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The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of five years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDWARDS INTUITY valve | Experimental | All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDWARDS INTUITY valve | Device | Surgical replacement of the aortic valve with the EDWARDS INTUITY valve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100] | Events occurring ≥ 31 days and up through 8 years post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success | Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place. | Day of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status. | Baseline and one year follow-up |
Inclusion Criteria:
Inclusion Criteria - Subjects will be required to meet all inclusion criteria:
Exclusion Criteria:
- Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present:
Pure aortic insufficiency
Requires emergency surgery
Previous aortic valve replacement
Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
Requires multiple valve replacement/repair
Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal)
Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery
Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery
Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis
Hyperparathyroidism
MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure
Presence of non-cardiac disease limiting life expectancy to less than 12 months
Hypertrophic obstructive cardiomyopathy (HOCM)
Left ventricular ejection fraction ≤ 25%
Documented history of substance (drug or alcohol) abuse within the last 5 years
Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure
Pregnancy, lactation, or planning to become pregnant;
Currently incarcerated or unable to give voluntary informed consent
Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding diathesis or coagulopathy
History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome)
Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial
Anatomic variances which contraindicate implant of the trial valve, such as:
Available devices are not suitably sized for the subject's annulus
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Barnhart, MD | Swedish Medical Center | Principal Investigator |
| Walter Randolph Chitwood, MD | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Hospital of University of Southern California | Los Angeles | California | 90033 | United States | ||
| University of California Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27817951 | Result | Barnhart GR, Accola KD, Grossi EA, Woo YJ, Mumtaz MA, Sabik JF, Slachman FN, Patel HJ, Borger MA, Garrett HE Jr, Rodriguez E, McCarthy PM, Ryan WH, Duhay FG, Mack MJ, Chitwood WR Jr; TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017 Feb;153(2):241-251.e2. doi: 10.1016/j.jtcvs.2016.09.062. Epub 2016 Oct 15. | |
| 29705366 |
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Individual participant data will not be available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Edwards TRANSFORM Trial Cohort | Subjects who were enrolled in the TRANSFORM trial and were eligible to receive an INTUITY study surgical aortic heart valve. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2017 |
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| Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success |
Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first. |
| Day of procedure through discharge or 10 days post index procedure, whichever comes first. |
| Average Amount of Time Subject Spent on Cardiopulmonary Bypass | Surgical and hospitalization factors - Cardiopulmonary bypass time | Day of procedure |
| Average Subject Time on Cardiopulmonary Cross Clamp | Surgical and hospitalization factors - Cardiopulmonary cross clamp time | Day of procedure |
| Average Number of Days Subjects Were in the Intensive Care Unit (ICU) | Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure. | Day of procedure through discharge from the hospital |
| Subject's New York Heart Association (NYHA) Classification Over Time | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. | Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years |
| Subject's Average Mean Gradient Measurements Over Time | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up |
| Subject's Average Peak Gradient Measurements Over Time | Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up |
| Subject's Effective Orifice Area (EOA) Measurement Over Time | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 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. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Subject's Performance Index Measurement Over Time | Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Subject's Cardiac Output Measurement at Over Time | Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Subject's Cardiac Index Measurement Over Time | Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Valvular regurgitation occurs when the 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. 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. Higher numbers on the scale show a worsening outcome. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Subject's Average White Blood Cell Count Over Time |
Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10 10^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong. |
| Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Subject's Average Red Blood Cell Count Over Time | The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10^6 cells/microliters and for men is 4.7 to 6.1 10^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Subject's Average Hematocrit Percentage Over Time | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Subject's Average Hemoglobin Percentage Over Time | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Subject's Average Plasma Free Hemoglobin Over Time | Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong. | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
| Los Angeles |
| California |
| 90095 |
| United States |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| The University of Michigan Medical School | Ann Arbor | Michigan | 48109 | United States |
| Washington University - Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| North Shore Long Island Jewish Health System | Manhasset | New York | 11030 | United States |
| New York University Medical Center | New York | New York | 10016 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Mission Hospital | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Pinnacle Health at Harrisburg Hospital | Harrisburg | Pennsylvania | 17010 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| St. Thomas Health | Nashville | Tennessee | 37205 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Aurora St Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Result |
| Romano MA, Koeckert M, Mumtaz MA, Slachman FN, Patel HJ, Chitwood WR Jr, Barnhart GR, Grossi EA; TRANSFORM Trial Investigators. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. Ann Thorac Surg. 2018 Sep;106(3):685-690. doi: 10.1016/j.athoracsur.2018.03.055. Epub 2018 Apr 26. |
| Study Valve Group |
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| Discharge |
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| 3 Month |
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| 1 Year |
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| 2 Year |
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| 3 Year |
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| 4 Year |
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| 5 Year |
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| 6 Year |
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| 7 Year |
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| 8 Year |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Edwards TRANSFORM Trial Cohort | Subjects who were enrolled in the TRANSFORM trial and were eligible to receive an Edwards INTUITY surgical aortic heart valve. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort | Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100] | The group of subjects that received the Edwards INTUITY surgical aortic heart valve. | Posted | Number | Percentage of events/late patient years | Events occurring ≥ 31 days and up through 8 years post-implant |
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| Secondary | Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success | Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place. | Patients who were eligible to receive an Edwards INTUITY surgical aortic heart valve. | Posted | Number | Percentage of subjects | Day of procedure |
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| Secondary | Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success | Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first. | Patients who were eligible to receive an Edwards INTUITY surgical aortic heart valve. | Posted | Number | Percentage of subjects | Day of procedure through discharge or 10 days post index procedure, whichever comes first. |
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| Secondary | Average Amount of Time Subject Spent on Cardiopulmonary Bypass | Surgical and hospitalization factors - Cardiopulmonary bypass time | The group of subjects that received the Edwards INTUITY surgical aortic heart valve. | Posted | Mean | Standard Deviation | Minutes | Day of procedure |
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| Secondary | Average Subject Time on Cardiopulmonary Cross Clamp | Surgical and hospitalization factors - Cardiopulmonary cross clamp time | The group of subjects that received the Edwards INTUITY surgical aortic heart valve. Data is not available for one subject. | Posted | Mean | Standard Deviation | Minutes | Day of procedure |
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| Secondary | Average Number of Days Subjects Were in the Intensive Care Unit (ICU) | Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure. | The group of subjects that received the Edwards INTUITY surgical aortic heart valve. Data is not available for 4 subjects. | Posted | Mean | Standard Deviation | Days | Day of procedure through discharge from the hospital |
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| Secondary | Subject's New York Heart Association (NYHA) Classification Over Time | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Count of Participants | Participants | Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years |
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| Secondary | Subject's Average Mean Gradient Measurements Over Time | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | mmHg | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up |
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| Secondary | Subject's Average Peak Gradient Measurements Over Time | Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | mmHg | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up |
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| Secondary | Subject's Effective Orifice Area (EOA) Measurement Over Time | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | Centimeters squared | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
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| Secondary | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time | 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. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | centimeters squared/meters squared | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
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| Secondary | Subject's Performance Index Measurement Over Time | Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | Centimeters squared/meters squared | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
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| Secondary | Subject's Cardiac Output Measurement at Over Time | Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | Liters/minutes | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
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| Secondary | Subject's Cardiac Index Measurement Over Time | Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | Liters/minutes/meters squared | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
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| Secondary | Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size | Valvular regurgitation occurs when the 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. 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. Higher numbers on the scale show a worsening outcome. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Count of Participants | Participants | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
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| Other Pre-specified | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey | The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available at both the baseline and 1 year follow-up visits. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and one year follow-up |
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| Other Pre-specified | Subject's Average White Blood Cell Count Over Time | Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10 10^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | 10^3 cells/microliters | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
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| Other Pre-specified | Subject's Average Red Blood Cell Count Over Time | The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10^6 cells/microliters and for men is 4.7 to 6.1 10^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | 10^6 cells/microliters | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Hematocrit Percentage Over Time | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | Percentage of RBC | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Hemoglobin Percentage Over Time | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | g/dL | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Subject's Average Plasma Free Hemoglobin Over Time | Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong. | This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. | Posted | Mean | Standard Deviation | mg/dL | Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up |
|
|
Events occurring from the day of aortic heart valve surgery up through 8 years post implant.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Edwards TRANSFORM INTUITY Aortic Valve Study Cohort | The data from the 885 subjects who received the investigational Edwards INTUITY surgical aortic heart valve. | 178 | 885 | 756 | 885 | 868 | 885 |
| EG001 | Commercially Available Aortic Valve Study Cohort | The data from the 49 subjects who received an alternate FDA approved surgical aortic heart valve. | 8 | 49 | 37 | 49 | 47 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA - BLEEDING RELATED - MAJOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| ANEMIA - BLEEDING RELATED - MINOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| ANEMIA - NON-BLEEDING RELATED | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - CARDIOVASCULAR - MAJOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - CARDIOVASCULAR - MINOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - GASTROINTESTINAL LOWER - MAJOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - GASTROINTESTINAL LOWER - MINOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - GASTROINTESTINAL UPPER - MAJOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - GASTROINTESTINAL UPPER - MINOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - GENITOURINARY - MAJOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - GENITOURINARY - MINOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL - MAJOR (E.G. ECCHYMOSIS) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL - MINOR (E.G. ECCHYMOSIS) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - NEUROLOGICAL - MAJOR (E.G. CVA) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - NEUROLOGICAL - MINOR (E.G. CVA) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - PERIPHERAL VASCULAR - MAJOR (E.G. NOSEBLEEDS; HEMATOMAS) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - PULMONARY/RESPIRATORY - MAJOR (E.G. HEMOTHORAX) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLEEDING - PULMONARY/RESPIRATORY - MINOR (E.G. HEMOTHORAX) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLOOD SEPSIS | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLOOD/LYMPHATIC - OTHER | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| THROMBOCYTOPENIA - HEPARIN INDUCED (HIT) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| THROMBOCYTOPENIA - NON-HEPARIN INDUCED | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| ANGINA, STABLE | Cardiac disorders | Systematic Assessment |
| ||
| ANGINA, UNSTABLE | Cardiac disorders | Systematic Assessment |
| ||
| AORTIC DISSECTION | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - ATRIAL FLUTTER | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - AV BLOCK - 1ST DEGREE | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - AV BLOCK - 2ND DEGREE | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - AV BLOCK - 3RD DEGREE | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - BRADYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - OTHER | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - PACEMAKER/ICD MALFUNCTION | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF) | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - PAROXYSMAL ATRIAL TACHYCARDIA (PAT) | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - PERSISTENT ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT) | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - TACHY-BRADYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - TACHYCARDIA - VENTRICULAR | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - VENTRICULAR FIBRILLATION | Cardiac disorders | Systematic Assessment |
| ||
| CARDIAC ARREST | Cardiac disorders | Systematic Assessment |
| ||
| CARDIAC DECOMPENSATION | Cardiac disorders | Systematic Assessment |
| ||
| CARDIOGENIC SHOCK | Cardiac disorders | Systematic Assessment |
| ||
| CARDIOVASCULAR - OTHER | Cardiac disorders | Systematic Assessment |
| ||
| CORONARY ARTERY OSTIAL OBSTRUCTION | Cardiac disorders | Systematic Assessment |
| ||
| ENDOCARDITIS | Cardiac disorders | Systematic Assessment |
| ||
| HEART FAILURE - ACUTE | Cardiac disorders | Systematic Assessment |
| ||
| HEART FAILURE - CHRONIC (CHF) | Cardiac disorders | Systematic Assessment |
| ||
| HYPERTENSION - SYSTEMIC | Cardiac disorders | Systematic Assessment |
| ||
| HYPOTENSION | Cardiac disorders | Systematic Assessment |
| ||
| MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
| ||
| PERFORATION - VENTRICULAR | Cardiac disorders | Systematic Assessment |
| ||
| PERICARDIAL EFFUSION - MAJOR | Cardiac disorders | Systematic Assessment |
| ||
| PERICARDIAL EFFUSION - MINOR | Cardiac disorders | Systematic Assessment |
| ||
| PERICARDIAL TAMPONADE | Cardiac disorders | Systematic Assessment |
| ||
| PERICARDITIS | Cardiac disorders | Systematic Assessment |
| ||
| REGURGITATION - AORTIC-CENTRAL/TRANSVALVULAR +4 | Cardiac disorders | Systematic Assessment |
| ||
| REGURGITATION - MITRAL-CENTRAL/TRANSVALVULAR +3 | Cardiac disorders | Systematic Assessment |
| ||
| REGURGITATION - MITRAL-CENTRAL/TRANSVALVULAR +4 | Cardiac disorders | Systematic Assessment |
| ||
| REGURGITATION - MITRAL-INDETERMINATE +3 | Cardiac disorders | Systematic Assessment |
| ||
| REGURGITATION - MITRAL-INDETERMINATE +4 | Cardiac disorders | Systematic Assessment |
| ||
| REGURGITATION - TRICUSPID-CENTRAL/TRANSVALVULAR +3 | Cardiac disorders | Systematic Assessment |
| ||
| REGURGITATION - TRICUSPID-CENTRAL/TRANSVALVULAR +4 | Cardiac disorders | Systematic Assessment |
| ||
| REGURGITATION - TRICUSPID-INDETERMINATE +3 | Cardiac disorders | Systematic Assessment |
| ||
| REGURGITATION - TRICUSPID-INDETERMINATE +4 | Cardiac disorders | Systematic Assessment |
| ||
| STENOSIS - MITRAL - SEVERE | Cardiac disorders | Systematic Assessment |
| ||
| THROMBOEMBOLIC EVENT - OTHER - CENTRAL - NO PARESIS | Cardiac disorders | Systematic Assessment |
| ||
| THROMBOEMBOLIC EVENT - STROKE | Cardiac disorders | Systematic Assessment |
| ||
| THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA) | Cardiac disorders | Systematic Assessment |
| ||
| VALVE THROMBOSIS - AORTIC | Cardiac disorders | Systematic Assessment |
| ||
| HEARING DISORDER | Ear and labyrinth disorders | Systematic Assessment |
| ||
| ENDOCRINE COMPLICATIONS | Endocrine disorders | Systematic Assessment |
| ||
| PANCREATIC COMPLICATION | Endocrine disorders | Systematic Assessment |
| ||
| VISION DISORDER | Eye disorders | Systematic Assessment |
| ||
| GASTROINTESTINAL - INFECTION | Gastrointestinal disorders | Systematic Assessment |
| ||
| GASTROINTESTINAL - OTHER | Gastrointestinal disorders | Systematic Assessment |
| ||
| ALLERGIC REACTION - MEDICATION RELATED | General disorders | Systematic Assessment |
| ||
| ALLERGIC REACTION - OTHER | General disorders | Systematic Assessment |
| ||
| ANAPHYLACTIC REACTION | General disorders | Systematic Assessment |
| ||
| CANCER - NEWLY DIAGNOSED | General disorders | Systematic Assessment |
| ||
| CANCER - PROGRESSION OF UNDERLYING DISEASE | General disorders | Systematic Assessment |
| ||
| FEVER - UNKNOWN ORIGIN | General disorders | Systematic Assessment |
| ||
| MULTI-SYSTEM ORGAN FAILURE | General disorders | Systematic Assessment |
| ||
| NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION | General disorders | Systematic Assessment |
| ||
| NSD - PARAVALVULAR LEAK +2 | General disorders | Systematic Assessment |
| ||
| NSD - PARAVALVULAR LEAK +3 | General disorders | Systematic Assessment |
| ||
| NSD - PARAVALVULAR LEAK +4 | General disorders | Systematic Assessment |
| ||
| NSD - PARAVALVULAR LEAK WITH HEMOLYSIS | General disorders | Systematic Assessment |
| ||
| NSD - STUDY VALVE STENOSIS - SEVERE | General disorders | Systematic Assessment |
| ||
| SPEECH DISORDER | General disorders | Systematic Assessment |
| ||
| SVD - STUDY VALVE CALCIFICATION | General disorders | Systematic Assessment |
| ||
| BILIARY (GALLBLADDER) | Hepatobiliary disorders | Systematic Assessment |
| ||
| HEPATIC COMPLICATION - OTHER | Hepatobiliary disorders | Systematic Assessment |
| ||
| LIVER FAILURE - ACUTE | Hepatobiliary disorders | Systematic Assessment |
| ||
| INFECTION/INFLAMMATION - OTHER | Infections and infestations | Systematic Assessment |
| ||
| STERNAL WOUND/THORACIC INFECTION | Infections and infestations | Systematic Assessment |
| ||
| WOUND INFECTION - OTHER | Infections and infestations | Systematic Assessment |
| ||
| METABOLIC COMPLICATIONS | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| BONE FRACTURE/BREAK | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| MUSCULAR SKELETAL/DERMATOLOGIC - OTHER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PSYCHIATRIC - OTHER | Psychiatric disorders | Systematic Assessment |
| ||
| PSYCHIATRIC DISORDER | Psychiatric disorders | Systematic Assessment |
| ||
| SUICIDE | Psychiatric disorders | Systematic Assessment |
| ||
| GENITOURINARY - OTHER | Renal and urinary disorders | Systematic Assessment |
| ||
| RENAL - OTHER | Renal and urinary disorders | Systematic Assessment |
| ||
| RENAL DYSFUNCTION | Renal and urinary disorders | Systematic Assessment |
| ||
| RENAL FAILURE - ACUTE | Renal and urinary disorders | Systematic Assessment |
| ||
| RENAL FAILURE - CHRONIC | Renal and urinary disorders | Systematic Assessment |
| ||
| URINARY TRACT INFECTION (UTI) | Renal and urinary disorders | Systematic Assessment |
| ||
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| HYPOXEMIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PLEURAL EFFUSION - BILATERAL | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PLEURAL EFFUSION - LEFT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PLEURAL EFFUSION - RIGHT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY EDEMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY EMBOLISM - BILATERAL | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY EMBOLISM - LEFT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY EMBOLISM - RIGHT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY/RESPIRATORY - OTHER | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY DYSFUNCTION/INSUFFICIENCY | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY FAILURE - ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY FAILURE - ASTHMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY FAILURE - COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY FAILURE - EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY FAILURE - HEMOTHORAX | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY FAILURE - OTHER | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY FAILURE - PNEUMONIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY FAILURE - PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY INFECTION - PNEUMONIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY INFECTION - UPPER (URI) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| VASCULAR - ACCESS SITE COMPLICATION | Vascular disorders | Systematic Assessment |
| ||
| VASCULAR - DEEP VEIN THROMBOSIS (DVT) | Vascular disorders | Systematic Assessment |
| ||
| VASCULAR - OTHER | Vascular disorders | Systematic Assessment |
| ||
| PERFORATION - OTHER | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| THROMBOCYTOPENIA - NON-HEPARIN INDUCED | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BLOOD/LYMPHATIC - OTHER | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| ANEMIA - BLEEDING RELATED - MINOR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| ANEMIA - NON-BLEEDING RELATED | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF) | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - AV BLOCK - 1ST DEGREE | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - OTHER | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - BRADYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT | Cardiac disorders | Systematic Assessment |
| ||
| HYPOTENSION | Cardiac disorders | Systematic Assessment |
| ||
| CARDIOVASCULAR - OTHER | Cardiac disorders | Systematic Assessment |
| ||
| HYPERTENSION - SYSTEMIC | Cardiac disorders | Systematic Assessment |
| ||
| GASTROINTESTINAL - OTHER | Gastrointestinal disorders | Systematic Assessment |
| ||
| URINARY TRACT INFECTION (UTI) | Renal and urinary disorders | Systematic Assessment |
| ||
| MUSCULAR SKELETAL/DERMATOLOGIC - OTHER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION | General disorders | Systematic Assessment |
| ||
| PSYCHIATRIC - OTHER | Psychiatric disorders | Systematic Assessment |
| ||
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PLEURAL EFFUSION - BILATERAL | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| ENDOCRINE COMPLICATIONS | Endocrine disorders | Systematic Assessment |
| ||
| RENAL DYSFUNCTION | Renal and urinary disorders | Systematic Assessment |
| ||
| RENAL - OTHER | Renal and urinary disorders | Systematic Assessment |
| ||
| RENAL FAILURE - ACUTE | Renal and urinary disorders | Systematic Assessment |
| ||
| INFECTION/INFLAMMATION - OTHER | Infections and infestations | Systematic Assessment |
| ||
| BONE FRACTURE/BREAK | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| VASCULAR - OTHER | Vascular disorders | Systematic Assessment |
| ||
| PULMONARY/RESPIRATORY - OTHER | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RESPIRATORY INFECTION - UPPER (URI) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| THROMBOCYTOPENIA - HEPARIN INDUCED (HIT) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - ATRIAL FLUTTER | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - PERSISTENT ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
| ||
| ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR | Cardiac disorders | Systematic Assessment |
| ||
| HEART FAILURE - ACUTE | Cardiac disorders | Systematic Assessment |
| ||
| PERICARDITIS | Cardiac disorders | Systematic Assessment |
| ||
| GENITOURINARY - OTHER | Renal and urinary disorders | Systematic Assessment |
| ||
| VISION DISORDER | Eye disorders | Systematic Assessment |
|
PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation, but data analyses of site-specific results can occur only in intervals as specified in the CTA. Publication/presentation of the PI's site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Currin, Senior VP of Medical and Clinical Affairs, Surgical Structural Heart | Edwards Lifesciences, LLC | 949-250-2500 | Jennifer_Currin@edwards.com |
| Mar 3, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Study valve explant |
|
| Thromboembolism |
|
| Valve thrombosis |
|
| Endocarditis |
|
| All bleeding |
|
| Major bleeding |
|
| All paravalvular leak |
|
| Major paravalvular leak (PVL) |
|
| Hemolysis |
|
| Non-structural valve dysfunction other than PVL |
|
| Valve migration/embolization |
|
| Valve malposition |
|
| Valve instability |
|
| Valve dislodgement |
|
| Valve stenosis |
|
| Structural valve deterioration |
|
| Conduction defects |
|
| Conduction defects with permanent pacemaker |
|
| Conduction defects without permanent pacemaker |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| OG002 |
| Edwards INTUITY Surgical Aortic Heart Valve - Class III |
Subjects who received an INTUITY study surgical aortic heart valve. |
| OG003 | Edwards INTUITY Surgical Aortic Heart Valve - Class IV | Subjects who received an INTUITY study surgical aortic heart valve. |
|
|
| OG003 |
| Edwards INTUITY Surgical Aortic Heart Valve - 25mm |
Subjects who received an INTUITY study surgical aortic heart valve. |
| OG004 | Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subjects who received an INTUITY study surgical aortic heart valve. |
|
|
| OG003 |
| Edwards INTUITY Surgical Aortic Heart Valve - 25mm |
Subjects who received an INTUITY study surgical aortic heart valve. |
| OG004 | Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subjects who received an INTUITY study surgical aortic heart valve. |
|
|
| OG003 | Edwards INTUITY Surgical Aortic Heart Valve - 25mm | Subjects who received an INTUITY study surgical aortic heart valve. |
| OG004 | Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subjects who received an INTUITY study surgical aortic heart valve. |
|
|
| OG003 | Edwards INTUITY Surgical Aortic Heart Valve - 25mm | Subjects who received an INTUITY study surgical aortic heart valve. |
| OG004 | Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subjects who received an INTUITY study surgical aortic heart valve. |
|
|
Subjects who received an INTUITY study surgical aortic heart valve.
| OG003 | Edwards INTUITY Surgical Aortic Heart Valve - 25mm | Subjects who received an INTUITY study surgical aortic heart valve. |
| OG004 | Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subjects who received an INTUITY study surgical aortic heart valve |
|
|
| OG003 | Edwards INTUITY Surgical Aortic Heart Valve - 25mm | Subjects who received an INTUITY study surgical aortic heart valve. |
| OG004 | Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subjects who received an INTUITY study surgical aortic heart valve. |
|
|
| OG002 |
| Edwards INTUITY Surgical Aortic Heart Valve - 23mm |
Subjects who received an INTUITY study surgical aortic heart valve. |
| OG003 | Edwards INTUITY Surgical Aortic Heart Valve - 25mm | Subjects who received an INTUITY study surgical aortic heart valve. |
| OG004 | Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subjects who received an INTUITY study surgical aortic heart valve. |
|
|
| OG003 | Edwards INTUITY Surgical Aortic Heart Valve - 25mm | Subjects who received an INTUITY study surgical aortic heart valve |
| OG004 | Edwards INTUITY Surgical Aortic Heart Valve - 27mm | Subjects who received an INTUITY study surgical aortic heart valve |
|
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| Title | Measurements |
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| Mild (+2) |
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| Moderate (+3) |
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| Severe (+4) |
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