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 is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01928979
First received: August 22, 2013
Last updated: August 7, 2014
Last verified: August 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: May 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01928979     History of Changes
Other Study ID Numbers: 16677, NN1301
Study First Received: August 22, 2013
Last Updated: August 7, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency
Bulgaria: Ethics committee
Bulgaria: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
France: The Commission nationale de l’informatique et des libertés
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Germany: Federal Office for Radiation Protection
Germany: German Institute of Medical Documentation and Information
Germany: Ministry of Health
Germany: Ministry of Work, Health and Social Affairs in North Rhine-Westph
Germany: Paul-Ehrlich-Institut
Germany: The Bavarian State Ministry of the Environment and Public Health
Poland: Ethics Committee
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: National Institute of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Turkey: Ethics Committee
Turkey: Ministry of Health
Ukraine: Ethics Committee
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014