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

Melody TPV Post-Market Surveillance Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00688571

Enrollment

Registered

2008-06-03

Start date

2007-10-31

Completion date

2014-12-31

Last updated

2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Diseases

Keywords

Pulmonary Valve, Congenital Heart Disease

Brief summary

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.

Interventions

DEVICEMelody Transcatheter Pulmonary Valve

Transcatheter valve implantation into a RV-PA conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs intervention

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death	August 2014

Secondary

Measure	Time frame
Procedural success	August 2014
Incidence of device and procedure related adverse events	August 2014
Hemodynamic Performance	August 2014

Countries

Canada, Denmark, Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026