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| ID | Type | Description | Link |
|---|---|---|---|
| NN1301 | Other Identifier | company internal |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no drug | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombus resolution (completely disappeared) rate confirmed on TEE. | after 3-12 weeks of SoC treatment or lost to follow up, whichever is later |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | 1309 | Bulgaria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25819852 | Derived | 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. |
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| Many Locations |
| 75012 |
| France |
| Many Locations | North Rhine-Westphalia | 53105 | Germany |
| Many Locations | 91-347 | Poland |
| Many Locations | 115093 | Russia |
| Many Locations | 34846 | Turkey (Türkiye) |
| Many Locations | 65025 | Ukraine |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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