At a glance
ClinicalIndex Comparison RecordN/ACompleted· 26 enrolled
Drug / intervention
Edwards Pericardial Aortic Bioprosthesis Model 11000Adevice
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.
Prospective, Non-Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
In Brief
A clinical study evaluating Edwards Pericardial Aortic Bioprosthesis Model 11000A for Pulmonary Valve Insufficiency and 2 related conditions. Completed, enrolled 26 participants across 1 site.
Detailed Summary
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedJan 2016
Primary CompletionSep 2018
Study CompletionNov 2022
TodayJul 2026
First PostedJan 14, 2016
Enrollment StartDec 1, 2015
Primary CompletionSep 1, 2018
Study CompletionNov 28, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.5 years ago
Interventions
Edwards Pericardial Aortic Bioprosthesis Model 11000Adevice
Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium