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

Covidien

Status: Completed

Conditions: Congenital Heart Defects; Dysfunctional Right Ventricular Outflow Tract Conduits

Treatments: Device: Transcatheter Pulmonary Valve replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT00740870

G050186

Details and patient eligibility

About

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.

Full description

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 is to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Enrollment: 171 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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, 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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171 participants in 1 patient group

Melody TPV Implant

Experimental group

Description:

Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.

Treatment:

Device: Transcatheter Pulmonary Valve replacement