luke's Episcopal Hospital
  • Baylor Research Institute - Plano
  • University of Virginia Medical Center
  • Inova Fairfax Hospital
  • Swedish Medical Center - Cherry Hill
  • Southlake Regional Health Centre
  • McGill University Health Centre
  • Hopital du Sacre Coeur de Montreal
  • Debreceni Egyetem
  • Catharina Ziekenhuis
  • St. Antonius Ziekenhuis
  • Basildon and Thurrock University Hospitals
  • Blackpool, Fylde and Wyre Hospitals
  • Newcastle Upon Tyne Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ablation

Arm Description

Phased RF ablation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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)
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

Full Information

First Posted
September 19, 2012
Last Updated
September 17, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
search

1. Study Identification

Unique Protocol Identification Number
NCT01693120
Brief Title
Evaluation of the Phased Radio Frequency Ablation System
Acronym
VICTORY-AF
Official Title
Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped solely based on lower than expected enrollment rate.
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 7, 2017 (Actual)
Study Completion Date
February 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
ablation, atrial fibrillation, Radio frequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Treatment with Phased RF Ablation System
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ablation
Arm Type
Experimental
Arm Description
Phased RF ablation
Intervention Type
Device
Intervention Name(s)
Medtronic Phased RF Ablation System
Intervention Description
Phased RF ablation
Primary Outcome Measure Information:
Title
Number of Participants With Procedure and/or Device Related Stroke
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
6-month Post-procedure Effectiveness
Description
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
Time Frame
6 months
Title
Number of Participants With Acute Procedural Success
Description
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)
Time Frame
30 minutes
Title
Number of Participants With Pulmonary Vein Stenosis
Description
Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hummel, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Cardiovascular - Banner
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Hoag Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Medical Center of the Rockies
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
St. Vincent's Ambulatory Care
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northeast Georgia Heart Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
DLP Marquette Physicians Practice
City
Marquette
State/Province
Michigan
ZIP/Postal Code
49855
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
HealthEast St Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Asheville Cardiology
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Doylestown Cardiology - VIAA
City
Doylestown
State/Province
Pennsylvania
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Baylor Research Institute - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Research Institute - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Swedish Medical Center - Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Hopital du Sacre Coeur de Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Debreceni Egyetem
City
Debrecen
Country
Hungary
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Basildon and Thurrock University Hospitals
City
Basildon
Country
United Kingdom
Facility Name
Blackpool, Fylde and Wyre Hospitals
City
Blackpool
Country
United Kingdom
Facility Name
Newcastle Upon Tyne Hospitals
City
Newcastle Upon Tyne
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Phased Radio Frequency Ablation System

We'll reach out to this number within 24 hrs