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NCT Number: NCT07747207

PULSTA TPV Observational Study

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

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Key information

Conditions

Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Pulmonary Valve Insufficiency Pulmonary Valve Stenosis Tetralogy of Fallot Ventricular Outflow Obstruction

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum München, Munich, Bavaria, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients who have not signed informed consent
  • Patients who are contraindicated for the implantation per the device's Instructions for Use.

Treatment and study plan

Primary outcomes

  1. Procedural / device-related serious adverse events at 12 months

    Time frame: 12 months

  2. 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

Secondary outcomes

  1. Procedural success

    Time frame: 24 hours

    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.

  2. Hemodynamic function at all follow-up visits

    Time frame: 5 years

    Hemodynamic function will be assessed including:

    • Peak RVOT pressure gradient (by echocardiography)
    • Mean RVOT pressure gradient (by echocardiography)

  3. Severity of pulmonary regurgitation (by echocardiography)

    Time frame: 5 years

    Severity of pulmonary regurgitation will be measured by Doppler echocardiography and classified into none, trace/trivial, mild, moderate, and severe.

  4. NYHA functional classification

    Time frame: 5 years

    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.

  5. Freedom from death

    Time frame: 5 years

    Frequency of all cause / cardiac / non-cardiac / procedural-related / device-related deaths during the 5-year follow-up period

  6. Freedom from re-operation

    Time frame: 5 years

    Reoperation is defined as open surgery that alters or adjusts, or replaces a previously implanted PULSTA

  7. Freedom from catheter re-intervention

    Time frame: 5 years

    Any interventional catheter procedure (e.g. balloon angioplasty) that alters or adjusts, or replaces a previously implanted PULSTA TPV

  8. Freedom from TPV dysfunction

    Time frame: 5 years

    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

  9. Incidence of procedural- and device-related adverse events

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Hyejin Roh

CONTACT

[email protected]

+82 70 4649 1624 ext. 628

Jang Mi Ko

CONTACT

[email protected]

+82 31 904 6187 ext. 637

Sponsors and collaborators

Lead sponsor

Taewoong Medical Co., Ltd.

Industry

Collaborators

  • Avania

Registry information

Official study title

An Observational Study on the Clinical Outcomes and Long-term Follow-up of the PULSTATM Transcatheter Pulmonary Valve (TPV)

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Aug 5, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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