PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

April 8, 2026 updated by: Taewoong Medical Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • München
      • München, München, Germany, 80636
        • Deutsches Herzzentrum München
  • Italy
    • San Donato Milanese
      • Milan, San Donato Milanese, Italy, 20097
        • Policlinico San Donato
  • Netherlands
    • Utrecht
      • Utrecht, Utrecht, Netherlands, 3508
        • Utrecht University Wilhelmina
    • Wytemaweg
      • Rotterdam, Wytemaweg, Netherlands, 3015
        • Erasmus Medical Center
  • South Korea
    • Daehak-ro Jongno-gu
      • Seoul, Daehak-ro Jongno-gu, South Korea, 03080
        • Seoul National University Hospital
    • Hohyun-ro, Sosa-gu
      • Bucheon-si, Hohyun-ro, Sosa-gu, South Korea, 14754
        • Sejong General Hospital
    • Yonsei-ro, Seodaemun-gu
      • Seoul, Yonsei-ro, Seodaemun-gu, South Korea, 03722
        • Severance Hospital
  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28007
        • Gregorio Maranon Hospital
      • Madrid, Madrid, Spain, 28046
        • University Hospital La Paz
  • Turkey (Türkiye)
    • Topkapı, Zetinburnu/İstanbul
      • Istanbul, Topkapı, Zetinburnu/İstanbul, Turkey (Türkiye), 34010
        • Koc University Hospital
    • Üsküdar/İstanbul
      • Istanbul, Üsküdar/İstanbul, Turkey (Türkiye), 34668
        • Siyami Ersek Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PULSTA TPV
PULSTA Transcatheter Pulmonary Valve (TPV) System
Device: PULSTA TPV System
PULSTA transcatheter pulmonary valve replacement.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Procedural/Device related serious adverse events at 6 months
Time Frame: 6 months
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)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural / Device related serious adverse events
Time Frame: 5 years
5 years
Other adverse events
Time Frame: 5 years
5 years
Procedural Success
Time Frame: 7 days
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.
7 days
Hemodynamic Function
Time Frame: 5 years
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.
5 years
Pulmonary Regurgitant Fraction
Time Frame: 6months
Pulmonary regurgitant fraction (PRF) will be assessed via cardiac MRI at 6 months after the PULSTA TPV implantation.
6months
Severity of Pulmonary Regurgitation
Time Frame: 5 years
Severity of pulmonary regurgitation will be assessed via Doppler echocardiography.
5 years
NYHA functional classification
Time Frame: 5 years
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.
5 years
Catheter reintervention on TPV
Time Frame: 5 years
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.
5 years
Reoperation
Time Frame: 5 years
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.
5 years
Death (All cause / procedural/device-related)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taewoong Medical Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Avania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mario Carminati, PhD. MD., Policlinico San Donato
  • Principal Investigator: Jose Luis Zunzunegui, PhD. MD., Gregorio Maranon Hospital
  • Principal Investigator: Federico Gutierrez Larraya, PhD. MD., Hospital Universitario La Paz
  • Principal Investigator: Ahmet Çelebi, PhD. MD., Siyami Ersek Hospital
  • Principal Investigator: Gregor Krings, PhD. MD., Utrecht University Wilhelmina
  • Principal Investigator: Thomas Krasemann, PhD. MD., Erasmus Medical Center
  • Principal Investigator: Gi Beom Kim, PhD. MD., Seoul National University Hospital
  • Principal Investigator: Jae Young Choi, PhD. MD., Severance Hospital
  • Principal Investigator: Stanimir Georgiev, PhD. MD., Deutsches Herzzentrum München
  • Principal Investigator: Ender Odemis, PhD. MD., Koc University Hospital
  • Principal Investigator: Seong Ho Kim, PhD. MD., Sejong General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TWTPV-E1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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