PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Taewoong Medical

Status: Active, not recruiting

Conditions: Tetralogy of Fallot; Pulmonary Valve Stenosis; Heart Diseases; Pulmonary Valve Regurgitation

Treatments: Device: PULSTA TPV System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03983512

TWTPV-E1001

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.

Full description

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. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation.

Enrollment: 58 estimated 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 or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient >35mmHg by echocardiography
• Main pulmonary artery trunk of ≥16 mm and ≤30 mm
• Patients willing to provide written informed consent and comply with follow-up evaluations.

Exclusion criteria

• Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation
• Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves
• Obstruction of the central veins to be approached for the TPV implantation
• Coronary artery compression confirmed by angiography
• A known severe allergy to Nickel
• A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease
• Suspected active infectious disease (e.g. endocarditis, meningitis)
• Life expectancy of less than 6 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

PULSTA TPV

Experimental group

Description:

PULSTA Transcatheter Pulmonary Valve (TPV) System

Treatment:

Device: PULSTA TPV System