Melody PB1016 Surveillance Study

Medtronic

Status: Completed

Conditions: Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Treatments: Device: Melody Transcatheter Pulmonary Valve PB1016

Study type: Interventional

Funder types: Industry

Identifiers

NCT02347189

10154745DOC

Details and patient eligibility

About

Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.

Enrollment: 39 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient eligible to receive Melody TPV PB1016 per current Instructions for Use (IFU) indications at time of study enrollment
• Patient (or patient's legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements.

Exclusion criteria

• Implantation in the aortic, tricuspid, or mitral position
• Venous anatomy unable to accommodate a 22-Fr size introducer sheath
• Obstruction of the central veins
• Clinical or biological signs of infection including active endocarditis
• History of intravenous substance abuse
• Currently participating in an investigational drug or device study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Melody TPV PB1016

Other group

Treatment:

Device: Melody Transcatheter Pulmonary Valve PB1016