Evaluation of the Phased Radio Frequency Ablation System

NCT ID: NCT01693120

Last Updated: 2025-02-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-02-07

Brief Summary

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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.

Detailed Description

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Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Treatment with Phased RF Ablation System
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ablation

Phased RF ablation

Group Type EXPERIMENTAL

Medtronic Phased RF Ablation System

Intervention Type DEVICE

Phased RF ablation

Interventions

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Medtronic Phased RF Ablation System

Phased RF ablation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Hummel, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Phoenix Cardiovascular - Banner

Phoenix, Arizona, United States

Site Status

Hoag Hospital

Newport Beach, California, United States

Site Status

Medical Center of the Rockies

Fort Collins, Colorado, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

St. Vincent's Ambulatory Care

Jacksonville, Florida, United States

Site Status

Tallahassee Research Institute

Tallahassee, Florida, United States

Site Status

Piedmont Heart Institute

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Northeast Georgia Heart Center

Gainesville, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Iowa Heart Center

Des Moines, Iowa, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Site Status

DLP Marquette Physicians Practice

Marquette, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

HealthEast St Joseph's Hospital

Saint Paul, Minnesota, United States

Site Status

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Site Status

Asheville Cardiology

Asheville, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Doylestown Cardiology - VIAA

Doylestown, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Baylor Research Institute - Dallas

Dallas, Texas, United States

Site Status

St. Luke's Episcopal Hospital

Houston, Texas, United States

Site Status

Baylor Research Institute - Plano

Plano, Texas, United States

Site Status

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Swedish Medical Center - Cherry Hill

Seattle, Washington, United States

Site Status

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Site Status

McGill University Health Centre

Montreal, Quebec, Canada

Site Status

Hopital du Sacre Coeur de Montreal

Montreal, Quebec, Canada

Site Status

Debreceni Egyetem

Debrecen, , Hungary

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status

Basildon and Thurrock University Hospitals

Basildon, , United Kingdom

Site Status

Blackpool, Fylde and Wyre Hospitals

Blackpool, , United Kingdom

Site Status

Newcastle Upon Tyne Hospitals

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States Canada Hungary Netherlands United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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VICTORY AF

Identifier Type: -

Identifier Source: org_study_id

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