At a glance
ClinicalIndex Comparison RecordN/ACompleted· 39 enrolled
Drug / intervention
Melody Transcatheter Pulmonary Valve PB1016device
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.
Melody(TM) Transcatheter Pulmonary Valve PB1016 Surveillance Study Implantation of the Medtronic Melody Transcatheter Pulmonary Valve PB1016 Using the Ensemble(TM) Transcatheter Delivery System in Patients With Dysfunctional RVOT Conduits
In Brief
A clinical study evaluating Melody Transcatheter Pulmonary Valve PB1016 for Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects. Completed, enrolled 39 participants across 8 sites in 4 countries.
Detailed Summary
Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, Spain, United States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedJan 2015
Primary CompletionNov 2016
Study CompletionAug 2018
TodayJul 2026
First PostedJan 27, 2015
Enrollment StartNov 1, 2014
Primary CompletionNov 1, 2016
Study CompletionAug 10, 2018
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.4 years ago
Interventions
Melody Transcatheter Pulmonary Valve PB1016device