At a glance
ClinicalIndex Comparison RecordN/AActive· 1,312 enrolled
Drug / intervention
Model 400 aortic valve bioprosthesisdevice
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.
Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease
In Brief
A clinical study evaluating Model 400 aortic valve bioprosthesis for Aortic Stenosis. Active but no longer recruiting, targeting 1,312 participants across 38 sites in 8 countries.
Detailed Summary
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis
CountriesCanada, France, Germany, Italy, Netherlands, Switzerland, United Kingdom, United States
CollaboratorsMedtronic
Timeline
N/AActive
20142015201620172018201920202021202220232024202520262027202820292030203120322033203420352036
First PostedMar 2014
Enrollment StartMay 2014
Primary CompletionApr 2023
TodayJul 2026
Study CompletionDec 2035
First PostedMar 17, 2014
Enrollment StartMay 12, 2014
Primary CompletionApr 17, 2023
Study CompletionDec 31, 2035
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 12.3 years ago
Interventions
Model 400 aortic valve bioprosthesisdevice