Mitral Heart Valve Disease Clinical Trial
Official title:
Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
| NCT number | NCT01312779 |
| Other study ID # | 2008-07 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2011 |
| Est. completion date | November 2018 |
| Verified date | March 2020 |
| Source | Edwards Lifesciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | November 2018 |
| Est. primary completion date | November 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 13 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patient has mitral valve disease requiring surgical replacement 2. Patient has provided written informed consent prior to mitral valve surgery 3. Patient is expected to survive surgery and be discharged 4. Patient is willing to comply with specified follow-up evaluations 5. Patient is 13 years of age or older Exclusion Criteria: 1. Patient has life expectancy < 12 months due to non-cardiac co-morbid conditions; 2. Patient has/had active endocarditis within the last 3 months 3. Patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve; 4. Patient was previously enrolled and implanted in the study 5. Patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ 6. Patient has a body surface area (BSA) > 1.9m2 7. Female patients who are pregnant, planning to become pregnant, or lactating 8. Patient has a documented history of substance ( drug or alcohol) abuse 9. Patient is currently a prison inmate 10. Patient is currently participating in an investigational drug or another device study 11. Patient is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism 12. Patient has active myocarditis 13. Patient has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event and has not returned to baseline or stabilized > 30 days prior to the planned v alve implant surgery 14. Patient has an abnormality such as an aortic aneurysm (e.g. due to cystic medial necrosis or Marfan's syndrome), aortic dissection, or ventricular aneurysm that might place |
| Country | Name | City | State |
|---|---|---|---|
| Poland | The John Paul II Hospital in Krakow | Krakow | |
| United States | Cooper University Hospital | Camden | New Jersey |
| United States | Northwestern Hospital | Chicago | Illinois |
| United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
| United States | Florida Hospital | Orlando | Florida |
| United States | Washington University | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Edwards Lifesciences |
United States, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Subject's Average Mean Gradient Measurement | Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. | Pre-procedure and 1 Year post-implant | |
| Other | Subject's Average Peak Gradient Measurement | Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. | Pre-procedure and 1 Year post-implant | |
| Other | Subject's Average Effective Orifice Area Index (EOAI) Measurement | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. | Pre-procedure and 1 Year post-implant | |
| Other | Subject's Average Performance Index Measurement | Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time. | Pre-procedure and 1 Year post-Implant | |
| Other | Subject's Average Cardiac Output | The amount of blood the heart pumps through the circulatory system in a minute. | Pre-procedure and 1 Year post-implant | |
| Other | Subject's Average Cardiac Index | Cardiac index is an assessment that divides the cardiac output from the left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. | Pre-procedure and 1 Year post-implant | |
| Other | Subject's Average Left Ventricular Mass Regression | Patients can experience an enlargement of the left ventricle (chamber) of their heart because it works harder with a defective heart valve. Left ventricular mass regression evaluates if the patient experiences a decrease in the size of the left ventricle (chamber) after the repair or replacement of their heart valve. | Pre-procedure and 1 Year post-implant | |
| Other | Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant. | Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. | 1 Year post-implant | |
| Other | Subject's Average Red Blood Cells Count | Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen. | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | |
| Other | Subject's Average White Blood Cell Count | Laboratory analysis of White Blood Cell (WBC) Count on blood drawn from subject; WBC fight infection. | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | |
| Other | Subject's Average Hematocrit Percentage | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood). | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | |
| Other | Subject's Average Plasma Free Hemoglobin | Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | |
| Other | Subject's Average Hemoglobin Count | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | |
| Other | Subject's Average Platelet Count | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. | Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | |
| Other | Number and Percentage of Subjects in NYHA Functional Class I or II at 1 Year Post-Implant. | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). |
Baseline and 1 Year post-implant | |
| Other | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. |
6 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | |
| Other | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. | 6 Months and 1 Year post-implant | |
| Primary | Percent of Early Adverse Events Divided | Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100. | Events occuring within 30 days of procedure | |
| Primary | Percent of Late Adverse Events | Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | Events occurring >= 31 days and up through 5 years post-implant | |
| Primary | Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method. | >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant | |
| Primary | Subject's Average Effective Orifice Area (EOA) Measurement | Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time. | Pre-procedure and 1 Year post-Implant |