Melody® Transcatheter Pulmonary Valve Post-Approval Study - Full Text View

Purpose

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.

Condition	Intervention
Dysfunctional RVOT Conduit	Device: Melody® Transcatheter Pulmonary Valve


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:

Acceptable TPV hemodynamic function at six months after successful TPV implantation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

% of patients with procedural success [ Time Frame: 5 year ] [ Designated as safety issue: No ]
% of subjects with serious procedural adverse events [ Time Frame: 5 year ] [ Designated as safety issue: No ]
% of subjects with serious device-related adverse events at six months post-implant [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of serious device-related adverse events over the follow-up period [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Freedom from stent fracture [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Freedom from reintervention on the TPV [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Freedom from RVOT conduit reoperation [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Freedom from death (all-cause, procedural, and device-related) [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Changes in NYHA functional classification [ Time Frame: 5 year ] [ Designated as safety issue: No ]


Enrollment:	131
Study Start Date:	July 2010
Estimated Study Completion Date:	July 2017
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Melody TPV Implant Melody® Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PA Conduit.	Device: Melody® Transcatheter Pulmonary Valve Transcatheter Pulmonary Valve replacement Transcatheter valve implantation into a RVPA conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention. Other Name: Melody Transcatheter Pulmonary Valve

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 Right Ventricular Outflow Tract conduits with a clinical indication for interventions (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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186692

Locations


United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Illinois
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
United States, Michigan
CS Mott Children's Hospital, University of Michigan
Ann Arbor, Michigan, United States, 48109
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15201
United States, Texas
Children's Medical Center Dallas, UT Southwestern
Dallas, Texas, United States, 75235
United States, Utah
Primary Children's Medical Center, University of Utah
Salt Lake City, Utah, United States, 84113

Sponsors and Collaborators

Medtronic Heart Valves

Investigators


Principal Investigator:	Jaqueline Kreutzer, MD	Children's Hospital of University of Pittsburgh Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


Responsible Party:	Medtronic Heart Valves
ClinicalTrials.gov Identifier:	NCT01186692 History of Changes
Other Study ID Numbers:	D03909
Study First Received:	August 20, 2010
Last Updated:	April 29, 2016
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 26, 2016