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OpenTrials
Completed

NCT Number: 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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: CLOT-AF

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2013
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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