At a glance
ClinicalIndex Comparison RecordN/ACompleted· 131 enrolled
Drug / intervention
Melody® Transcatheter Pulmonary Valvedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study
In Brief
A clinical study evaluating Melody® Transcatheter Pulmonary Valve for Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit. Completed, enrolled 131 participants across 10 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedAug 2010
Primary CompletionJan 2013
Study CompletionOct 2017
TodayJul 2026
First PostedAug 23, 2010
Enrollment StartJul 1, 2010
Primary CompletionJan 1, 2013
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.9 years ago
Interventions
Melody® Transcatheter Pulmonary Valvedevice
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.