Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

Taewoong Medical Co., Ltd.15 enrolled

Overview

The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.

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 right ventricular ourflow tract (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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Heart Defect Pulmonary Valve; Insufficiency, Congenital Pulmonary Valve Stenosis

Interventions

Pulsta® Transcatheter Pulmonary Valve (TPV) ReplacementDEVICE

Pulsta® Transcatheter Pulmonary Valve Replacement

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 of ≥16 and ≤26mm * Patient willing to provide written informed consent and comply with follow-up requirements Exclusion Criteria: * 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.

Locations (5)

Seoul National University Hospital

Seoul, Haehak-ro Jongno-gu, South Korea

Sejong General Hospital

Bucheon-si, Hohyun-ro, Sosa-gu, South Korea

Samsung Medical Center

Seoul, Ilwon-ro, Gangnam-gu, South Korea

Asan Medical Center

Seoul, Olympic-ro, Songpa-gu, South Korea

Outcomes

Primary Outcomes

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).

Time frame: 6 months

Procedural / Device related serious adverse events at 6month

Time frame: 6 months

Secondary Outcomes

Procedural success

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.

Time frame: 5 days

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.

Time frame: 5 years

Severity of pulmonary regurgitation

Time frame: 5 years

New York Heart Association (NYHA) functional classification

Time frame: 5 years

Stent fracture

Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy).

Time frame: 5 years

Catheter reintervention on TPV

Time frame: 5 years

Data from ClinicalTrials.gov

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