Suspended

VICTORY-AFEvaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation

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What is being tested

Medtronic Phased RF Ablation System

Device
Who is being recruted

Arrhythmias, Cardiac+3

+ Cardiovascular Diseases

+ Heart Diseases

From 18 to 75 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2013
See protocol details

Summary

Principal SponsorMedtronic Cardiac Ablation Solutions
Last updated: February 13, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01693120
Principal SponsorMedtronic Cardiac Ablation Solutions
Last updated: February 13, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

199 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAtrial Fibrillation

Criteria

2 inclusion criteria required to participate
Failure of at least one anti-arrhythmic drug
History of symptomatic persistent or long-standing persistent atrial fibrillation
5 exclusion criteria prevent from participating
Contraindicated for MRI
Invasive cardiovascular procedure performed or planned within 3 month period of ablation procedure
Known sensitivities (or allergy) to heparin, warfarin, contrast media
Prior ablation in left atrium for AF
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Phased RF ablation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 40 locations

Phoenix Cardiovascular - Banner

Phoenix, United StatesOpen Phoenix Cardiovascular - Banner in Google Maps

Hoag Hospital

Newport Beach, United States

Medical Center of the Rockies

Fort Collins, United States

Mayo Clinic

Jacksonville, United States
Suspended40 Study Centers