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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01693120
Recruitment Status : Terminated (The study was stopped solely based on lower than expected enrollment rate.)
First Posted : September 26, 2012
Results First Posted : March 22, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Device: Medtronic Phased RF Ablation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Treatment with Phased RF Ablation System
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation
Study Start Date : November 2013
Actual Primary Completion Date : February 7, 2017
Actual Study Completion Date : February 7, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ablation
Phased RF ablation
Device: Medtronic Phased RF Ablation System
Phased RF ablation




Primary Outcome Measures :
  1. Number of Participants With Procedure and/or Device Related Stroke [ Time Frame: 30 days ]
    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 :
  1. 6-month Post-procedure Effectiveness [ Time Frame: 6 months ]
    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

  2. Number of Participants With Acute Procedural Success [ Time Frame: 30 minutes ]
    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)

  3. Number of Participants With Pulmonary Vein Stenosis [ Time Frame: 3 months ]
    Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693120


Locations
Show Show 40 study locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: John Hummel, MD Ohio State University
  Study Documents (Full-Text)

Documents provided by Medtronic Cardiac Rhythm and Heart Failure:
Study Protocol  [PDF] November 21, 2014
Statistical Analysis Plan  [PDF] July 18, 2013

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01693120    
Other Study ID Numbers: VICTORY AF
First Posted: September 26, 2012    Key Record Dates
Results First Posted: March 22, 2018
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
ablation
atrial fibrillation
Radio frequency
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes