Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
Detailed description
The TPV is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional right ventricular ourflow tract (RVOT) requiring treatment for severe pulmonary regurgitation and/or RVOT conduit obstruction. Consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post TPV implantation.
Interventions
DEVICEPulsta® Transcatheter Pulmonary Valve (TPV) Replacement
Pulsta® Transcatheter Pulmonary Valve Replacement
Sponsors
Taewoong Medical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body weight greater than or equal to 30 kilograms * Pulmonary regurgitation ≥moderate pulmonary regurgitation (PR) (≥3+) or RVOT conduit obstruction with mean gradient \>35mmHg by echocardiography * pulmonary artery annulus or in situ conduit size of ≥16 and ≤26mm * Patient willing to provide written informed consent and comply with follow-up requirements
Exclusion criteria
* Pre-existing mechanical heart valve in any position * Obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart) * Coronary artery compression * A known hypersensitivity to Aspirin or Heparin * Immunosuppressive disease * Active infectious disease (e.g. endocarditis, meningitis) * Estimated survival less than 6 months * Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic functional improvement at 6month | 6 months | Hemodynamic functional improvement is defined as mean RVOT gradient ≤30 mmHg by continuous wave doppler, and a pulmonary regurgitant fraction \<20% by cardiac magnetic resonance (MR). |
| Procedural / Device related serious adverse events at 6month | 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of pulmonary regurgitation | 5 years | — |
| New York Heart Association (NYHA) functional classification | 5 years | — |
| Stent fracture | 5 years | Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy). |
| Catheter reintervention on TPV | 5 years | — |
| Procedural success | 5 days | Procedural success is defined as the TPV implant within desired position, Right ventricle-Pulmonary artery (RV-PA) peak systolic pressure gradient \<35mmHg by catheter, less mild pulmonary regurgitation by angiography, and freedom from explantation of the TPV at 24 hours post-implant. |
| Procedural / Device related serious adverse events | 5 years | — |
| Death (all cause / procedural / device-related) | 5 years | — |
| Other adverse events | 5 years | — |
| Pulmonary regurgitant fraction | 6 months | Pulmonary regurgitant fraction will be measured by cardiac MRI. |
| Reoperation | 5 years | — |
| Hemodynamic function | 5 years | Hemodynamic function will be measured including peak RVOT pressure gradient, mean RVOT pressure gradient, RV-PA pressure gradient, RV pressure, cardiac output, cardiac index, RV end-diastolic volume by echocardiography, cardiac MR, or catheterization. |
Countries
South Korea
Outcome results
None listed