Trial Outcomes & Findings for Regent China Post-Market Clinical Follow-up Study (NCT NCT05330468)
NCT ID: NCT05330468
Last Updated: 2025-10-27
Results Overview
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.
COMPLETED
200 participants
At one year
2025-10-27
Participant Flow
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.
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
186
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Abbott Regent MHV
n=200 Participants
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)
|
|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 9.5 • n=200 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=200 Participants
|
|
Region of Enrollment
China
|
200 participants
n=200 Participants
|
|
Aortic Regurgitation
|
167 Participants
n=200 Participants
|
PRIMARY outcome
Timeframe: At one yearPopulation: The analysis population included all subjects who provided written informed consent and underwent an implant of a Regent MHV device.
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.
Outcome measures
| Measure |
Abbott Regent MHV
n=200 Participants
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)
|
|---|---|
|
Primary Safety Endpoint: The Freedom From Valve-related Mortality
|
98.4 percentage of participants
Interval 95.2 to 99.5
|
PRIMARY outcome
Timeframe: At one yearPopulation: The analysis population included all subjects who provided written informed consent and underwent an implant of a Regent MHV device.
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.
Outcome measures
| Measure |
Abbott Regent MHV
n=200 Participants
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)
|
|---|---|
|
Primary Performance Endpoint: The Freedom From Valve-related Reoperation
|
99.5 percentage of participants
Interval 96.3 to 99.9
|
Adverse Events
Abbott Regent MHV
Serious adverse events
| Measure |
Abbott Regent MHV
n=200 participants at risk
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)
|
|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.0%
2/200 • At one year
|
|
Cardiac disorders
Arrhythmia
|
2.0%
4/200 • At one year
|
|
Cardiac disorders
Atrial Fibrillation
|
0.50%
1/200 • At one year
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.50%
1/200 • At one year
|
|
Cardiac disorders
Cardiac Failure
|
2.0%
4/200 • At one year
|
|
Cardiac disorders
Cardiac Tamponade
|
0.50%
1/200 • At one year
|
|
Cardiac disorders
Cardiogenic Shock
|
0.50%
1/200 • At one year
|
|
Cardiac disorders
Cardiorenal Syndrome
|
0.50%
1/200 • At one year
|
|
Cardiac disorders
Low Cardiac Output Syndrome
|
0.50%
1/200 • At one year
|
|
Cardiac disorders
Pericardial Effusion
|
1.0%
2/200 • At one year
|
|
Cardiac disorders
Ventricular Fibrillation
|
1.0%
2/200 • At one year
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.50%
1/200 • At one year
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/200 • At one year
|
|
General disorders
Chest Discomfort
|
0.50%
1/200 • At one year
|
|
General disorders
Death
|
0.50%
1/200 • At one year
|
|
General disorders
Impaired Healing
|
0.50%
1/200 • At one year
|
|
General disorders
Paravalvular Regurgitation
|
0.50%
1/200 • At one year
|
|
General disorders
Pyrexia
|
0.50%
1/200 • At one year
|
|
Infections and infestations
Fungal Infection
|
0.50%
1/200 • At one year
|
|
Infections and infestations
Infection
|
2.0%
4/200 • At one year
|
|
Infections and infestations
Periodontitis
|
0.50%
1/200 • At one year
|
|
Infections and infestations
Pneumonia
|
0.50%
1/200 • At one year
|
|
Infections and infestations
Pneumonia Bacterial
|
0.50%
1/200 • At one year
|
|
Infections and infestations
Postoperative Wound Infection
|
0.50%
1/200 • At one year
|
|
Infections and infestations
Respiratory Tract Infection
|
1.0%
2/200 • At one year
|
|
Infections and infestations
Sinusitis
|
0.50%
1/200 • At one year
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.50%
1/200 • At one year
|
|
Infections and infestations
Urinary Tract Infection
|
0.50%
1/200 • At one year
|
|
Injury, poisoning and procedural complications
Foreign Body in Gastrointestinal Tract
|
0.50%
1/200 • At one year
|
|
Investigations
Coagulation Test Abnormal
|
1.0%
2/200 • At one year
|
|
Investigations
International Normalised Ratio Increased
|
0.50%
1/200 • At one year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.50%
1/200 • At one year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Liver
|
0.50%
1/200 • At one year
|
|
Nervous system disorders
Headache
|
0.50%
1/200 • At one year
|
|
Nervous system disorders
Ischemic Stroke
|
0.50%
1/200 • At one year
|
|
Renal and urinary disorders
Calculus Urinary
|
0.50%
1/200 • At one year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.50%
1/200 • At one year
|
|
Renal and urinary disorders
Renal Cyst
|
0.50%
1/200 • At one year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.0%
2/200 • At one year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
2/200 • At one year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax Spontaneous
|
0.50%
1/200 • At one year
|
|
Vascular disorders
Arterial Insufficiency
|
0.50%
1/200 • At one year
|
|
Vascular disorders
Hemorrhage
|
3.5%
7/200 • At one year
|
|
Vascular disorders
Vasculitis Necrotising
|
0.50%
1/200 • At one year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.50%
1/200 • At one year
|
Other adverse events
| Measure |
Abbott Regent MHV
n=200 participants at risk
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)
|
|---|---|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.50%
1/200 • At one year
|
|
Cardiac disorders
Arrhythmia
|
1.0%
2/200 • At one year
|
|
Cardiac disorders
Atrial Fibrillation
|
0.50%
1/200 • At one year
|
|
Cardiac disorders
Atrial Flutter
|
0.50%
1/200 • At one year
|
|
Cardiac disorders
Cardiac Failure
|
0.50%
1/200 • At one year
|
|
General disorders
Chest Discomfort
|
0.50%
1/200 • At one year
|
|
Nervous system disorders
Ischaemic Stroke
|
1.0%
2/200 • At one year
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.50%
1/200 • At one year
|
Additional Information
Director, Clinical Programs Structural Interventions & Cardiac Surgery
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER