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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Medtronic Atrial Fibrillation Solutions
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01693120
First received: September 19, 2012
Last updated: September 5, 2014
Last verified: September 2014

September 19, 2012
September 5, 2014
November 2013
September 2015   (final data collection date for primary outcome measure)
Incidence of procedure and/or device related stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01693120 on ClinicalTrials.gov Archive Site
  • Post-procedural effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Acute procedural success [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Pulmonary vein stenosis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
  • Single procedure effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Atrial fibrillation burden reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Asymptomatic cerebral embolism [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Peri-procedural serious adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Peri-procedural stroke and transient ischemic attack [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Summarize adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Single procedure effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Atrial fibrillation burden reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Asymptomatic cerebral embolism [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Peri-procedural serious adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Peri-procedural stroke and transient ischemic attack [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Summarize adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
 
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
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
300
April 2017
September 2015   (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
  • Known sensitivities to heparin or warfarin
  • Contraindicated for MRI
  • Invasive cardiovascular procedure performed or planned within 3 month period of ablation procedure
Both
18 Years to 70 Years
No
Contact: Jen Lahr 763.526.2781 Jen.Lahr@medtronic.com
Contact: Jay Kelley 760.827.0076 jay.l.kelley@medtronic.com
United States,   Canada,   Germany,   Hungary,   Netherlands,   United Kingdom
 
NCT01693120
VICTORY AF
Yes
Medtronic Atrial Fibrillation Solutions
Medtronic Atrial Fibrillation Solutions
Not Provided
Principal Investigator: Greg Michaud, MD Brigham and Womens Hospital
Medtronic Atrial Fibrillation Solutions
September 2014

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