This trial is active, not recruiting.

Condition dysfunctional rvot conduits in patients with congenital heart defects
Treatment melody transcatheter pulmonary valve pb1016
Phase phase 4
Sponsor Medtronic Heart Valves
Start date November 2014
End date November 2016
Trial size 30 participants
Trial identifier NCT02347189, 10154745DOC


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
melody transcatheter pulmonary valve pb1016

Primary Outcomes

Acceptable TPV Hemodynamic Function
time frame: 6 Months

Secondary Outcomes

Acceptable Hemodynamic Function
time frame: 1 Year
Acceptable Hemodynamic Function
time frame: 2 Years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Melody(TM) Transcatheter Pulmonary Valve PB1016 Surveillance Study Implantation of the Medtronic Melody Transcatheter Pulmonary Valve PB1016 Using the Ensemble(TM) Transcatheter Delivery System in Patients With Dysfunctional RVOT Conduits
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.