Status:
COMPLETED
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Congenital Heart Defects
Dysfunctional Right Ventricular Outflow Tract Conduits
Eligibility:
All Genders
5+ years
Phase:
NA
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. Th...
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2020
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00740870
Start Date
January 1 2007
End Date
August 21 2020
Last Update
March 26 2024
Active Locations (5)
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1
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
2
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
3
Children's Hospital of NY-Presbyterian
New York, New York, United States, 10032
4
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205