Harmony TPV Post-Approval Study

Covidien

Status: Enrolling

Conditions: Tetrology of Fallot; Pulmonary Regurgitation; RVOT Anomaly; Congenital Heart Disease

Treatments: Device: Harmony TPV System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05077774

MDT20057CON003

Details and patient eligibility

About

The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
• Patient (or patient's legally authorized representative) is willing to consent to participate in the study

Exclusion criteria

• Obstruction of the central veins
• Planned concomitant branch pulmonary artery stenting at time of implant
• Subject is pregnant at time of implant procedure
• Patients with previously treated with an RV-PA conduit or previously implanted bioprosthesis
• A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
• Planned implantation of the Harmony TPV in the left heart
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• Pre-existing prosthetic heart valve or prosthetic ring in any position

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Harmony TPV System

Other group

Description:

Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System

Treatment:

Device: Harmony TPV System