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

Medtronic Cardiac Ablation Solutions

Status: Terminated

Conditions: Persistent Atrial Fibrillation

Treatments: Device: Medtronic Phased RF Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01693120

VICTORY AF

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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199 participants in 1 patient group

Ablation

Experimental group

Description:

Phased RF ablation

Treatment:

Device: Medtronic Phased RF Ablation System