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

This study has been terminated.
(The study was stopped solely based on lower than expected enrollment rate.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01693120
First received: September 19, 2012
Last updated: March 22, 2017
Last verified: March 2017

September 19, 2012
March 22, 2017
November 2013
February 7, 2017   (Final data collection date for primary outcome measure)
Incidence of procedure and/or device related stroke [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT01693120 on ClinicalTrials.gov Archive Site
  • Post-procedural effectiveness [ Time Frame: 6 months ]
  • Acute procedural success [ Time Frame: 30 minutes ]
  • Pulmonary vein stenosis [ Time Frame: 3 months ]
Same as current
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 Provided
Intervention Model: Single Group Assignment
Intervention Model Description:
Treatment with Phased RF Ablation System
Masking: No masking
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
300
December 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, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Hungary,   Netherlands,   United Kingdom
 
 
NCT01693120
VICTORY AF
Yes
Not Provided
No
Not Provided
Medtronic Atrial Fibrillation Solutions
Medtronic Atrial Fibrillation Solutions
Not Provided
Principal Investigator: John Hummel, MD Ohio State University
Medtronic Atrial Fibrillation Solutions
March 2017

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