Heart DiseasesNCT03983512
PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
A study testing PULSTA TPV System in people with Heart Diseases and Pulmonary Valve Regurgitation, run by Taewoong Medical Co., Ltd. at 11 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis
- What is being tested?
- PULSTA TPV System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 7 Oct 2019to Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
South Korea3 sites
Sejong General Hospital
Bucheon-si, Hohyun-ro, Sosa-gu, 14754
Seoul National University Hospital
Seoul, Daehak-ro Jongno-gu, 03080
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu, 03722
Netherlands2 sites
Erasmus Medical Center
Rotterdam, Wytemaweg, 3015
Utrecht University Wilhelmina
Utrecht, Utrecht, 3508
Spain2 sites
Gregorio Marañon hospital
Madrid, Madrid, 28007
University Hospital La Paz
Madrid, Madrid, 28046
Turkey (Türkiye)2 sites
Koc University Hospital
Istanbul, Topkapı, Zetinburnu/İstanbul, 34010
Siyami Ersek Hospital
Istanbul, Üsküdar/İstanbul, 34668
About this study
Official title: The PULSTA Transcatheter Pulmonary Valve (TPV) Pre-Approval Study
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.
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. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation.
- Conditions
- Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Being tested
- PULSTA TPV System
- 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.
PULSTA TPV SystemDevice
PULSTA transcatheter pulmonary valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| PULSTA TPV | Experimental | PULSTA Transcatheter Pulmonary Valve (TPV) System Receives: Device: PULSTA TPV System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural/Device related serious adverse events at 6 months
Measured: 6 months
Hemodynamic functional improvement at 6 months
Hemodynamic functional improvement is a composite of mean RVOT gradient ≤30 mmHg by continuous wave Doppler and a pulmonary regurgitant fraction <20% by cardiac magnetic resonance (MR)
Measured: 6 months
Secondary outcomes (10)
Procedural Success
Procedural success is defined as the TPV implant within desired position, Right ventricle-Pulmonary artery (RV-PA) peak systolic pressure gradient <35mmHg by catheter, less mild pulmonary regurgitation by angiography, and freedom from explantation of the TPV at 24 hours post-implant.
Measured: 7 days
Hemodynamic Function
Hemodynamic function will be assessed including peak RVOT pressure gradient, mean RVOT pressure gradient, right ventricle (RV) end-diastolic volume index by echocardiography or cardiac MR.
Measured: 5 years
Pulmonary Regurgitant Fraction
Pulmonary regurgitant fraction (PRF) will be assessed via cardiac MRI at 6 months after the PULSTA TPV implantation.
Measured: 6months
Severity of Pulmonary Regurgitation
Severity of pulmonary regurgitation will be assessed via Doppler echocardiography.
Measured: 5 years
NYHA functional classification
Clinical outcome will be assessed as per the New York Heart Association (NYHA) functional classification t all follow-up visits and will be compared to baseline values.
Measured: 5 years
Catheter reintervention on TPV
Catheter re-intervention on PULSTA TPV is defined as any interventional catheter procedure (e.g. balloon angioplasty) that alters or adjusts, or replaces a previously implanted PULSTA TPV during a 5-year follow-up period, and the frequency will be evaluated.
Measured: 5 years
Reoperation
Reoperation is defined as open surgery that alters or adjusts, or replaces a previously implanted PULSTA TPV during a 5-year follow-up period, and the frequency will be evaluated.
Measured: 5 years
Procedural / Device related serious adverse events
Measured: 5 years
Death (All cause / procedural/device-related)
Measured: 5 years
Other 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 posted12 Jun 2019
- Study start7 Oct 2019
- Primary completion21 Sep 2022
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taewoong Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Mario Carminati, PhD. MD., Study chair, Policlinico San DonatoStanimir Georgiev, PhD. MD., Principal investigator, Deutsches Herzzentrum MunchenJose Luis Zunzunegui, PhD. MD., Principal investigator, Gregorio Marañon hospitalFederico Gutierrez Larraya, PhD. MD., Principal investigator, Hospital Universitario La PazEnder Odemis, PhD. MD., Principal investigator, Koc University HospitalAhmet Çelebi, PhD. MD., Principal investigator, Siyami Ersek HospitalGregor Krings, PhD. MD., Principal investigator, Utrecht University WilhelminaThomas Krasemann, PhD. MD., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983512
- Sponsor's protocol ID
- TWTPV-E1001
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SY, Kim GB, Carminati M, Giugno L, Celebi A, Yucel IK, Eicken A, Ewert P, Georgiev S, Choi JY, Kim CS, Gutierrez-Larraya F, Balbacid Domingo E, Odemis E, Kizilkaya MH, Luis Zunzunegui J, Ballesteros Tejerizo F, Kim SH, Jang SI, Krasemann T, Krings G. Prospective Midterm Outcomes of the PULSTA Self-Expandable Transcatheter Pulmonary Valve: The PULSTA CE Approval Study. Circ Cardiovasc Interv. 2026 Jun 18:e016616. doi: 10.1161/CIRCINTERVENTIONS.126.016616. Online ahead of print.
PubMed 42312408
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PULSTA Transcatheter Pulmonary Valve (TPV) Pre-Approval Study
- ClinicalTrials.gov ID
- NCT03983512
- Acronym / sponsor ID
- TWTPV-E1001
- Conditions
- Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Taewoong Medical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jun 2019 (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 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.
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. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PULSTA TPV | Experimental | Device: PULSTA TPV SystemPULSTA Transcatheter Pulmonary Valve (TPV) System |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PULSTA TPV SystemPULSTA transcatheter pulmonary valve replacement. | Device | PULSTA TPV |
Primary outcome
Procedural/Device related serious adverse events at 6 months
Time frame: 6 months
Hemodynamic functional improvement at 6 months
Time frame: 6 months
Hemodynamic functional improvement is a composite of mean RVOT gradient ≤30 mmHg by continuous wave Doppler and a pulmonary regurgitant fraction <20% by cardiac magnetic resonance (MR)
10 secondary outcomes
Procedural Success
Time frame: 7 days
Hemodynamic Function
Time frame: 5 years
Pulmonary Regurgitant Fraction
Time frame: 6months
Severity of Pulmonary Regurgitation
Time frame: 5 years
NYHA functional classification
Time frame: 5 years
Catheter reintervention on TPV
Time frame: 5 years
Reoperation
Time frame: 5 years
Procedural / Device related serious adverse events
Time frame: 5 years
Death (All cause / procedural/device-related)
Time frame: 5 years
Other 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 13 Apr 2026.
- Derived from this study: PubMed 42312408Lee SY, Kim GB, Carminati M, Giugno L, Celebi A, Yucel IK, Eicken A, Ewert P, Georgiev S, Choi JY, Kim CS, Gutierrez-Larraya F, Balbacid Domingo E, Odemis E, Kizilkaya MH, Luis Zunzunegui J, Ballesteros Tejerizo F, Kim SH, Jang SI, Krasemann T, Krings G. Prospective Midterm Outcomes of the PULSTA Self-Expandable Transcatheter Pulmonary Valve: The PULSTA CE Approval Study. Circ Cardiovasc Interv. 2026 Jun 18:e016616. doi: 10.1161/CIRCINTERVENTIONS.126.016616. Online ahead of print.
- 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. This study is not recruiting at the moment.
Mario Carminati, PhD. MD. study chair
Policlinico San Donato
Stanimir Georgiev, PhD. MD. principal investigator
Deutsches Herzzentrum Munchen
Jose Luis Zunzunegui, PhD. MD. principal investigator
Gregorio Marañon hospital
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PULSTA TPV System in people with Heart Diseases and Pulmonary Valve Regurgitation, run by Taewoong Medical Co., Ltd. at 11 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea, Netherlands, Spain, Turkey (Türkiye), Germany 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural/Device related serious adverse events at 6 months (time frame: 6 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?
On the ClinicalTrials.gov record for NCT03983512, which also lists 1 linked publication.
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 13 Apr 2026.