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

NCT01928979 | Completed

• 2 other identifiers: 16677NN1301
• Study Type: observational
• Target: 160
• Locations: 7 countries
• Sites: 7

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.

Conditions

Atrial Fibrillation

Keywords

LA/LAA Thrombus; Atrial Fibrillation; Observation

Outcome Measures

Primary Outcomes (1)

• Thrombus resolution (completely disappeared) rate confirmed on TEE.

  after 3-12 weeks of SoC treatment or lost to follow up, whichever is later

Secondary Outcomes (2)

• 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

Study Arms (1)

Group 1

Other: no drug

Interventions

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Men or women age ≥ 18 years at data recording
• Hemodynamically stable nonvalvular AF or atrial flutter
• Documented LA/ LA thrombus on TEE

You may not qualify if:

• Valvular AF ( ESC 2012 definition)
• History of cardiac thrombus confirmed on TEE
• Intracardiac tumors, e.g. atrial myxoma
• Active endocarditis

Sponsors & Collaborators

• Bayer: lead

Study Sites (7)

Unknown Facility

Many Locations, 1309, Bulgaria

Location

Unknown Facility

Many Locations, 75012, France

Location

Unknown Facility

Many Locations, North Rhine-Westphalia, 53105, Germany

Location

Unknown Facility

Many Locations, 91-347, Poland

Location

Unknown Facility

Many Locations, 115093, Russia

Location

Unknown Facility

Many Locations, 34846, Turkey (Türkiye)

Location

Unknown Facility

Many Locations, 65025, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 25819852 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 27, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

DE (1); TU (1); UA (1); PL (1); BU (1); FR (1); RU (1)