Melody® Transcatheter Pulmonary Valve Post-Approval Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01186692 |
Recruitment Status
:
Completed
First Posted
: August 23, 2010
Results First Posted
: December 26, 2016
Last Update Posted
: December 13, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit | Device: Melody® Transcatheter Pulmonary Valve | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 131 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Actual Study Start Date : | July 2010 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | October 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Melody TPV Implant
Melody® Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.
|
Device: Melody® Transcatheter Pulmonary Valve
Transcatheter Pulmonary Valve replacement Transcatheter valve implantation into a RVOT 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
|
- Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation [ Time Frame: 6 months ]
Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following:
- Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and
- Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and
- Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation.
The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.
- Procedural Success [ Time Frame: 6 Months ]
Procedural success is defined as a composite of the following:
- The TPV is fixated within the desired location, and
- The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and
- There is no more than trivial pulmonary regurgitation by angiography
- The subject is free from explantation of the TPV at 24 hours post-implant
- Serious Procedural Adverse Events [ Time Frame: 6 Months ]A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).
- Serious Device-related Adverse Events [ Time Frame: 6 months ]A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).
- Changes in NYHA Functional Classification [ Time Frame: 6 Months ]Change in NYHA functional class from pre-implant to 6 month post-implant

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186692
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 | |
Saint 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 |
Principal Investigator: | Jaqueline Kreutzer, MD | Children's Hospital of University of Pittsburgh Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medtronic Cardiovascular |
ClinicalTrials.gov Identifier: | NCT01186692 History of Changes |
Other Study ID Numbers: |
D03909 |
First Posted: | August 23, 2010 Key Record Dates |
Results First Posted: | December 26, 2016 |
Last Update Posted: | December 13, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |