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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01928979
First received: August 22, 2013
Last updated: December 21, 2014
Last verified: December 2014
  Purpose

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 Intervention
Atrial Fibrillation Other: no drug

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]

Enrollment: 160
Study Start Date: May 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: August 22, 2013
Last Updated: December 21, 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

ClinicalTrials.gov processed this record on June 28, 2017