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Melody® Transcatheter Pulmonary Valve Post-Approval Study
This study is ongoing, but not recruiting participants.
Sponsor:
Medtronic Cardiovascular
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01186692
First received: August 20, 2010
Last updated: April 18, 2017
Last verified: April 2017
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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 Right Ventricular Outflow Tract (RVOT) Conduit | Device: Melody® Transcatheter Pulmonary Valve |
| Study Type: | Interventional |
| Study Design: | 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 |
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 ]
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.
Secondary Outcome Measures:
- 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
| 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 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
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| 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 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
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
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 | |
| 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 | |
Sponsors and Collaborators
Medtronic Cardiovascular
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):
| Responsible Party: | Medtronic Cardiovascular |
| ClinicalTrials.gov Identifier: | NCT01186692 History of Changes |
| Other Study ID Numbers: |
D03909 |
| Study First Received: | August 20, 2010 |
| Results First Received: | September 30, 2016 |
| Last Updated: | April 18, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
ClinicalTrials.gov processed this record on August 18, 2017