Congenital Heart DefectsNCT02555319
A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)
A study testing Transcatheter Pulmonary Valve (TPV) in people with Congenital Heart Defects and Cardiovascular Abnormalities, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Congenital Heart Defects, Cardiovascular Abnormalities, Pulmonary Valve Insufficiency
- What is being tested?
- Transcatheter Pulmonary Valve (TPV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Aug 2015to 25 Oct 2021
- 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
- Age greater than or equal to 10 years of age
- 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 ≥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
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Haehak-ro Jongno-gu, 03080
About this study
Official title: A Feasibility Study to Evaluate the Safety and Short-term 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 short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.
Read the detailed description
Diverse congenital heart diseases involving the pulmonary artery, such as Tetralogy of Fallot (TOF) with or without pulmonary atresia, or transposition of the great arteries with pulmonary stenosis, require implantation of an artificial conduit between the right ventricle and the pulmonary artery(PA). Because these conduits finally degenerate and result in pulmonary regurgitation and/or stenosis and progressive right ventricle (RV) dilation and eventual failure, patients need repetitive surgery for conduit revision. Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to surgery in patients with dysfunctional right ventricular outflow tract (RVOT). TPV is a large-diameter (up to 28 mm) self-expandable stent with a relatively low profile from a nitinol wire backbone with valve leaflets made from porcine pericardial tissue. 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 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 Defects, Cardiovascular Abnormalities, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Being tested
- Transcatheter Pulmonary Valve (TPV)
- Keywords
- Pulmonary Valve, Transcatheter Pulmonary Valve, Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital, Cardiovascular Abnormalities, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Pulmonary Valve (TPV)Device
Transcatheter Pulmonary Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Pulmonary Valve | Experimental | Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea) Receives: Device: Transcatheter Pulmonary Valve (TPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Procedural success is defined as the TPV implant within desired position, 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: 5day
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 month
Procedural / Device related serious adverse events at 6month
Measured: 6 month
Secondary outcomes (10)
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 year
Severity of pulmonary regurgitation
Measured: 5year
Pulmonary regurgitant fraction
Measured: 5year
New York Heart Association (NYHA) functional classification
Measured: 5 year
Stent fracture
Measured: 5 year
Catheter reintervention on TPV
Measured: 5 year
Reoperation
Measured: 5 year
Procedural / Device related serious adverse events
Measured: 5 year
Death (all cause / procedural / device-related)
Measured: 5 year
Other adverse events
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study start26 Aug 2015
- Primary completion14 Apr 2017
- Study completion25 Oct 2021
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 Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gi Beom Kim, PhD. MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555319
- Sponsor's protocol ID
- TPV-001
- Status last verified
- Jan 2023
- First submitted
- 9 Sep 2015
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim GB, Song MK, Bae EJ, Park EA, Lee W, Lim HG, Kim YJ. Successful Feasibility Human Trial of a New Self-Expandable Percutaneous Pulmonary Valve (Pulsta Valve) Implantation Using Knitted Nitinol Wire Backbone and Trileaflet alpha-Gal-Free Porcine Pericardial Valve in the Native Right Ventricular Outflow Tract. Circ Cardiovasc Interv. 2018 Jun;11(6):e006494. doi: 10.1161/CIRCINTERVENTIONS.118.006494.
PubMed 29871940
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Implantation of Transcatheter Pulmonary Valve (TPV) for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease
- ClinicalTrials.gov ID
- NCT02555319
- Acronym / sponsor ID
- TPV-001
- Conditions
- Congenital Heart Defects, Cardiovascular Abnormalities, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Keywords
- Pulmonary Valve, Transcatheter Pulmonary Valve, Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Aug 2015 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 21 Sep 2015 (estimated)
- 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 short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.
Detailed description
Diverse congenital heart diseases involving the pulmonary artery, such as Tetralogy of Fallot (TOF) with or without pulmonary atresia, or transposition of the great arteries with pulmonary stenosis, require implantation of an artificial conduit between the right ventricle and the pulmonary artery(PA). Because these conduits finally degenerate and result in pulmonary regurgitation and/or stenosis and progressive right ventricle (RV) dilation and eventual failure, patients need repetitive surgery for conduit revision. Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to surgery in patients with dysfunctional right ventricular outflow tract (RVOT). TPV is a large-diameter (up to 28 mm) self-expandable stent with a relatively low profile from a nitinol wire backbone with valve leaflets made from porcine pericardial tissue. 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 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 |
|---|---|---|
| Transcatheter Pulmonary Valve | Experimental | Device: Transcatheter Pulmonary Valve (TPV)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 (5 listed)
- Age greater than or equal to 10 years of age
- 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 ≥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 |
|---|---|---|
| Transcatheter Pulmonary Valve (TPV)Transcatheter Pulmonary Valve Replacement | Device | Transcatheter Pulmonary Valve |
Primary outcome
Procedural success
Time frame: 5day
Procedural success is defined as the TPV implant within desired position, 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.
Hemodynamic functional improvement at 6month
Time frame: 6 month
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 month
10 secondary outcomes
Hemodynamic function
Time frame: 5 year
Severity of pulmonary regurgitation
Time frame: 5year
Pulmonary regurgitant fraction
Time frame: 5year
New York Heart Association (NYHA) functional classification
Time frame: 5 year
Stent fracture
Time frame: 5 year
Catheter reintervention on TPV
Time frame: 5 year
Reoperation
Time frame: 5 year
Procedural / Device related serious adverse events
Time frame: 5 year
Death (all cause / procedural / device-related)
Time frame: 5 year
Other adverse events
Time frame: 5 year
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 6 Feb 2023.
- Derived from this study: PubMed 29871940Kim GB, Song MK, Bae EJ, Park EA, Lee W, Lim HG, Kim YJ. Successful Feasibility Human Trial of a New Self-Expandable Percutaneous Pulmonary Valve (Pulsta Valve) Implantation Using Knitted Nitinol Wire Backbone and Trileaflet alpha-Gal-Free Porcine Pericardial Valve in the Native Right Ventricular Outflow Tract. Circ Cardiovasc Interv. 2018 Jun;11(6):e006494. doi: 10.1161/CIRCINTERVENTIONS.118.006494.
- 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 principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Pulmonary Valve (TPV) in people with Congenital Heart Defects and Cardiovascular Abnormalities, run by Seoul National University Hospital at 1 site 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 5 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 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Procedural success (time frame: 5day). The study lists 3 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 NCT02555319, 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 6 Feb 2023.