Comparison of cardiac contrast-enhanced CT and transesophageal echocardiography for exclusion of intra-atrial thrombus

JRCT ID: jRCT1052240211

Registered date:11/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: atrial fibrillation
• Date of first enrollment: 11/12/2024
• Target sample size: 420
• Study type: Interventional

Intervention(s)

CT group: Cardiac contrast-enhanced CT is performed to exclude intra-atrial thrombus in atrial fibrillation.
TEE group: TEE is performed to exclude intra-atrial thrombus in atrial fibrillation.

Outcome(s)

• Primary Outcome: Patient satisfaction with tests for the purpose of excluding blood clots (cardiac contrast CT or TEE) (11-point scale, included in the questionnaire about the test)

Secondary Outcome

(1) Questionnaire regarding the examination: anxiety, pain, discomfort, examination time, and next examination request
(2) Incidence of thromboembolism and transient ischemic attack within 4 weeks after ablation
(3) Incidence of cardiovascular events and all-cause mortality within 4 weeks after ablation
(4) Frequency of intra-atrial thrombus and subsequent resolution of thrombus on preablation cardiac contrast CT or TEE
(5) Whether intra-atrial thrombus was suspected on preablation cardiac contrast CT or TEE and whether it was evaluated on the other test and the results
(6) Renal function (Cr, CCr, eGFR), CRP, white blood cell count, neutrophil fraction, and body temperature after cardiac contrast CT or TEE (1-14 days)
(7) Renal function (Cr, CCr, eGFR) 4 weeks after ablation
(8) Examination time for cardiac contrast CT/ TEE
(9) Relationship between left atrial and left atrial appendage volume (left ventricular end-systole, mid-diastole, and end-diastole phases) and BNP, D-dimer, and echocardiographic findings at the time of obtaining consent in patients undergoing cardiac contrast-enhanced CT
(10) Success rate of pulmonary vein isolation
(11) Complications of ablation
(12) Adverse events
(13) Medical cost for examination to exclude thrombus prior to ablation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

(1) Patients aged 20 to 85 at the time of consent
(2) Patients undergoing catheter ablation for atrial fibrillation
(3) Patients whose written consent is obtained

Exclude criteria

(1) Pregnant women or patients who may be pregnant
(2) Patients who are already participating or will participate during the study period in interventional studies of drugs or medical devices
(3) Patients with active systemic infection
(4) Untreated or uncontrolled hyperthyroidism or hypothyroidism
(5) Patients with symptomatic carotid artery stenosis
(6) Patients who cannot use anticoagulants
(7) Severe renal dysfunction (eGFR <30mL/min/1.73m2)
(8) Allergy to contrast media
(9) Esophageal diverticulum, post-esophageal surgery, esophageal cancer, bleeding, ulcer, or tumor of stomach or esophagus, history of cervical or mediastinal radiation therapy
(10) Postoperative left atrial appendage occlusion
(11) Patients who are judged to be inappropriate to participate in this study by the principal investigator or a research partner.

Related Information

• Primary Sponsor: Miyamoto Koji
• Source(s) of Monetary Support: GE HealthCare, Investigator Sponsored Research,Cardiovascular Disease R&amp;D Expenses