Heart DiseaseNCT07747207
PULSTA TPV Observational Study
An observational study of Heart Disease, run by Taewoong Medical Co., Ltd. at 9 sites in 6 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Heart Disease
- How many people
- 200 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Oct 2026to Oct 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with right ventricular outflow tract (RVOT) dysfunction who are considered eligible for percutaneous pulmonary valve implantation (PPVI) with the PULSTA TPV according to the approved indication and routine clinical practice at participating centers.
Who may be able to join
- 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.
Who cannot join
- Patients who have not signed informed consent
- Patients who are contraindicated for the implantation per the device's Instructions for Use.
Trial locations and contacts
9 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 6 countries
South Korea3 sites
Bucheon Sejong Hospital
Bucheon-si, Gyeonggi-do, 14754
Seoul National University Hospital (Seoul)
Seoul, 3080
Severance Hospital (Seoul)
Seoul, 3722
Turkey (Türkiye)2 sites
Koc University Hospital (Istanbul)
Istanbul, Istanbul, 34010
Siyami Ersek Hospital (Istanbul)
Istanbul, Istanbul, 34668
About this study
Official title: An Observational Study on the Clinical Outcomes and Long-term Follow-up of the PULSTATM Transcatheter Pulmonary Valve (TPV)
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
Read the 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.
- Conditions
- Heart Disease
- Keywords
- Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Medical subject headings
- Heart Diseases, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PULSTA TPV Recipients | Single-arm cohort consisting of all eligible patients undergoing percutaneous pulmonary valve implantation(PPVI) with the PULSTA TPV as part of routine clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural / device-related serious adverse events at 12 months
Measured: 12 months
Hemodynamic functional improvement at 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
Measured: 12 months
Secondary outcomes (9)
Procedural success
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.
Measured: 24 hours
Hemodynamic function at all follow-up visits
Hemodynamic function will be assessed including:
- Peak RVOT pressure gradient (by echocardiography)
- Mean RVOT pressure gradient (by echocardiography)
Measured: 5 years
Severity of pulmonary regurgitation (by echocardiography)
Severity of pulmonary regurgitation will be measured by Doppler echocardiography and classified into none, trace/trivial, mild, moderate, and severe.
Measured: 5 years
NYHA functional classification
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.
Measured: 5 years
Freedom from death
Frequency of all cause / cardiac / non-cardiac / procedural-related / device-related deaths during the 5-year follow-up period
Measured: 5 years
Freedom from re-operation
Reoperation is defined as open surgery that alters or adjusts, or replaces a previously implanted PULSTA
Measured: 5 years
Freedom from catheter re-intervention
Any interventional catheter procedure (e.g. balloon angioplasty) that alters or adjusts, or replaces a previously implanted PULSTA TPV
Measured: 5 years
Freedom from TPV dysfunction
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
Measured: 5 years
Incidence of procedural- and device-related adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Taewoong Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Mario Carminati, Study chair, Niguarda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747207
- Sponsor's protocol ID
- TWTPV-ER1001
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Clinical Outcomes and Long-term Follow-up of the PULSTATM Transcatheter Pulmonary Valve (TPV)
- ClinicalTrials.gov ID
- NCT07747207
- Acronym / sponsor ID
- TWTPV-ER1001
- Conditions
- Heart Disease
- Keywords
- Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taewoong Medical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Oct 2033 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PULSTA TPV Recipients | – | –Single-arm cohort consisting of all eligible patients undergoing percutaneous pulmonary valve implantation(PPVI) with the PULSTA TPV as part of routine clinical care |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with right ventricular outflow tract (RVOT) dysfunction who are considered eligible for percutaneous pulmonary valve implantation (PPVI) with the PULSTA TPV according to the approved indication and routine clinical practice at participating centers.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who have not signed informed consent
- Patients who are contraindicated for the implantation per the device's Instructions for Use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procedural / device-related serious adverse events at 12 months
Time frame: 12 months
Hemodynamic functional improvement at 12 months
Time frame: 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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Carminati study chair
Niguarda Hospital
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease, run by Taewoong Medical Co., Ltd. at 9 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea, Turkey (Türkiye), Germany, Italy, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jang Mi Ko (+82 31 904 6187 ext. 637, jmko@stent.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural / device-related serious adverse events at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.