NCT07747207

Brief Summary

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

Trial Health

70
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
85mo left

Started Oct 2026

Longer than P75 for all trials

Geographic Reach
6 countries

9 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2033

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

1.8 years

First QC Date

July 30, 2026

Last Update Submit

August 5, 2026

Conditions

Heart Disease

Keywords

Pulmonary Valve RegurgitationPulmonary Valve StenosisTetralogy of Fallot

Outcome Measures

Primary Outcomes (2)

  • Procedural / device-related serious adverse events at 12 months

    12 months

  • Hemodynamic functional improvement at 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

    12 months

Secondary Outcomes (9)

  • Procedural success

    24 hours

  • Hemodynamic function at all follow-up visits

    5 years

  • Severity of pulmonary regurgitation (by echocardiography)

    5 years

  • NYHA functional classification

    5 years

  • Freedom from death

    5 years

  • +4 more secondary outcomes

Study Arms (1)

PULSTA TPV Recipients

Single-arm cohort consisting of all eligible patients undergoing percutaneous pulmonary valve implantation(PPVI) with the PULSTA TPV as part of routine clinical care

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with right ventricular outflow tract (RVOT) dysfunction who are considered eligible for percutaneous pulmonary valve implantation (PPVI) with the PULSTA TPV according to the approved indication and routine clinical practice at participating centers.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

Location

Ospedale Niguarda (Milano)

Milan, Lombardy, 20162, Italy

Location

Polish Mother's memorial hospital

Lodz, Łódź Voivodeship, 93-338, Poland

Location

Bucheon Sejong Hospital

Bucheon-si, Gyeonggi-do, 14754, South Korea

Location

Seoul National University Hospital (Seoul)

Seoul, 3080, South Korea

Location

Severance Hospital (Seoul)

Seoul, 3722, South Korea

Location

La Paz Hospital (Madrid)

Madrid, Madrid, 28046, Spain

Location

Koc University Hospital (Istanbul)

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

Siyami Ersek Hospital (Istanbul)

Istanbul, Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart DiseasesPulmonary Valve InsufficiencyPulmonary Valve StenosisTetralogy of Fallot

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesHeart Valve DiseasesVentricular Outflow ObstructionHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mario Carminati

    Niguarda Hospital

    STUDY CHAIR

Central Study Contacts

Jang Mi Ko

CONTACT

+82 31 904 6187jmko@stent.net

Hyejin Roh

CONTACT

+82 70 4649 1624hjroh@stent.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 5, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

October 1, 2033

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)IT(1)TU(2)PL(1)DE(1)KR(3)