Study:
Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Permanent Study
Rationale:
n/a
Purpose:
This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the
outcome of patients with atrial fibrillation (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 graft
(CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate
Surgical Ablation System can safely and effectively treat permanent AF patients.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Atrial Fibrillation |
Device: Cardioblate System Surgical Ablation System Procedure: Surgical RF Ablation |
Phase 3 |
Verified by
Medtronic Cardiovascular
October, 2012
Sponsored by: Medtronic Cardiovascular
Information provided by: Medtronic Cardiovascular
ClinicalTrials.gov identifier: NCT00431834
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Thoralf Sundt, MD., Principal Investigator