Prospective Clinical Study to Evaluate the Efficacy and Safety of ‘Genoss Cardiac Output Thermodilution Catheter’ in Patients with Cardiovascular Disease
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0004409
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Of the five clinical trial subjects, three reached the target location and hemodynamic data were measured, but two did not reach the target location and the clinical trial was discontinued. Improvements are needed to ensure that the catheter can reach the target location.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 5
Over 19 years, under 80 years of age
-Patients undergoing heart surgery with aortic valve stenosis, aortic valve insufficiency, mitral valve stenosis, mitral valve insufficiency, acute myocardial infarction, unstable angina, stability angina, aortic aneurysm, aortic dissection, etc. Patients who need to understand the condition of the patient due to unstable hemodynamics
-Patients who have voluntarily decided and agreed to participate in this clinical trial
-Patients who are operated on for endocarditis
-In case the tester determines that it is not suitable for this clinical trial or that participation in the study may increase the risk.
-Patients who are judged unable to participate in this study as pregnant or conceivable patients
-If the thermodilution catheter does not reach the measurement position
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cardiac output measurement success rate
- Secondary Outcome Measures
Name Time Method Device success rate;Procedural success rate; pulmonary arterial pressure measurement;central venous pressure measurement