pulmonary valve disease
Conditions
Interventions
The PULSTAT(TM) Transcatheter Pulmonary Valve (TPV) System.
The PULSTA TPV is a self-expandable valve with flared-ends from knitted nitinol
wire backbone to adapt to the larger native right ventric
Sponsors
Taewoong Medical Co, Ltd Seoul, Korea
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Males and females aged >=16 years and weight >=30kg 2. Patients who are diagnosed with congenital or acquired heart disease with pulmonary valve disease and meet one or more of the following criteria: - Moderate or severe pulmonary valve regurgitation as assessed by echocardiography - Pulmonary valve stenosis with a mean gradient >35mmHg as assessed by echocardiography 3. Patients who have main pulmonary artery trunk of >=16 mm and
Exclusion criteria
Exclusion criteria: 1. Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation 2. When patients have a mechanical valve implanted previously in pulmonary position or who require concomitant repair of other cardiac valves 3. When it is impossible to insert the delivery system since the central veins to be approached for the TPV implantation are obstructed 4. Patients who have coronary artery compression confirmed by angiography 5. Patients have known severe allergy to Nickel 6. Patients have a known hypersensitivity to any anticoagulation therapy, or a hemorrhagic disease 7. Patients have an immunocompromising disease such as malignant tumor or bone marrow transplant, or are immunosuppressed by chemotherapy, immunosuppressant, etc. 8. Patients have a known or suspected active infectious disease requiring antibiotic treatment such as meningitis, endocarditis, etc. 9. Patients have a known hypersensitivity to contrast agent or have severe renal insufficiency. 10.Patients with absolute or relative contraindications for MRI 11. Patients have less than 6 months of life expectancy according to the investigator*s clinical judgment 12. When patients have participated in a clinical study with other investigational drug or device within the past 3 months 13. When TPV implantation is impossible by the investigator*s judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Procedural / Device related-serious adverse events at 6 months 2. Hemodynamic functional improvement at 6 months * Hemodynamic functional improvement is defined as mean RVOT gradient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Effectiveness endpoints are: * Procedural success at discharge (Visit 3) * Procedural success is defined as follows: o If TPV is implanted on the desired site o RV-PA peak systolic pressure gradient | — |
Countries
Germany, Italy, Netherlands, South Korea, Spain, Turkey
Contacts
Public ContactJMK Ko
Taewoong Medical Co, Ltd Seoul, Korea
Outcome results
None listed