Efficacy of dobutamine infusion for exclusion of left atrial appendage thrombus

JRCT ID: jRCTs031220544

Registered date:27/12/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 25/01/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Dobutamine injection 5-20 microgram / kg / min intravenously for up to 10 minutes

Outcome(s)

• Primary Outcome: Changes in the grade of spontaneous echo contrast in LA and LAA before and after dobutamine infusion evaluated by the doctor performed TEE

Secondary Outcome

Changes 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 maximum: Not applicable
• Gender: Both

Include criteria

Inclusion 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 criteria

Exclusion 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

• Primary Sponsor: Machino Tomoko
• Source(s) of Monetary Support: University of Tsukuba