Heart Valve Diseases
Conditions
Keywords
Aortic valve insufficiency, Aortic valve, Aortic disease, Aortic incompetence
Brief summary
This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Detailed description
Bioprosthetic heart valves offer several advantages over mechanical valves, the most important being freedom from the need for anticoagulation and a low rate of thromboembolic events. Pericardial bioprosthetic valves are known to have hemodynamic performance superior to porcine valves, and the excellent hemodynamic performance of pericardial valves is particularly relevant in patients with a small aortic root. However, long-term durability continues to be the main concern with use of pericardial valves. Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation techniques and design failure rather than the pericardial tissue.The unique desing of the Mitroflow Aortic Heart Valve may provide superior hemodynamic performance over other tissue valves.
Interventions
DEVICEMitroflow Aortic Heart Valve
Replacement of the native aortic valve or a previously implanted prosthetic aortic valve
Sponsors
Sorin Group USA, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is male or female 18 years old or older * The subject or subject's legal representative is willing to sign the informed consent * A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve or prosthesis accord gin to the current medical practice for valve selection at the center * The subject is able to return for all follow-up evaluations for the duration of the study (i.e. geographically stable
Exclusion criteria
* The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position * The patient requires a double or triple valve replacement * The patient had a Mitroflow Heart valve during the clinical study but who then had the valve explanted * The patient has active endocarditis * The subject is or will be participating in a concomitant research study of an investigational product * The subject is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent * The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient the patient is pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Late postoperative | Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring \>30 days after valve implant. |
| Mean Gradient | 12 months | Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size. |
| Effective Orifice Area | 12 months | Effective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aortic Valve Regurgitation | 12 months | Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mitroflow Aortic Pericardial Valve Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol. | 699 |
| Total | 699 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 110 |
| Overall Study | Explant | 8 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Physician Decision | 47 |
| Overall Study | Protocol Violation | 7 |
| Overall Study | Withdrawal by Subject | 30 |
Baseline characteristics
| Characteristic | Mitroflow Aortic Pericardial Valve |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 603 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants |
| Age Continuous | 74.3 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment Canada | 143 participants |
| Region of Enrollment United States | 556 participants |
| Sex: Female, Male Female | 302 Participants |
| Sex: Female, Male Male | 397 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 430 / 699 |
| serious Total, serious adverse events | 351 / 699 |
Outcome results
Primary
Effective Orifice Area
Effective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mitroflow Aortic Pericardial Valve | Effective Orifice Area | Valve Size 19 | 1.1 cm^2 | Standard Deviation 0.2 |
| Mitroflow Aortic Pericardial Valve | Effective Orifice Area | Valve Size 21 | 1.2 cm^2 | Standard Deviation 0.3 |
| Mitroflow Aortic Pericardial Valve | Effective Orifice Area | Valve Size 23 | 1.4 cm^2 | Standard Deviation 0.3 |
| Mitroflow Aortic Pericardial Valve | Effective Orifice Area | Valve Size 25 | 1.6 cm^2 | Standard Deviation 0.3 |
| Mitroflow Aortic Pericardial Valve | Effective Orifice Area | Valve Size 27 | 1.8 cm^2 | Standard Deviation 0.3 |
| Mitroflow Aortic Pericardial Valve | Effective Orifice Area | Valve Size 29 | 2 cm^2 | Standard Deviation 0.1 |
Primary
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring \>30 days after valve implant.
Time frame: Late postoperative
Population: Cumulative follow-up in years occurring post 30 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Major thromboembolic event | 0.49 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Valve thrombosis | 0 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | All mortality | 7.1 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Valve-related mortality | 1.27 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Structural valve deterioration | 0.21 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Major anticoagulant-related bleeding | 0.56 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Thromboembolism | 1.34 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Endocarditis | 1.41 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Non-structural valve dysfunction | 0.75 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Perivalvular leak | 0.63 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Hemolysis | 0 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Valve reoperation | 0.85 Percent occurrence per patient-year |
| Mitroflow Aortic Pericardial Valve | Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair | Valve explant | 0.77 Percent occurrence per patient-year |
Primary
Mean Gradient
Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size.
Time frame: 12 months
Population: Patients with 12 month hemodynamic evaluations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mitroflow Aortic Pericardial Valve | Mean Gradient | Valve Size 19 | 13.4 mmHg | Standard Deviation 5 |
| Mitroflow Aortic Pericardial Valve | Mean Gradient | Valve Size 21 | 11.4 mmHg | Standard Deviation 4.4 |
| Mitroflow Aortic Pericardial Valve | Mean Gradient | Valve Size 23 | 10.5 mmHg | Standard Deviation 4.2 |
| Mitroflow Aortic Pericardial Valve | Mean Gradient | Valve Size 25 | 8.6 mmHg | Standard Deviation 3.3 |
| Mitroflow Aortic Pericardial Valve | Mean Gradient | Valve Size 27 | 7.3 mmHg | Standard Deviation 2.7 |
| Mitroflow Aortic Pericardial Valve | Mean Gradient | Valve Size 29 | 7.3 mmHg | Standard Deviation 1.8 |
Secondary
Aortic Valve Regurgitation
Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mitroflow Aortic Pericardial Valve | Aortic Valve Regurgitation | None | 74.3 Percent of participants |
| Mitroflow Aortic Pericardial Valve | Aortic Valve Regurgitation | Trace | 16.2 Percent of participants |
| Mitroflow Aortic Pericardial Valve | Aortic Valve Regurgitation | Mild | 8.6 Percent of participants |
| Mitroflow Aortic Pericardial Valve | Aortic Valve Regurgitation | Moderate | 0.9 Percent of participants |
| Mitroflow Aortic Pericardial Valve | Aortic Valve Regurgitation | Severe | 0 Percent of participants |