Clinical trial NCT01186692: Melody® Transcatheter Pulmonary Valve Post-Approval Study
Official title: Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-08-23
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation
timeFrame: 6 months
Secondary outcomes:
measure: Procedural Success
timeFrame: 6 Months
measure: Serious Procedural Adverse Events
timeFrame: 6 Months
measure: Serious Device-related Adverse Events
timeFrame: 6 months
measure: Changes in NYHA Functional Classification
timeFrame: 6 Months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Oak Lawn
country: United States
facility: Advocate Hope Children's Hospital
state: Illinois
city: Ann Arbor
country: United States
facility: CS Mott Children's Hospital, University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center Dallas, UT Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center, University of Utah
state: Utah
Study officials:
affiliation: Children's Hospital of University of Pittsburgh Medical Center
name: Jaqueline Kreutzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armstrong AK, Berger F, Jones TK, Moore JW, Benson LN, Cheatham JP, Turner DR, Rhodes JF, Vincent JA, Zellers T, Lung TH, Eicken A, McElhinney DB. Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials. Catheter Cardiovasc Interv. 2019 Oct 1;94(4):607-617. doi: 10.1002/ccd.28454. Epub 2019 Aug 16.
citation: Armstrong AK, Balzer DT, Cabalka AK, Gray RG, Javois AJ, Moore JW, Rome JJ, Turner DR, Zellers TM, Kreutzer J. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014 Nov;7(11):1254-62. doi: 10.1016/j.jcin.2014.08.002. Epub 2014 Nov 17.
citation: McElhinney DB, Benson LN, Eicken A, Kreutzer J, Padera RF, Zahn EM. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. 2013 Jun;6(3):292-300. doi: 10.1161/CIRCINTERVENTIONS.112.000087. Epub 2013 Jun 4.