atrial fibrillation atrrial fibrillation, transesophageal echocardiography, cardiac contrast-enhanced CT
Conditions
Interventions
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.
Thrombus Exclusion Test
Sponsors
Miyamoto Koji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| (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 | — |
Contacts
Public ContactKoji Miyamoto
National Cerebral and Cardiovascular Center
Outcome results
None listed