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
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is observational and not yet recruiting — how soon do you expect it to open, and would waiting for it delay any treatment decisions I need to make now?
2Since this study is tracking serious adverse events related to the PULSTA device over 12 months, what kinds of procedural or device-related complications have been seen with transcatheter pulmonary valve replacement in general, and how does that compare to my surgical options?
3The trial is measuring hemodynamic functional improvement at 12 months — what does that actually mean for someone in my situation, and how would we know if my heart function was genuinely improving versus just stable?
4Because this is an observational study rather than a randomized trial, does that mean it's watching outcomes in people already receiving this device rather than testing something new — and if so, what would I personally gain by participating versus just receiving standard care?
5Are there other active trials or established treatments for my specific heart condition that might be worth considering alongside or instead of waiting for this observational study to open?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Procedural / device-related serious adverse events at 12 months