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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 7, 2014
Last verified: August 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: April 2017
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 36 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: August 7, 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 August 21, 2014