PULSTA TPV Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Disease. Basic parameters: from 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Italy, Poland, South Korea, Spain +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Observational Study on the Clinical Outcomes and Long-term Follow-up of the PULSTATM Transcatheter Pulmonary Valve (TPV)
Overview
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.
Primary outcome measures
- Procedural / device-related serious adverse events at 12 months [Time frame: 12 months]
- Hemodynamic functional improvement at 12 months [Time frame: 12 months]
Secondary outcome measures (9)
- Procedural success [Time frame: 24 hours]
- Hemodynamic function at all follow-up visits [Time frame: 5 years]
- Severity of pulmonary regurgitation (by echocardiography) [Time frame: 5 years]
- NYHA functional classification [Time frame: 5 years]
- Freedom from death [Time frame: 5 years]
- Freedom from re-operation [Time frame: 5 years]
- Freedom from catheter re-intervention [Time frame: 5 years]
- Freedom from TPV dysfunction [Time frame: 5 years]
- Incidence of procedural- and device-related adverse events [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Patients with moderate to severe pulmonary regurgitation and/or pulmonary stenosis who undergo transcatheter pulmonary valve implantation using the PULSTA 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 3 centers
- Bucheon Sejong Hospital — Bucheon-si
- Seoul National University Hospital (Seoul) — Seoul
- Severance Hospital (Seoul) — Seoul
Turkey (Türkiye) · 2 centers
- Koc University Hospital (Istanbul) — Istanbul
- Siyami Ersek Hospital (Istanbul) — Istanbul
Germany · 1 center
- Deutsches Herzzentrum München — Munich
Italy · 1 center
- Ospedale Niguarda (Milano) — Milan
Poland · 1 center
- Polish Mother's memorial hospital — Lodz
Spain · 1 center
- La Paz Hospital (Madrid) — Madrid
Identifiers
NCT: NCT07747207 · TWTPV-ER1001