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Prospective Clinical Study to Evaluate the Efficacy and Safety of ‘Genoss Cardiac Output Thermodilution Catheter’ in Patients with Cardiovascular Disease

Prospective Clinical Study to Evaluate the Efficacy and Safety of ‘Genoss Cardiac Output Thermodilution Catheter’ in Patients with Cardiovascular Disease

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0004409
Enrollment
10
Registered
2019-10-31
Start date
2020-02-10
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Insert a pulmonary artery catheter (thermaldilution catheter) through the jugular vein in the neck area, either whole body or under partial anesthesia. The catheter is directed throug

Sponsors

Korea University Anam Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -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

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

MeasureTime frame
cardiac output measurement success rate

Secondary

MeasureTime frame
Device success rate;Procedural success rate; pulmonary arterial pressure measurement;central venous pressure measurement

Countries

Korea, Republic of

Contacts

Public ContactHoSung Son

Korea University Anam Hospital

hssonmd@gmail.com+82-2-920-6453

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026