Trial Condition(s):

Atrial Fibrillation

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)

Bayer Identifier:

16677

ClinicalTrials.gov Identifier:

NCT01928979

EudraCT Number:

Not Available

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
160
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
No Drug
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Medizinische Einrichtungen der Universität Bonn

Many Locations, Germany, 53105

Status
Completed
 
Locations

Hopital Saint Antoine - Paris

Many Locations, France, 75012

Status
Completed
 
Locations

Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego

Many Locations, Poland, 91-347

Status
Completed
 
Locations

MHAT National Cardiology Hospital EAD

Many Locations, Bulgaria, 1309

Status
Completed
 
Locations

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospit

Many Locations, Turkey, 34846

Status
Completed
 
Locations

Municipal Hospital N 4

Many Locations, Russia, 115093

Status
Completed
 
Locations

Regional Clinical Hospital

Many Locations, Ukraine, 65025

Status
Completed
 

Trial Design