Ignite Creation Date:
2024-05-06 @ 1:54 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01928979
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2013-08-22
Brief Title:
Retrospective Registry Providing Baseline Data on the Outcome of Left Atrial LA or LA Appendage LAA Thrombus in Patients With Nonvalvular Atrial Fibrillation AF or Atrial Flutter After Standard of Care SoC Anticoagulant Therapy
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Retrospective Registry Providing Baseline Data on the Outcome of Left Atrial LA or LA Appendage LAA Thrombus in Patients With Nonvalvular Atrial Fibrillation AF or Atrial Flutter After Standard of Care SoC Anticoagulant Therapy
Status:
COMPLETED
Status Verified Date:
2014-12
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:
CLOT-AF
Brief Summary:
Thrombus outcome data will be collected retrospectively during 2011-2012 as a historical baseline of SoC with oral VKA Vitamin K Antagonists for the treatment of patients with nonvalvular AF or atrial flutter documented with LA LAA thrombi on transesophag-eal echocardiography TEE
The study is a company-sponsored global multi-center retrospective non-interventional study Patients who suffered from hemodynamically stable nonvalvular AF or atrial flutter and had a diagnosed LA LAA thrombus between January 1st 2011 and December 31st 2012 will be identified through screening and review of medical records and included in the registry Retrospective patient data will be collected from May 2nd 2013 to May 2nd 2014 The observation of each patient will cover the period from the diagnosis of an LA LAA thrombus until the end-of-treatment TEE following the 3-12 week SoC anticoagulation AC therapy If no end-of-treatment TEE has been performed during 3-12 weeks of AC therapy the observational period will end at 12 weeks after diagnosis at the latest If more than one TEE was performed during treatment the thrombus outcome will be collected from the last TEE performed within 12 weeks of treatment start
The study is a company-sponsored global multi-center retrospective non-interventional study Patients who suffered from hemodynamically stable nonvalvular AF or atrial flutter and had a diagnosed LA LAA thrombus between January 1st 2011 and December 31st 2012 will be identified through screening and review of medical records and included in the registry Retrospective patient data will be collected from May 2nd 2013 to May 2nd 2014 The observation of each patient will cover the period from the diagnosis of an LA LAA thrombus until the end-of-treatment TEE following the 3-12 week SoC anticoagulation AC therapy If no end-of-treatment TEE has been performed during 3-12 weeks of AC therapy the observational period will end at 12 weeks after diagnosis at the latest If more than one TEE was performed during treatment the thrombus outcome will be collected from the last TEE performed within 12 weeks of treatment start
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NN1301 | OTHER | company internal | None |