At a glance
ClinicalIndex Comparison RecordN/ACompleted· 200 enrolled
Drug / intervention
Abbott Mechanical Heart Valve (MHV) Regent™device
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.
Regent China Post-Market Clinical Follow-up Study
In Brief
An observational study evaluating Abbott Mechanical Heart Valve (MHV) Regent™ for Valvular Heart Disease and Aortic Valve Disease. Completed, enrolled 200 participants across 5 sites.
Detailed Summary
Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsValvular Heart Disease, Aortic Valve Disease
CountriesChina
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
Enrollment StartMar 2022
First PostedApr 2022
Primary CompletionOct 2024
TodayJul 2026
First PostedApr 15, 2022
Enrollment StartMar 29, 2022
Primary CompletionOct 10, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.2 years ago
Interventions
Abbott Mechanical Heart Valve (MHV) Regent™device
SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756)