Heart Disease
Conditions
Keywords
Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
Brief summary
The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
Detailed description
The PULSTA TPV is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (RVOT) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery system, which provides access to the right ventricular outflow tract through blood vessels. This registry will collect real-world clinical data on patients undergoing PULSTA TPV implantation at discharge and at 1 month, 6 months, and annually for up to 5 years after implantation.
Interventions
None listed
Sponsors
Taewoong Medical Co., Ltd.
Avania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with moderate to severe pulmonary regurgitation and/or pulmonary stenosis who undergo transcatheter pulmonary valve implantation using the PULSTA Transcatheter Pulmonary Valve(TPV). * Patients who are willing to participate in the study and who have voluntarily provided written informed consent.
Exclusion criteria
* Patients who have not signed informed consent * Patients who are contraindicated for the implantation per the device's Instructions for Use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural / device-related serious adverse events at 12 months | 12 months | — |
| Hemodynamic functional improvement at 12 months | 12 months | Hemodynamic functional improvement is defined as the achievement of both of the following criteria: * Mild or less pulmonary regurgitation measured by echocardiography AND * Mean Right Ventricular Outflow Tract(RVOT) pressure gradient measured by echocardiography ≤35mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 24 hours | Procedural success is defined as the Transcatheter Pulmonary Valve(TPV) implant in on the desired site, Right ventricle-Pulmonary artery (RV-PA) peak systolic pressure gradient \<35mmHg by cardiac catheterization, less mild pulmonary regurgitation by angiography, and freedom from explantation of the TPV at 24 hours following implantation. |
| Hemodynamic function at all follow-up visits | 5 years | Hemodynamic function will be assessed including: * Peak RVOT pressure gradient (by echocardiography) * Mean RVOT pressure gradient (by echocardiography) |
| Severity of pulmonary regurgitation (by echocardiography) | 5 years | Severity of pulmonary regurgitation will be measured by Doppler echocardiography and classified into none, trace/trivial, mild, moderate, and severe. |
| NYHA functional classification | 5 years | Clinical outcome will be assessed as per the New York Heart Association (NYHA) functional classification at all follow-up visits and will be compared to baseline values. |
| Freedom from death | 5 years | Frequency of all cause / cardiac / non-cardiac / procedural-related / device-related deaths during the 5-year follow-up period |
| Freedom from re-operation | 5 years | Reoperation is defined as open surgery that alters or adjusts, or replaces a previously implanted PULSTA |
| Freedom from catheter re-intervention | 5 years | Any interventional catheter procedure (e.g. balloon angioplasty) that alters or adjusts, or replaces a previously implanted PULSTA TPV |
| Freedom from TPV dysfunction | 5 years | Moderate or greater pulmonary regurgitation, clinically significant RVOT obstruction (mean RVOT gradient \>35 mmHg), or any valve-related event requiring re-intervention or re-operation |
| Incidence of procedural- and device-related adverse events | 5 years | — |
Countries
Germany, Italy, Poland, South Korea, Spain, Turkey (Türkiye)
Contacts
CONTACTJang Mi Ko
CONTACTHyejin Roh
STUDY_CHAIRMario Carminati
Niguarda Hospital
Outcome results
None listed