Overview

This trial has been terminated.

Condition persistent atrial fibrillation
Treatment medtronic phased rf ablation system
Sponsor Medtronic Atrial Fibrillation Solutions
Start date November 2013
End date February 2017
Trial size 300 participants
Trial identifier NCT01693120, VICTORY AF

Summary

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Intervention model description treatment with phased rf ablation system
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Phased RF ablation
medtronic phased rf ablation system
Phased RF ablation

Primary Outcomes

Measure
Incidence of procedure and/or device related stroke
time frame: 30 days

Secondary Outcomes

Measure
Post-procedural effectiveness
time frame: 6 months
Acute procedural success
time frame: 30 minutes
Pulmonary vein stenosis
time frame: 3 months

Eligibility Criteria

All participants from 18 years up to 75 years old.

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

Additional Information

Official title Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation
Principal investigator John Hummel, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Medtronic Atrial Fibrillation Solutions.