At a glance
ClinicalIndex Comparison RecordN/AActive· 101 enrolled
Drug / intervention
TAVR with CENTERA THVdevice
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.
A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
In Brief
A clinical study evaluating TAVR with CENTERA THV for Aortic Valve Stenosis. Active but no longer recruiting, targeting 101 participants across 23 sites.
Detailed Summary
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesUnited States
Collaborators--
Timeline
N/AActive
201920202021202220232024202520262027202820292030
First PostedMay 2018
Enrollment StartSep 2018
Primary CompletionOct 2020
TodayJul 2026
Study CompletionJul 2030
First PostedMay 7, 2018
Enrollment StartSep 18, 2018
Primary CompletionOct 2, 2020
Study CompletionJul 1, 2030
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.2 years ago
Interventions
TAVR with CENTERA THVdevice
TAVR with the Edwards CENTERA THV System