Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study

PHASE3CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2011

Conditions
Atrial Fibrillation
Interventions
DEVICE

Cardioblate System Surgical Ablation System

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.

PROCEDURE

Surgical RF Ablation

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.

Trial Locations (15)

10075

Lenox Hill Hospital, New York

19104

Hospital of University of Pennsylvania, Philadelphia

22042

Inova Fairfax, Falls Church

33701

Cardiac Surgical Associates of Florida, St. Petersburg

44195

Cleveland Clinic Foundation, Cleveland

53515

Aurora St. Luke's Medical Center, Milwaukee

55902

Mayo/St. Mary's Hospital, Rochester

60611

Northwestern Memorial Hospital, Chicago

63110

Washington University School of Medicine, St Louis

85260

Southwest Heart and Lung, Phoenix

87102

New Mexico Heart Institute, Albuquerque

90033

University of Southern California, Los Angeles

92270

Eisenhower Medical Center, Palm Springs

94520

East Bay Cardiovascular & Thoracic Associates, Concord

07631

Englewood Hospital and Medical Center, Englewood

Sponsors
All Listed Sponsors
lead

Medtronic Cardiovascular

INDUSTRY

NCT00431834 - Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study | Biotech Hunter | Biotech Hunter