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

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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 : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions

September 19, 2012
September 26, 2012
February 7, 2018
March 22, 2018
March 22, 2018
November 2013
February 7, 2017   (Final data collection date for primary outcome measure)
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
Incidence of procedure and/or device related stroke [ Time Frame: 30 days ]
Complete list of historical versions of study NCT01693120 on ClinicalTrials.gov Archive Site
  • 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
  • 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)
  • 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
  • Post-procedural effectiveness [ Time Frame: 6 months ]
  • Acute procedural success [ Time Frame: 30 minutes ]
  • Pulmonary vein stenosis [ Time Frame: 3 months ]
Not Provided
  • Single procedure effectiveness [ Time Frame: 6 months ]
  • Atrial fibrillation burden reduction [ Time Frame: 6 months ]
  • Asymptomatic cerebral embolism [ Time Frame: 30 days ]
  • Peri-procedural serious adverse events [ Time Frame: 30 days ]
  • Peri-procedural stroke and transient ischemic attack [ Time Frame: 30 days ]
  • Summarize adverse events [ Time Frame: 6 months ]
 
Evaluation of the Phased Radio Frequency Ablation System
Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Intervention Model Description:
Treatment with Phased RF Ablation System
Masking: None (Open Label)
Primary Purpose: Treatment
Persistent Atrial Fibrillation
Device: Medtronic Phased RF Ablation System
Phased RF ablation
Experimental: Ablation
Phased RF ablation
Intervention: Device: Medtronic Phased RF Ablation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
199
300
February 7, 2017
February 7, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Hungary,   Netherlands,   United Kingdom,   United States
Germany
 
NCT01693120
VICTORY AF
Yes
Not Provided
Plan to Share IPD: No
Medtronic Atrial Fibrillation Solutions
Medtronic Atrial Fibrillation Solutions
Not Provided
Principal Investigator: John Hummel, MD Ohio State University
Medtronic Atrial Fibrillation Solutions
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP