NL-OMON49198RecruitingNot Applicable
The PULSTA(TM) Transcatheter Pulmonary Valve (TPV) Pre-Approval Study - PULSTA TPV Study
Taewoong Medical Co., Ltd.0 sites10 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 16 to 99 (—)
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,
- •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
Investigators
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