Aortic Valve Disease, Valvular Heart Disease
Conditions
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.
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.
Interventions
DEVICEAbbott Mechanical Heart Valve (MHV) Regent™
SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756)
Sponsors
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is eligible to be implanted with Regent to replace a native or prosthetic aortic valve per Regent's IFU. 2. Subject will be \>18 years of age at time of being consented. 3. Subject, provides written informed consent prior to any clinical investigation-specific procedure.
Exclusion criteria
1. Subject is unable to tolerate anticoagulation therapy. 2. Subject has active endocarditis. 3. Subject is currently participating in another clinical investigation which may interfere with the effectiveness of anticoagulation therapy. 4. 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. 5. 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. 6. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent. 7. Subject's life expectancy is less than 1 year in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: The Freedom From Valve-related Mortality | 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 | 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. |
Countries
China
Participant flow
Recruitment details
A total of 200 subjects were enrolled across 5 investigational sites between 2022 and 2023. Each subject received a Regent MHV implant. Abbott obtained agreement from the Regulatory Bodies to reduce the follow-up period to one year. The final subject follow-up visit occurred in October of 2024.
Participants by arm
| Arm | Count |
|---|---|
| Abbott Regent MHV Subjects implanted with an Abbott Regent MHV replacement of the aortic valve.
Abbott Mechanical Heart Valve (MHV) Regent™: SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756) | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Abbott Regent MHV | — |
|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 9.5 | — |
| Aortic Regurgitation | 167 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment China | 200 participants | — |
| Sex: Female, Male Female | 93 Participants | — |
| Sex: Female, Male Male | 107 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 200 |
| other Total, other adverse events | 10 / 200 |
| serious Total, serious adverse events | 67 / 200 |
Outcome results
Primary
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.
Time frame: At one year
Population: The analysis population included all subjects who provided written informed consent and underwent an implant of a Regent MHV device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abbott Regent MHV | Primary Performance Endpoint: The Freedom From Valve-related Reoperation | 99.5 percentage of participants |
Primary
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.
Time frame: At one year
Population: The analysis population included all subjects who provided written informed consent and underwent an implant of a Regent MHV device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abbott Regent MHV | Primary Safety Endpoint: The Freedom From Valve-related Mortality | 98.4 percentage of participants |