PULSTA TPV Observational Study

N/ANot Yet RecruitingNCT07747207

Taewoong Medical Co., Ltd.200 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Heart Disease

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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.

Locations (9)

Deutsches Herzzentrum München

Munich, Bavaria, Germany

Ospedale Niguarda (Milano)

Milan, Lombardy, Italy

Polish Mother's memorial hospital

Lodz, Łódź Voivodeship, Poland

Bucheon Sejong Hospital

Bucheon-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Procedural / device-related serious adverse events at 12 months

Time frame: 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

Time frame: 12 months

Secondary Outcomes

Procedural success

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.

Time frame: 24 hours

Hemodynamic function at all follow-up visits

Hemodynamic function will be assessed including: * Peak RVOT pressure gradient (by echocardiography) * Mean RVOT pressure gradient (by echocardiography)

Time frame: 5 years

Severity of pulmonary regurgitation (by echocardiography)

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

Time frame: 5 years

NYHA functional classification

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.

Time frame: 5 years

Central Contacts

Jang Mi Ko

CONTACT

+82 31 904 6187 jmko@stent.net

Hyejin Roh

CONTACT

+82 70 4649 1624 hjroh@stent.net

Data from ClinicalTrials.gov

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