Active — Not RecruitingNot Applicable

PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Germany, Italy, Netherlands58 participantsStarted 2019-10-07

Plain-language summary

The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.

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: * Body weight greater than or equal to 30 kilograms * Pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient \>35mmHg by echocardiography * Main pulmonary artery trunk of ≥16 mm and ≤30 mm * Patients willing to provide written informed consent and comply with follow-up evaluations. Exclusion Criteria: * Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation * Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves * Obstruction of the central veins to be approached for the TPV implantation * Coronary artery compression confirmed by angiography * A known severe allergy to Nickel * A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease * Suspected active infectious disease (e.g. endocarditis, meningitis) * Life expectancy of less than 6 months

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Procedural/Device related serious adverse events at 6 months

Timeframe: 6 months

Hemodynamic functional improvement at 6 months

Timeframe: 6 months

Trial details

NCT IDNCT03983512

SponsorTaewoong Medical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-21

View on ClinicalTrials.gov More Heart Diseases trials

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.