Congenital Heart Defects Clinical Trial
Official title:
A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Implantation of Transcatheter Pulmonary Valve (TPV) for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease
Verified date | January 2023 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 25, 2021 |
Est. primary completion date | April 14, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility | Inclusion Criteria: - Age greater than or equal to 10 years of age - 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 =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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul | Haehak-ro Jongno-gu |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedural success | Procedural success is defined as the TPV implant within desired position, 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. | 5day | |
Primary | Hemodynamic functional improvement at 6month | 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). | 6 month | |
Primary | Procedural / Device related serious adverse events at 6month | 6 month | ||
Secondary | Hemodynamic function | 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. | 5 year | |
Secondary | Severity of pulmonary regurgitation | 5year | ||
Secondary | Pulmonary regurgitant fraction | 5year | ||
Secondary | New York Heart Association (NYHA) functional classification | 5 year | ||
Secondary | Stent fracture | 5 year | ||
Secondary | Catheter reintervention on TPV | 5 year | ||
Secondary | Reoperation | 5 year | ||
Secondary | Procedural / Device related serious adverse events | 5 year | ||
Secondary | Death (all cause / procedural / device-related) | 5 year | ||
Secondary | Other adverse events | 5 year |
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