Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 9:42 PM
Study NCT ID:
NCT01680757
Status:
WITHDRAWN
Last Update Posted:
2013-02-25
First Post:
2012-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Multicenter Registry of Permanent Ligation Approximation Closure Exclusion of the Left Atrial Appendage in Patients With Atrial Fibrillation III (PLACE III)
Status:
WITHDRAWN
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study has been withdrawn prior to enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLACE III
Brief Summary:
This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. This study will enroll 100 participant, who will receive the LAA ligation study treatment. The objective of this registry is to assess the effectiveness of permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard anticoagulation therapy. The results of the study will be used to assess outcomes within the first year, post-treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: