Status:
COMPLETED
Melody® Transcatheter Pulmonary Valve Post-Approval Study
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit
Eligibility:
All Genders
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT01186692
Start Date
July 1 2010
End Date
October 1 2017
Last Update
May 1 2019
Active Locations (10)
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1
Rady Children's Hospital
San Diego, California, United States, 92123
2
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
3
CS Mott Children's Hospital, University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201