Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-03-01 @ 1:03 AM
Study NCT ID:
NCT02309268
Status:
WITHDRAWN
Last Update Posted:
2015-06-15
First Post:
2014-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Appendage Closure Prospective Observational Study
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
LARIAT: Atrial Appendage Closure Prospective Observational Study
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The principal linvestigator decided not to continue the registry. No patient were enrolled. CLosure to the registry was done October 2014
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LARIAT
Brief Summary:
The purpose of this research is to monitor how well patients do after surgery for treatment of left atrial appendage (LAA).
Detailed Description:
Patients will be followed in an observational study. We propose to do a single follow-up TEE at 3 to 6 months (this is standard of care) to confirm LAA (left atrial appendage) occlusion. The TEE is not mandatory (this is not a clinical trial), but will be strongly recommended to patients to confirm the efficacy of treatment. This will help confirm whether patients may safely remain off anticoagulation. The risks of TEE are a less than 1 in 1000 risk of death, and a 1% or less risk of a major complication, such as esophageal perforation.
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?: