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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 (CLOT-AF)

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ClinicalTrials.gov Identifier: NCT01928979
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Atrial Fibrillation Other: no drug

Study Design

Study Type : Observational
Actual Enrollment : 160 participants
Time Perspective: Retrospective
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 Start Date : May 2013
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Other: no drug
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


Outcome Measures

Primary Outcome Measures :
  1. Thrombus resolution (completely disappeared) rate confirmed on TEE. [ Time Frame: after 3-12 weeks of SoC treatment or lost to follow up, whichever is later ]

Secondary Outcome Measures :
  1. Stroke or non central nervous system (CNS) systemic thromboembolism rate [ Time Frame: after 3-12 weeks of SoC treatment or lost to follow up, whichever is later ]
  2. All bleeding (major, non-major, unknown severity) rates [ Time Frame: after 3-12 weeks of SoC treatment or lost to follow up, whichever is later ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928979


Locations
Bulgaria
Many Locations, Bulgaria, 1309
France
Many Locations, France, 75012
Germany
Many Locations, Nordrhein-Westfalen, Germany, 53105
Poland
Many Locations, Poland, 91-347
Russian Federation
Many Locations, Russian Federation, 115093
Turkey
Many Locations, Turkey, 34846
Ukraine
Many Locations, Ukraine, 65025
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01928979     History of Changes
Other Study ID Numbers: 16677
NN1301 ( Other Identifier: company internal )
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by Bayer:
LA/LAA Thrombus
Atrial Fibrillation
Observation

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Anticoagulants