Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431834
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2007-02-02
Brief Title:
Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation CURE-AF Study
Sponsor:
Medtronic Cardiovascular
Organization:
Medtronic Cardiovascular
Study Overview
Official Title:
Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation CURE-AFPermanent Study
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None