Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

Completed · Not applicable

Conditions studied: Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits

In brief

The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Key facts

Study ID

NCT00740870

Run by

Medtronic Cardiovascular

People needed

171

Starts

2007-01-01

Expected to finish

2020-08-21

Last updated by the study team

2024-03-26

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, or a stented bioprosthesis with a rigid circumferential sewing ring in the RVOT that has an internal diameter greater than or equal to 18 mm and less than or equal to 22 mm when originally implanted.
• Any of the following by transthoracic echocardiography:
• For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/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 AND/OR Mean RVOT gradient greater or equal to 40 mmHg

You may not qualify if…

• Active endocarditis
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year
• Patient or 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
• Positive urine or serum pregnancy test 24 hours prior to procedure in female patients of child bearing potential
• Known intravenous drug abuse

Where it is running

• Nicklaus Children's Hospital — Miami, Florida, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Children's Hospital of NY-Presbyterian — New York, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Seattle Children's and Regional Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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