Clinical trial NCT02347189: Melody PB1016 Surveillance Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year
timeFrame: 1 Year
measure: Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years
timeFrame: 2 Years
measure: Number of Subjects With Serious Procedure-related and Device-related Adverse Events
timeFrame: 1 Year, 2 Years
measure: Number of Subjects With Procedural Success
timeFrame: At Time Of Procedure
measure: Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Columbus
country: United States
facility: Nationwide Childrens Hospital
state: Ohio
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Childrens and Regional Hospital
state: Washington
city: Linz
country: Austria
facility: Landes-Kinderklinik
city: Edmonton
country: Canada
facility: Stollery Childrens Hospital
state: Alberta
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
References:
citation: Morray BH, Jones TK, Coe JY, Gitter R, Martinez JZ, Turner DR, Gray RG, Lung TH, Berman DP, Levi DS. Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits. Catheter Cardiovasc Interv. 2019 Feb 15;93(3):474-480. doi: 10.1002/ccd.27974. Epub 2018 Nov 12.