Ultrasound imaging of the heart and the large vessels of the heart and intracardiac anatomy
Conditions
Interventions
Test group:single-use intracardiac ultrasound imaging catheter, portable digital color ultrasound diagnostic instrument, three-dimensional cardiac electrophysiology calibration system
Control group:3D Diagnostic Ultrasound catheter SOUNDSTAR 3D Diagnostic Ultrasound catheter and its accompanying ultrasound system
Sponsors
The First Affiliated Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18 years old<=age<=80 years old, gender is not limited; 2.Patients who plan to undergo arrhythmia interventional surgery and need to complete ultrasound imaging of the heart, cardiac large vessels, and intracardiac anatomy; 3.Fully understand the treatment plan, and voluntarily sign the informed consent form, and be willing to undergo the examination, surgery and follow-up required by the plan.
Exclusion criteria
Exclusion criteria: 1.Patients with thromboembolic disease; 2.Angina CCS grade IV or NYHA grade IV; 3.Those with definite acute cerebrovascular diseases (including cerebral hemorrhage, stroke, transient ischemic attack) in the past 1 month; 4.Those who have had cardiovascular events in the past 3 months (including acute myocardial infarction, heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy); 5.Patients with acute or severe systemic infection; 6.Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases, which in the opinion of the investigator may interfere with the treatment, evaluation and compliance of this trial; 7.Patients with obvious bleeding tendency, hypercoagulable state and severe hematologic diseases; 8.Patients who are participating in other clinical trials; 9.Patients who have other conditions that the investigator considers inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ultrasound image quality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical success rate;Ultrasound catheter magnetic localization accuracy;Evaluation of Doppler flow imaging;Evaluation of test group catheter performance; | — |
Countries
China
Contacts
Public ContactChu Huimin
The First Affiliated Hospital of Ningbo University
Outcome results
None listed