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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abbott Regent MHV | Subjects implanted with an Abbott Regent MHV replacement of the aortic valve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbott Mechanical Heart Valve (MHV) Regentâ„¢ | Device | SJM Regentâ„¢- Standard cuff (Model number AGN-751); SJM Regentâ„¢- FlexCuffâ„¢ (Model number AGFN-756) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At one year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Brunner | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The People's Hospital of Gaozhou | Gaozhou | China | ||||
| The Second Affiliated Hospital of Nanchang University |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abbott Regent MHV | Subjects implanted with an Abbott Regent MHV replacement of the aortic valve. Abbott Mechanical Heart Valve (MHV) Regentâ„¢: SJM Regentâ„¢- Standard cuff (Model number AGN-751); SJM Regentâ„¢- FlexCuffâ„¢ (Model number AGFN-756) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abbott Regent MHV | Subjects implanted with an Abbott Regent MHV replacement of the aortic valve. Abbott Mechanical Heart Valve (MHV) Regentâ„¢: SJM Regentâ„¢- Standard cuff (Model number AGN-751); SJM Regentâ„¢- FlexCuffâ„¢ (Model number AGFN-756) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis population included all subjects who provided written informed consent and underwent an implant of a Regent MHV device. | Posted | Number | 95% Confidence Interval | percentage of participants | At one year |
|
At one year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abbott Regent MHV | Subjects implanted with an Abbott Regent MHV replacement of the aortic valve. Abbott Mechanical Heart Valve (MHV) Regentâ„¢: SJM Regentâ„¢- Standard cuff (Model number AGN-751); SJM Regentâ„¢- FlexCuffâ„¢ (Model number AGFN-756) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic Valve Incompetence | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Programs Structural Interventions & Cardiac Surgery | Abbott | (651)-202-8362 | ryan.palmer@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2022 | Sep 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2022 | Sep 23, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Nanchang |
| China |
| Ningbo Medical Center Lihuili Hospital | Ningbo | China |
| Wuhan Union Hospital of China | Wuhan | China |
| Affiliated Hospital of Zunyi Medical University | Zunyi | China |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Aortic Regurgitation | Count of Participants | Participants |
|
|
|
| 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. | The analysis population included all subjects who provided written informed consent and underwent an implant of a Regent MHV device. | Posted | Number | 95% Confidence Interval | percentage of participants | At one year |
|
|
|
| 6 |
| 200 |
| 67 |
| 200 |
| 10 |
| 200 |
| Arrhythmia | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Atrioventricular Block Complete | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Cardiac Tamponade | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Cardiogenic Shock | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Cardiorenal Syndrome | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Low Cardiac Output Syndrome | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Ventricular Fibrillation | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Inguinal Hernia | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA (27.1) | Systematic Assessment |
|
| Death | General disorders | MedDRA (27.1) | Systematic Assessment |
|
| Impaired Healing | General disorders | MedDRA (27.1) | Systematic Assessment |
|
| Paravalvular Regurgitation | General disorders | MedDRA (27.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (27.1) | Systematic Assessment |
|
| Fungal Infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
|
| Pneumonia Bacterial | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Postoperative Wound Infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
|
| Foreign Body in Gastrointestinal Tract | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
|
| Coagulation Test Abnormal | Investigations | MedDRA (27.1) | Systematic Assessment |
|
| International Normalised Ratio Increased | Investigations | MedDRA (27.1) | Systematic Assessment |
|
| Colon Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
|
| Metastases to Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
|
| Ischemic Stroke | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
|
| Calculus Urinary | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
|
| Renal Cyst | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
|
| Pneumothorax Spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
|
| Arterial Insufficiency | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
|
| Hemorrhage | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
|
| Vasculitis Necrotising | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA (27.1) | Systematic Assessment |
|
| Ischaemic Stroke | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
|
The disclosure restrictions on the PI is that 1) following the earliest of (i) the sponsor's trial results disclosure; or (ii) twelve months after study completion/termination at all study sites, the PI shall publish trial results; 2) the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is equal to or more than 60 days from the time submitted to the sponsor for review.