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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031220544

Registered date:27/12/2022

Efficacy of dobutamine infusion for exclusion of left atrial appendage thrombus

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAtrial fibrillation
Date of first enrollment25/01/2023
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Dobutamine injection 5-20 microgram / kg / min intravenously for up to 10 minutes

Outcome(s)

Primary OutcomeChanges in the grade of spontaneous echo contrast in LA and LAA before and after dobutamine infusion evaluated by the doctor performed TEE
Secondary OutcomeChanges in the grade of spontaneous echo contrast in LA and LAA before and after isoprenaline infusion evaluated by other independent investigator Changes in the LAA blood flow velocity, LAA wall motion velocity, LAA emptying fraction, left ventricular ejection fraction before and after isoprenaline infusion Number of cases for which the presence or absence of LAA thrombus could be diagnosed after isoprenaline infusion, and prevalence of LAA thrombus

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaInclusion criteria for the first step 1)Patients with valvular or non-valvular atrial fibrillation (AF) 2)Patients undergoing transesophageal echocardiography (TEE) for evaluation of intracardiac thrombus before catheter ablation for AF, percutaneous left atrial appendage (LAA) occlusion, percutaneous mitral valve commissurotomy, and electrical cardioversion, or patients suspected cardiogenic stroke and undergoing TEE to evaluate intracardiac thrombus 3)Patients with a CHADS2 score of 1 or higher 4)Patients receiving anticoagulant therapy 5)Men and women over 20 years old 6)Patients with written informed consent Inclusion criteria for the second step 7)Patients with severe blood flow stasis (spontaneous echo contrast grade of 3 or 4) in left atrium (LA) and LAA
Exclude criteriaExclusion criteria for the first step 1) Patients with past history of LAA occlusion or resection 2) Patients with systolic blood pressure of 80 mmHg or less or 180 mmHg or more before the start of TEE 3) Patients with heart rate (measured by the average method) of 100 bpm or more before the start of TEE 4) Patients receiving catecholamines 5) Patients with a history of allergic reactions to dobutamine 6) Patients with hypertrophic cardiomyopathy who have intraventricular obstruction with a maximum pressure gradient of 30 mmHg or more 7) Patients with unstable angina 8) Patients with disorientation, quadriplegia, dysarthria, and visual field impairment 9) Women who are pregnant or may become pregnant 10) Patients who are judged inappropriate by the researcher Exclusion criteria for the second step 11) Patients with obvious LAA thrombus without infusion of dobutamine 12) Patients with systolic blood pressure of 80 mmHg or less or 180 mmHg or more before the start of dobutamine infusion 13) Patients with heart rate (measured by the average method) of 100 bpm or more before the start of dobutamine infusion

Related Information

Contact

Public contact
Name Tomoko Machino
Address 1-1-1 Tennodai, Tsukuba, Ibaraki Ibaraki Japan 305-8575
Telephone +81-29-853-3143
E-mail tomoko-machino@md.tsukuba.ac.jp
Affiliation University of Tsukuba
Scientific contact
Name Tomoko Machino
Address 2-1-1 Amakubo, Tsukuba, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3143
E-mail tomoko-machino@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital