Regent China Post-Market Clinical Follow-up Study
Study Details
Study Description
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 Chinese population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population. This is a prospective, observational, multi-center study of subjects clinically indicated for implantation of an Abbott Medical's Regent Valve.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Abbott Regent MHV Subjects implanted with an Abbott Regent MHV replacement of the aortic valve. |
Device: Abbott Mechanical Heart Valve (MHV) Regent™
SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756)
|
Outcome Measures
Primary Outcome Measures
- Freedom from valve-related mortality [Assessed at 5 years]
Freedom from valve-related mortality
- Freedom from valve-related reoperation. [Assessed at 5 years]
Freedom from valve-related reoperation.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is eligible to be implanted with Regent to replace a native or prosthetic aortic valve per Regent's IFU.
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Subject will be >18 years of age at time of being consented.
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Subject, provides written informed consent prior to any clinical investigation-specific procedure.
Exclusion Criteria:
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Subject is unable to tolerate anticoagulation therapy.
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Subject has active endocarditis.
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Subject is currently participating in another clinical investigation which may interfere with the effectiveness of anticoagulation therapy.
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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.
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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.
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Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
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Subject's life expectancy is less than 1 year in the opinion of the Investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | ||
| 5 | Fuwai Central China Cardiovascular Hospital | Zhengzhou | China | ||
| 6 | Affiliated Hospital of Zunyi Medical University | Zunyi | China |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Director: Kyle Brunner, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABT-CIP-10412