Clinical trial NCT00740870: Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
Official title: Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defects
Dysfunctional Right Ventricular Outflow Tract Conduits
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2008-08-25
Enrollment: 171
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Detailed description: The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives is to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 5 years of age
* Weight greater than or equal to 30 kilograms
* Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, or a stented bioprosthesis with a rigid circumferential sewing ring in the RVOT that has an internal diameter greater than or equal to 18 mm and less than or equal to 22 mm when originally implanted.
* Any of the following by transthoracic echocardiography:
* For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR Mean RVOT gradient greater than or equal to 35 mmHg
* For patients in NYHA Classification I:Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction AND/OR Mean RVOT gradient greater or equal to 40 mmHg

Exclusion Criteria:

* Active endocarditis
* Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year
* Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
* Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
* Positive urine or serum pregnancy test 24 hours prior to procedure in female patients of child bearing potential
* Known intravenous drug abuse

Primary outcomes:
measure: Kaplan-Meier Freedom From TPV Dysfunction
timeFrame: 5 years
Secondary outcomes:
measure: Freedom From TPV Dysfunction at 10 Years
timeFrame: 10 years
measure: Procedural Success
timeFrame: Within 24 Hours post implant
measure: Serious Procedural Adverse Event (AE)
timeFrame: 5 years
measure: Serious Procedural Adverse Event (AE)
timeFrame: 10 years
measure: Serious Device-related Adverse Event
timeFrame: 5 years
measure: Serious Device-related Adverse Event
timeFrame: 10 years
measure: Kaplan-Meier Freedom From Major Stent Fracture at 5 Years
timeFrame: 5 years
measure: Kaplan-Meier Freedom From Major Stent Fracture at 10 Years
timeFrame: 10 years
measure: Kaplan-Meier Freedom From Catheter Re-intervention on TPV
timeFrame: 5 years
measure: Kaplan-Meier Freedom From Catheter Re-intervention on TPV
timeFrame: 10 years
measure: Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit
timeFrame: 5 years
measure: Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit
timeFrame: 10 years
measure: Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)
timeFrame: 5 years
measure: Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)
timeFrame: 10 years
measure: Functional Assessment (NYHA Classification)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: New York
country: United States
facility: Children's Hospital of NY-Presbyterian
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Seattle
country: United States
facility: Seattle Children's and Regional Hospital
state: Washington
Study officials:
References:
citation: Jones TK, McElhinney DB, Vincent JA, Hellenbrand WE, Cheatham JP, Berman DP, Zahn EM, Khan DM, Rhodes JF Jr, Weng S, Bergersen LJ. Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial. Circ Cardiovasc Interv. 2022 Jan;15(1):e010852. doi: 10.1161/CIRCINTERVENTIONS.121.010852. Epub 2021 Dec 21.
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: Priromprintr B, Silka MJ, Rhodes J, Batra AS. A prospective 5-year study of exercise performance following Melody valve implant. Am Heart J. 2019 Mar;209:47-53. doi: 10.1016/j.ahj.2018.12.014. Epub 2018 Dec 29.
citation: Priromprintr B, Silka MJ, Rhodes J, Batra AS. A prospective 5-year study of the frequency of arrhythmias during serial exercise testing and clinical follow-up after Melody valve implant. Heart Rhythm. 2016 Nov;13(11):2135-2141. doi: 10.1016/j.hrthm.2016.07.023. Epub 2016 Jul 21.
citation: Cheatham JP, Hellenbrand WE, Zahn EM, Jones TK, Berman DP, Vincent JA, McElhinney DB. Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial. Circulation. 2015 Jun 2;131(22):1960-70. doi: 10.1161/CIRCULATIONAHA.114.013588. Epub 2015 May 5.
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.
citation: McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. doi: 10.1161/CIRCINTERVENTIONS.111.965616. Epub 2011 Nov 9.
citation: McElhinney DB, Hellenbrand WE, Zahn EM, Jones TK, Cheatham JP, Lock JE, Vincent JA. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010 Aug 3;122(5):507-16. doi: 10.1161/CIRCULATIONAHA.109.921692. Epub 2010 Jul 19.