Melody® Transcatheter Pulmonary Valve Post-Approval Study

Covidien

Status: Completed

Conditions: Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit

Treatments: Device: Melody® Transcatheter Pulmonary Valve

Study type: Interventional

Funder types: Industry

Identifiers

NCT01186692

D03909

Details and patient eligibility

About

The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.

Enrollment: 131 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
• Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)

Exclusion criteria

• Implantation in the aortic 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
• Unwilling or unable to provide written informed consent or comply with the follow-up requirements

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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131 participants in 1 patient group

Melody TPV Implant

Experimental group

Description:

Melody® Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.

Treatment:

Device: Melody® Transcatheter Pulmonary Valve