Valvular Heart DiseaseNCT05330468
Regent China Post-Market Clinical Follow-up Study
An observational study of Valvular Heart Disease and Aortic Valve Disease, run by Abbott Medical Devices at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease, Aortic Valve Disease
- What is being tested?
- Abbott Mechanical Heart Valve (MHV) Regent™
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- 29 Mar 2022to 10 Oct 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This clinical investigation will enroll male and female subjects who will be undergoing replacement of a native or prosthetic aortic heart valve. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The People's Hospital of Gaozhou
Gaozhou
The Second Affiliated Hospital of Nanchang University
Nanchang
Ningbo Medical Center Lihuili Hospital
Ningbo
Wuhan Union Hospital of China
Wuhan
Affiliated Hospital of Zunyi Medical University
Zunyi
About this study
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.
Read the 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.
- Conditions
- Valvular Heart Disease, Aortic Valve Disease
- Being tested
- Abbott Mechanical Heart Valve (MHV) Regent™
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott Mechanical Heart Valve (MHV) Regent™Device
SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756)
| Study group | Role | What they receive |
|---|---|---|
| Abbott Regent MHV | Subjects implanted with an Abbott Regent MHV replacement of the aortic valve. Receives: Device: Abbott Mechanical Heart Valve (MHV) Regent™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: The Freedom From Valve-related Mortality
Valve-related mortality is any death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death. Deaths caused by heart failure in patients with advanced myocardial disease and satisfactorily functioning cardiac valves are not counted. Specific causes of valve-related deaths should be reported.
Measured: At one year
Primary Performance Endpoint: The Freedom From Valve-related Reoperation
Valve-related reoperation includes any reintervention that is a surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces the previously implanted prosthesis or repaired valve.
Measured: At one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start29 Mar 2022
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Brunner, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330468
- Sponsor's protocol ID
- ABT-CIP-10412
- Status last verified
- Sep 2025
- First submitted
- 13 Apr 2022
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regent China Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT05330468
- Acronym / sponsor ID
- ABT-CIP-10412
- Conditions
- Valvular Heart Disease, Aortic Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abbott Regent MHV | – | Device: Abbott Mechanical Heart Valve (MHV) Regent™Subjects implanted with an Abbott Regent MHV replacement of the aortic valve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical investigation will enroll male and female subjects who will be undergoing replacement of a native or prosthetic aortic heart valve. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott Mechanical Heart Valve (MHV) Regent™SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756) | Device | Abbott Regent MHV |
Primary outcome
Primary Safety Endpoint: The Freedom From Valve-related Mortality
Time frame: At one year
Valve-related mortality is any death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death. Deaths caused by heart failure in patients with advanced myocardial disease and satisfactorily functioning cardiac valves are not counted. Specific causes of valve-related deaths should be reported.
Primary Performance Endpoint: The Freedom From Valve-related Reoperation
Time frame: At one year
Valve-related reoperation includes any reintervention that is a surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces the previously implanted prosthesis or repaired valve.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Brunner study director
Abbott
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease and Aortic Valve Disease, run by Abbott Medical Devices at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: The Freedom From Valve-related Mortality (time frame: At one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.