Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

Taewoong Medical

Status

Completed

Conditions

Pulmonary Valve; Insufficiency, Congenital

Pulmonary Valve Stenosis

Congenital Heart Defect

Treatments

Device: Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement

Study type

Interventional

Funder types

Industry

Identifiers

NCT03110861

TPV-101

Details and patient eligibility

About

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

Full description

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.

Enrollment

15 patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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.