The PULSTA(TM) Transcatheter Pulmonary Valve (TPV) Pre-Approval Study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

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 <=30 mm
4. Patients whom are willing to participate in the study and willing to comply
with the required treatments, procedures and attend all follow-up evaluations.
5. Patients who have been informed of the nature of the study, and have
voluntarily provided written informed consent

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Procedural / Device related-serious adverse events at 6 months<br /><br>2. Hemodynamic functional improvement at 6 months<br /><br><br /><br>* Hemodynamic functional improvement is defined as mean RVOT gradient <=30 mmHg<br /><br>by continuous wave Doppler and a pulmonary regurgitant fraction <20% by cardiac<br /><br>MRI </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Effectiveness endpoints are:<br /><br>* Procedural success at discharge (Visit 3)<br /><br>* Procedural success is defined as follows:<br /><br>o If TPV is implanted on the desired site<br /><br>o RV-PA peak systolic pressure gradient <35mmHg on cardiac catheterization<br /><br>o If pulmonary regurgitation is < mild as assessed by angiography or<br /><br>echocardiography<br /><br>o If TPV is not removed within 24 hours following implantation<br /><br>* Hemodynamic function at all follow-up visits (Visits 3-10)<br /><br>o Peak RVOT pressure gradient (by TTE)<br /><br>o Mean RVOT pressure gradient (by TTE)<br /><br>o RV end-diastolic volume index (RVEDV, by cardiac MRI at Visit 5)<br /><br>* Pulmonary Regurgitant Fraction (PRF, by cardiac MRI at Visit 5)<br /><br>* Severity of pulmonary regurgitation (Doppler echocardiography, Visit 1 and<br /><br>Visit 3-10)<br /><br>* NYHA functional classification (classification scale, Visit 1 and Visit 3-10) </p><br>