Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study

Medtronic

Status

Completed

Conditions

Heart Valve Diseases

Treatments

Device: Melody Transcatheter Pulmonary Valve

Study type

Interventional

Funder types

Industry

Identifiers

NCT00688571

BRC-CS-PMSS

Details and patient eligibility

About

This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market environment over a period of five years after transcatheter implantation in patients with dysfunctional RVOT conduits. In addition, the quality of life of implanted subjects will be assessed over five years.

Enrollment

63 patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Prospective subjects have complex congenital heart defects that have been palliated with RVOT conduits that have become dysfunctional and have a clinical indication for invasive intervention. Prospective subjects must meet all of following inclusion and exclusion criteria:

Inclusion Criteria:

Age greater than or equal to 5 years of age
Weight greater than or equal to 30 kilograms
Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
Any of the following by transthoracic echocardiography

For patients in NYHA Classification II, III, or IV:

Moderate (3+) or severe (4+) pulmonary regurgitation, or
Mean RVOT gradient greater than or equal to 35 mmHg.

For patients in NYHA Classification I:

Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction, or
Mean RVOT gradient greater than or equal to 40 mmHg.

Exclusion Criteria:

Active endocarditis
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
Patient or - for patients who cannot legally give consent themselves- the guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
Known intravenous drug abuse