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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: no drug

• Registration Number: NCT01928979
• Lead Sponsor: Bayer

Brief Summary

Thrombus outcome data will be collected retrospectively during 2011-2012 as a historical baseline of SoC with oral VKA (Vitamin K Antagonist(s) 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-27
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-21
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Men or women age ≥ 18 years at data recording
• Hemodynamically stable nonvalvular AF or atrial flutter
• Documented LA/ LA thrombus on TEE

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Exclusion Criteria

• Valvular AF ( ESC 2012 definition)
• History of cardiac thrombus confirmed on TEE
• Intracardiac tumors, e.g. atrial myxoma
• Active endocarditis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	no drug	-

Primary Outcome Measures

Name	Time	Method
Thrombus resolution (completely disappeared) rate confirmed on TEE.	after 3-12 weeks of SoC treatment or lost to follow up, whichever is later

Secondary Outcome Measures

Name	Time	Method
Stroke or non central nervous system (CNS) systemic thromboembolism rate	after 3-12 weeks of SoC treatment or lost to follow up, whichever is later
All bleeding (major, non-major, unknown severity) rates	after 3-12 weeks of SoC treatment or lost to follow up, whichever is later