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

This study is currently recruiting participants.
Verified March 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: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Persistent Atrial Fibrillation
Device: Medtronic Phased RF Ablation System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:
  • Incidence of procedure and/or device related stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: November 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ablation
Phased RF ablation
Device: Medtronic Phased RF Ablation System
Phased RF ablation

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  • Known sensitivities to heparin or warfarin
  • Contraindicated for MRI
  • Invasive cardiovascular procedure performed or planned within 3 month period of ablation procedure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693120

Contacts
Contact: Jen Lahr 763.526.2781 Jen.Lahr@medtronic.com
Contact: Jay Kelley 760.827.0076 jay.l.kelley@medtronic.com

  Show 30 Study Locations
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Investigators
Principal Investigator: Greg Michaud, MD Brigham and Womens Hospital
  More Information

No publications provided

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01693120     History of Changes
Other Study ID Numbers: VICTORY AF
Study First Received: September 19, 2012
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Atrial Fibrillation Solutions:
ablation
atrial fibrillation
Radio frequency

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014