Status:
COMPLETED
Regent China Post-Market Clinical Follow-up Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Valvular Heart Disease
Aortic Valve Disease
Eligibility:
All Genders
18+ years
Brief 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 Ch...
Detailed Description
The purpose of the RC-PMCF study is to meet the post-market clinical followup (PMCF) requirements of the National Medical Products Administration (NMPA). The primary objective of this clinical study i...
Eligibility Criteria
Inclusion
- Patient is eligible to be implanted with Regent to replace a native or prosthetic aortic valve per Regent's IFU.
- Subject will be \>18 years of age at time of being consented.
- Subject, provides written informed consent prior to any clinical investigation-specific procedure.
Exclusion
- Subject is unable to tolerate anticoagulation therapy.
- Subject has active endocarditis.
- Subject is currently participating in another clinical investigation which may interfere with the effectiveness of anticoagulation therapy.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Women of child-bearing potential must have a documented negative pregnancy test within one week prior to enrollment.
- Subject has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
- Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
- Subject's life expectancy is less than 1 year in the opinion of the Investigator.
Key Trial Info
Start Date :
March 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05330468
Start Date
March 29 2022
End Date
October 10 2024
Last Update
October 27 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
The People's Hospital of Gaozhou
Gaozhou, China
2
The Second Affiliated Hospital of Nanchang University
Nanchang, China
3
Ningbo Medical Center Lihuili Hospital
Ningbo, China
4
Wuhan Union Hospital of China
Wuhan, China