Congenital Heart DefectNCT03110861
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
A study testing Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement in people with Congenital Heart Defect and Pulmonary Valve; Insufficiency, Congenital, run by Taewoong Medical Co., Ltd. at 5 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
- What is being tested?
- Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 22 Mar 2017to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 pulmonary regurgitation (PR) (≥3+) or RVOT conduit obstruction with mean gradient >35mmHg by echocardiography
- pulmonary artery annulus or in situ conduit size of ≥16 and ≤26mm
- Patient willing to provide written informed consent and comply with follow-up requirements
Who cannot join
- Pre-existing mechanical heart valve in any position
- Obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart)
- Coronary artery compression
- A known hypersensitivity to Aspirin or Heparin
- Immunosuppressive disease
- Active infectious disease (e.g. endocarditis, meningitis)
- Estimated survival less than 6 months
- Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Sejong General Hospital
Bucheon-si, Hohyun-ro, Sosa-gu, 14754
Seoul National University Hospital
Seoul, Haehak-ro Jongno-gu, 03080
Samsung Medical Center
Seoul, Ilwon-ro, Gangnam-gu, 06351
Asan Medical Center
Seoul, Olympic-ro, Songpa-gu, 05505
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu, 03722
About this study
Official title: A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Implantation of 'Transcatheter Pulmonary Valve (TPV)' for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
Read the detailed description
The TPV is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional right ventricular ourflow tract (RVOT) requiring treatment for severe pulmonary regurgitation and/or RVOT conduit obstruction. Consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post TPV implantation.
- Conditions
- Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
- Being tested
- Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
- Medical subject headings
- Heart Defects, Congenital, Pulmonary Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsta® Transcatheter Pulmonary Valve (TPV) ReplacementDevice
Pulsta® Transcatheter Pulmonary Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Pulsta® Transcatheter Pulmonary Valve | Experimental | Pulsta® Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea) Receives: Device: Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic functional improvement at 6month
Hemodynamic functional improvement is defined as mean RVOT gradient ≤30 mmHg by continuous wave doppler, and a pulmonary regurgitant fraction <20% by cardiac magnetic resonance (MR).
Measured: 6 months
Procedural / Device related serious adverse events at 6month
Measured: 6 months
Secondary outcomes (11)
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: 5 days
Hemodynamic function
Hemodynamic function will be measured including peak RVOT pressure gradient, mean RVOT pressure gradient, RV-PA pressure gradient, RV pressure, cardiac output, cardiac index, RV end-diastolic volume by echocardiography, cardiac MR, or catheterization.
Measured: 5 years
Severity of pulmonary regurgitation
Measured: 5 years
New York Heart Association (NYHA) functional classification
Measured: 5 years
Stent fracture
Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy).
Measured: 5 years
Catheter reintervention on TPV
Measured: 5 years
Reoperation
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
Pulmonary regurgitant fraction
Pulmonary regurgitant fraction will be measured by cardiac MRI.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start22 Mar 2017
- Primary completion6 Nov 2019
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taewoong Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gi Beom Kim, phD. MD., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110861
- Sponsor's protocol ID
- TPV-101
- Status last verified
- Sep 2025
- First submitted
- 7 Apr 2017
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Implantation of 'Transcatheter Pulmonary Valve (TPV)' for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease
- ClinicalTrials.gov ID
- NCT03110861
- Acronym / sponsor ID
- TPV-101
- Conditions
- Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Taewoong Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 12 Apr 2017 (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 this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
Detailed description
The TPV is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional right ventricular ourflow tract (RVOT) requiring treatment for severe pulmonary regurgitation and/or RVOT conduit obstruction. Consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post 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® Transcatheter Pulmonary Valve | Experimental | Device: Pulsta® Transcatheter Pulmonary Valve (TPV) ReplacementPulsta® Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea) |
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 pulmonary regurgitation (PR) (≥3+) or RVOT conduit obstruction with mean gradient >35mmHg by echocardiography
- pulmonary artery annulus or in situ conduit size of ≥16 and ≤26mm
- Patient willing to provide written informed consent and comply with follow-up requirements
Key exclusion criteria (8 listed)
- Pre-existing mechanical heart valve in any position
- Obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart)
- Coronary artery compression
- A known hypersensitivity to Aspirin or Heparin
- Immunosuppressive disease
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® Transcatheter Pulmonary Valve (TPV) ReplacementPulsta® Transcatheter Pulmonary Valve Replacement | Device | Pulsta® Transcatheter Pulmonary Valve |
Primary outcome
Hemodynamic functional improvement at 6month
Time frame: 6 months
Hemodynamic functional improvement is defined as mean RVOT gradient ≤30 mmHg by continuous wave doppler, and a pulmonary regurgitant fraction <20% by cardiac magnetic resonance (MR).
Procedural / Device related serious adverse events at 6month
Time frame: 6 months
11 secondary outcomes
Procedural success
Time frame: 5 days
Hemodynamic function
Time frame: 5 years
Severity of pulmonary regurgitation
Time frame: 5 years
New York Heart Association (NYHA) functional classification
Time frame: 5 years
Stent fracture
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
Pulmonary regurgitant fraction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- 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.
Gi Beom Kim, phD. MD. study chair
Seoul National University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement in people with Congenital Heart Defect and Pulmonary Valve; Insufficiency, Congenital, run by Taewoong Medical Co., Ltd. at 5 sites in South Korea.
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: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hemodynamic functional improvement at 6month (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?
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 4 Sep 2025.