Clinical trial NCT01928979: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: LA/LAA Thrombus
Atrial Fibrillation
Observation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Thrombus resolution (completely disappeared) rate confirmed on TEE.
timeFrame: after 3-12 weeks of SoC treatment or lost to follow up, whichever is later
Secondary outcomes:
measure: Stroke or non central nervous system (CNS) systemic thromboembolism rate
timeFrame: after 3-12 weeks of SoC treatment or lost to follow up, whichever is later
measure: All bleeding (major, non-major, unknown severity) rates
timeFrame: after 3-12 weeks of SoC treatment or lost to follow up, whichever is later
Other outcomes:
Locations:
city: Many Locations
country: Bulgaria
city: Many Locations
country: France
city: Many Locations
country: Germany
state: Nordrhein-Westfalen
city: Many Locations
country: Poland
city: Many Locations
country: Russian Federation
city: Many Locations
country: Turkey
city: Many Locations
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, Morandi E, van Eickels M, Cohen A. Rationale and design of a study exploring the efficacy of once-daily oral rivaroxaban (X-TRA) on the outcome of left atrial/left atrial appendage thrombus in nonvalvular atrial fibrillation or atrial flutter and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2015 Apr;169(4):464-71.e2. doi: 10.1016/j.ahj.2014.12.020. Epub 2015 Jan 6.