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The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
This is a randomized study to compare the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system in a minimally invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach, in patients with logistic EuroScore < 20 undergoing elective isolated aortic valve replacement (AVR) surgery.
Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and to explore additional healthcare resource utilization endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDWARDS INTUITY | Active Comparator | EDWARDS INTUITY Valve System, Model 8300A |
|
| Stented Aortic Bioprostheses | Active Comparator | Stented Aortic Bioprostheses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDWARDS INTUITY Valve System, Model 8300A | Device | To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing MIS-AVR. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Subject Time Spent on Cardiopulmonary Cross Clamp | Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level. | At time of surgery; an average of 1 hour |
| Median Amount of Time Subject Spent on Cardiopulmonary Bypass | Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery. | At time of surgery; an average of 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. | 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. |
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Inclusion:
Exclusion (i.a.):
pure aortic insufficiency
previous cardiac surgery (involved FS or MIS approach)
congenital true bicuspid / unicuspid aortic valve
requires emergency surgery or has had emergency surgery for any reason
≤ 1 month before the intended treatment
LVEF <25%
active endocarditis ≤ 6 months before the intended treatment
acute MI ≤ 90 days before the intended treatment
had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery
oxygen or ventilator dependent
life expectancy < 12 months
substance abuser
Female subject is pregnant or lactating
documented leukopenia (WBC < 3.5x 103/μL), acute anemia (Hgb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy
hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
documented echocardiographic evidence of intracardiac mass, thrombus or vegetation
renal insufficiency as determined by Serum creatinine ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis
documented hyperparathyroidism
currently participating in an investigational drug or device trial for which follow-up has not yet been completed
Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition
Intra-operative Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Borger, MD | Leipzig Heart Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leipzig Heart Center | Leipzig | Saxony | 04289 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26935407 | Result | Borger MA, Dohmen PM, Knosalla C, Hammerschmidt R, Merk DR, Richter M, Doenst T, Conradi L, Treede H, Moustafine V, Holzhey DM, Duhay F, Strauch J. Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial. Eur J Cardiothorac Surg. 2016 Oct;50(4):713-720. doi: 10.1093/ejcts/ezw042. Epub 2016 Mar 2. | |
| 25441065 |
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As of this date no IPD plan has been formulated.
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Three (3) of the subjects randomized to the Edwards INTUITY group were converted to the control group and received a commercially available surgical aortic heart valve via MIS and therefore these three (3) subjects could not be accurately categorized into the MIS-AVR or FS-AVR category and were excluded from the as intended (AI) cohort.
All eligible subjects recruited were randomized to each arm/group as 1:1 ratio at start.
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| ID | Title | Description |
|---|---|---|
| FG000 | Edwards INTUITY Surgical Aortic Heart Valve | Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR |
| FG001 | Control Group - Commercial Surgical Aortic Heart Valve | Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
3 of the subjs. randomized to the Edwards INTUITY group were converted to the control group and rec'd commercially available surgical aortic heart valves.From the overall,2 randomized to Edwards INTUITY &1 randomized to control group were screen failures prior to procedure & were excluded in the baseline analysis.Analysis is based on the AI cohort
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| ID | Title | Description |
|---|---|---|
| BG000 | Edwards INTUITY Surgical Aortic Heart Valve | Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR |
| BG001 | Control Group - Commercial Surgical Aortic Heart Valve |
| 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 | Median Subject Time Spent on Cardiopulmonary Cross Clamp | Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level. | The outcome is reported for subjects where data is available. Analysis is based on the AI cohort | Posted | Median | Full Range | Minutes | At time of surgery; an average of 1 hour |
|
Events occurring from baseline through two (2) years post implant
Adverse event table is reported using ITT cohort
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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 | Edwards INTUITY Surgical Aortic Heart Valve | Subject who received an Edwards INTUITY surgical aortic heart valve undergoing MIS-AVR |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BLEEDING - CARDIOVASCULAR - MAJOR | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF) | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Edwards, VP Clinical and Regulatory Affairs, HVT | Edwards Lifesciences, LLC | 949-250-2500 | 1536 | mary_edwards@edwards.com |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Stented Aortic Bioprostheses | Device | In comparison to control valves available on the market undergoing FS-AVR |
|
|
| Baseline and 2 Years. |
| Subject's Average Mean Gradients (mmHg) 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. Mean gradient values depend on the size and type of valve. | Baseline, Discharge, 30 days, 3 Months, 1 Year |
| Subject's Average Peak Gradients (mmHg) 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. | Baseline, Discharge, 30 days, 3 Months, 1 Year |
| 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. | Baseline, Discharge, 30 days, 3 Months, 1 Year |
| Amount of Paravalvular Leak Over Time. | Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. | Discharge, 30 days, 3 month, 1 year |
| Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery. | Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery. | Prior to Surgery |
| Subjects Who Required a Thoracic Resternotomy Over Time | Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects Who Received a Permanent Pacemaker Over Time. | Number of Subjects who received a Permanent Pacemaker shown over various time points. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time | Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects Who Experienced Major Bleeding Over Time. | Number of subjects who experienced Major Bleeding shown over various time points. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects Who Experienced Respiratory Failure Over Time | Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects With Renal Failure Over Time | Number of subjects who experienced Renal (kidney) Failure shown over various time points. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects With Endocarditis Over Time | Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects With a Deep Sternal Would Infection Over Time | Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects With a Myocardial Infarction Over Time | Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects With a Thromboembolism Over Time | Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects With a Cardiac Tamponade Over Time | Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart. | 30 days, 3 Months, 1 Year, 2 Years. |
| Subjects With a Cardiac Reoperation for Any Reason Over Time | Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points. | 30 days, 3 Months, 1 Year, 2 Years. |
| Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery. | Subjects Randomized to Edwards INTUITY Group's Surgical Aortic Valve undergoing Minimally Invasive Surgical incision being converted to a Full Sternotomy open procedure During Surgery. | Prior to Surgery |
| Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time | The EuroQol-5 Dimension (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. | Baseline, 30 days, 3 Months, 1 Year |
| Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12. The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status. | Baseline, 30 days, 3 Months, 1 Year |
| Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at Baseline, 30 days, 3 Months,and 1 Year. | Baseline, 30 days, 3 Months, 1 Year |
| Health Care Utilization | The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure. | Day of surgical procedure through discharge from the hospital, an average of 1.5 weeks |
| 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 aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. | Baseline, Discharge, 30 days, 3 Months, 1 Year |
| Amount of Aortic Valvular Regurgitation Over Time. | Aortic valvular regurgitation occurs when the aortic 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. Aortic 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, 30 days, 3 month, 1 year |
| Result |
| Borger MA, Moustafine V, Conradi L, Knosalla C, Richter M, Merk DR, Doenst T, Hammerschmidt R, Treede H, Dohmen P, Strauch JT. A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement. Ann Thorac Surg. 2015 Jan;99(1):17-25. doi: 10.1016/j.athoracsur.2014.09.022. Epub 2014 Nov 20. |
| Conversion to Commercial Valve |
|
| Withdrawal by Subject |
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| Intraoperative screen failure |
|
Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR |
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| Primary | Median Amount of Time Subject Spent on Cardiopulmonary Bypass | Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery. | The outcome is reported for subjects where data is available. Analysis is based on the AI cohort | Posted | Median | Full Range | Minutes | At time of surgery; an average of 1 hour |
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| Secondary | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. | 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. | The outcome is reported for subjects where data is available. Analysis is based on the ITT cohort | Posted | Count of Participants | Participants | Baseline and 2 Years. |
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|
| Secondary | Subject's Average Mean Gradients (mmHg) 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. Mean gradient values depend on the size and type of valve. | The outcome is reported for subjects where data is available. Analysis is based on the AI cohort | Posted | Mean | Standard Deviation | mmHg | Baseline, Discharge, 30 days, 3 Months, 1 Year |
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|
| Secondary | Subject's Average Peak Gradients (mmHg) 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. | The outcome is reported for subjects where data is available. Analysis is based on the AI cohort | Posted | Mean | Standard Deviation | mmHg | Baseline, Discharge, 30 days, 3 Months, 1 Year |
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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. | The outcome is reported for subjects where data is available. Analysis is based on the AI cohort | Posted | Mean | Standard Deviation | centimeters squared | Baseline, Discharge, 30 days, 3 Months, 1 Year |
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| Secondary | Amount of Paravalvular Leak Over Time. | Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. | The outcome is reported for subjects where data is available. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | Discharge, 30 days, 3 month, 1 year |
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| Secondary | Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery. | Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery. | Analysis is based on the ITT cohort | Posted | Count of Participants | Participants | No | Prior to Surgery |
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|
| Secondary | Subjects Who Required a Thoracic Resternotomy Over Time | Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points. | Cumulative number of subjects with an event by each time point Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects Who Received a Permanent Pacemaker Over Time. | Number of Subjects who received a Permanent Pacemaker shown over various time points. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time | Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects Who Experienced Major Bleeding Over Time. | Number of subjects who experienced Major Bleeding shown over various time points. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects Who Experienced Respiratory Failure Over Time | Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time | Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects With Renal Failure Over Time | Number of subjects who experienced Renal (kidney) Failure shown over various time points. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects With Endocarditis Over Time | Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects With a Deep Sternal Would Infection Over Time | Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects With a Myocardial Infarction Over Time | Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects With a Thromboembolism Over Time | Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects With a Cardiac Tamponade Over Time | Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Subjects With a Cardiac Reoperation for Any Reason Over Time | Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points. | Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | 30 days, 3 Months, 1 Year, 2 Years. |
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| Secondary | Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery. | Subjects Randomized to Edwards INTUITY Group's Surgical Aortic Valve undergoing Minimally Invasive Surgical incision being converted to a Full Sternotomy open procedure During Surgery. | Analysis is based on the ITT cohort | Posted | Count of Participants | Participants | No | Prior to Surgery |
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| Secondary | Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time | The EuroQol-5 Dimension (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. | The outcome is reported where data is available. Analysis is based on the ITT cohort | Posted | Mean | Standard Deviation | units on a scale | Baseline, 30 days, 3 Months, 1 Year |
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| Secondary | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time | Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12. The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status. | The outcome is reported where data is available. Analysis is based on the ITT cohort | Posted | Mean | Standard Deviation | units on a scale | Baseline, 30 days, 3 Months, 1 Year |
|
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| Secondary | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at Baseline, 30 days, 3 Months,and 1 Year. | The outcome is reported where data is available. Analysis is based on the ITT cohort | Posted | Mean | Standard Deviation | units on a scale | Baseline, 30 days, 3 Months, 1 Year |
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| Secondary | Health Care Utilization | The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure. | This outcome is reported for subjects where data is available. Analysis is based on the ITT cohort | Posted | Mean | Standard Deviation | Days | Day of surgical procedure through discharge from the hospital, an average of 1.5 weeks |
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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 aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. | The outcome is reported for subjects where data is available. Analysis is based on the AI cohort | Posted | Mean | Standard Deviation | centimeters squared/meters squared | Baseline, Discharge, 30 days, 3 Months, 1 Year |
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| Secondary | Amount of Aortic Valvular Regurgitation Over Time. | Aortic valvular regurgitation occurs when the aortic 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. Aortic 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. | The outcome is reported for subjects where data is available. Analysis is based on the AI cohort | Posted | Count of Participants | Participants | Discharge, 30 days, 3 month, 1 year |
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| 4 |
| 49 |
| 31 |
| 49 |
| 27 |
| 49 |
| EG001 | Control Group - Commercial Surgical Aortic Heart Valve | Subject who received a commercially available surgical aortic heart valve undergoing FS-AVR | 4 | 48 | 27 | 48 | 30 | 48 |
| BLEEDING - GASTROINTESTINAL UPPER -MAJOR | Blood and lymphatic system disorders | Systematic Assessment |
|
| BLEEDING - NEUROLOGICAL - MAJOR (E.G. CVA) | Blood and lymphatic system disorders | Systematic Assessment |
|
| BLEEDING - PERIPHERAL VASCULAR - MINOR (E.G. NOSEBLEEDS; HEMATOMAS) | Blood and lymphatic system 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 |
|
| ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF) | Cardiac disorders | Systematic Assessment |
|
| ARRHYTHMIA - AV BLOCK - 3RD DEGREE | Cardiac disorders | Systematic Assessment |
|
| ARRHYTHMIA - BRADYCARDIA | Cardiac disorders | Systematic Assessment |
|
| ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
|
| ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT) | Cardiac disorders | Systematic Assessment |
|
| ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR | Cardiac disorders | Systematic Assessment |
|
| ARRHYTHMIA - TACHYCARDIA - VENTRICULAR | Cardiac disorders | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
|
| PERICARDIAL EFFUSION - MAJOR | Cardiac disorders | Systematic Assessment |
|
| PERICARDIAL TAMPONADE - MAJOR | Cardiac disorders | Systematic Assessment |
|
| CARDIAC DECOMPENSATION | Cardiac disorders | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | Systematic Assessment |
|
| CARDIOVASCULAR - OTHER | Cardiac disorders | Systematic Assessment |
|
| CARDIOGENIC SHOCK | Cardiac disorders | Systematic Assessment |
|
| ENDOCARDITIS | Cardiac disorders | Systematic Assessment |
|
| PERICARDITIS | Cardiac disorders | Systematic Assessment |
|
| REGURGITATION - MITRAL-INDETERMINATE-+4 | Cardiac disorders | Systematic Assessment |
|
| NSD - PARAVALVULAR LEAK - +4 | General disorders | Systematic Assessment |
|
| NSD - PARAVALVULAR LEAK WITH HEMOLYSIS | General disorders | Systematic Assessment |
|
| BILIARY (GALLBLADDER) | Gastrointestinal disorders | Systematic Assessment |
|
| GASTROINTESTINAL - OTHER | Gastrointestinal disorders | Systematic Assessment |
|
| GASTROINTESTINAL - INFECTION | Gastrointestinal disorders | Systematic Assessment |
|
| GENITOURINARY - 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 - OTHER | Renal and urinary disorders | Systematic Assessment |
|
| URINARY TRACT INFECTION (UTI) | Renal and urinary disorders | Systematic Assessment |
|
| MUSCULAR SKELETAL / DERMATOLOGIC - OTHER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| STERNAL WOUND/THORACIC INFECTION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| INFECTION /INFLAMMATION - OTHER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| CANCER - NEWLY DIAGNOSED | General disorders | Systematic Assessment |
|
| NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION | General disorders | Systematic Assessment |
|
| ALLERGIC REACTION - MEDICATION RELATED | General disorders | Systematic Assessment |
|
| MULTI-SYSTEM ORGAN FAILURE | General disorders | Systematic Assessment |
|
| VASCULAR - OTHER | Vascular disorders | Systematic Assessment |
|
| TRANSIENT PSYCHOTIC SYNDROME | Psychiatric disorders | Systematic Assessment |
|
| PLEURAL EFFUSION - BILATERAL | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RESPIRATORY INFECTION - PNEUMONIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RESPIRATORY FAILURE -PNEUMONIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PLEURAL EFFUSION - LEFT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RESPIRATORY FAILURE -COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
|
| PERICARDIAL EFFUSION - MINOR | Cardiac disorders | Systematic Assessment |
|
| GASTROINTESTINAL - OTHER | Gastrointestinal disorders | Systematic Assessment |
|
| MUSCULAR SKELETAL / DERMATOLOGIC - OTHER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| PLEURAL EFFUSION - BILATERAL | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ANEMIA - NON-BLEEDING RELATED | Blood and lymphatic system disorders | Systematic Assessment |
|
| ANEMIA - BLEEDING RELATED - MINOR | Blood and lymphatic system disorders | Systematic Assessment |
|
| BLEEDING - GASTROINTESTINAL LOWER -MINOR | Blood and lymphatic system disorders | Systematic Assessment |
|
| BLEEDING - PULMONARY/RESPIRATORY MINOR (E.G. HEMOTHORAX) | Blood and lymphatic system disorders | Systematic Assessment |
|
| BLOOD/ LYMPHATIC - OTHER | Blood and lymphatic system disorders | Systematic Assessment |
|
| THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA) | 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 - PAROXYSMAL ATRIAL TACHYCARDIA (PAT) | Cardiac disorders | Systematic Assessment |
|
| ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT) | Cardiac disorders | Systematic Assessment |
|
| ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
|
| ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR | Cardiac disorders | Systematic Assessment |
|
| CARDIOVASCULAR - OTHER | Cardiac disorders | Systematic Assessment |
|
| NSD - PARAVALVULAR LEAK - +1 | General disorders | Systematic Assessment |
|
| GASTROINTESTINAL - INFECTION | Gastrointestinal disorders | Systematic Assessment |
|
| RENAL FAILURE - ACUTE | Renal and urinary disorders | Systematic Assessment |
|
| GENITOURINARY - OTHER | Renal and urinary disorders | Systematic Assessment |
|
| URINARY TRACT INFECTION (UTI) | Renal and urinary disorders | Systematic Assessment |
|
| WOUND INFECTION - OTHER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| INFECTION /INFLAMMATION - OTHER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION | General disorders | Systematic Assessment |
|
| TRANSIENT PSYCHOTIC SYNDROME | Psychiatric disorders | Systematic Assessment |
|
| PLEURAL EFFUSION - LEFT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PLEURAL EFFUSION - RIGHT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PULMONARY/RESPIRATORY - OTHER | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RESPIRATORY FAILURE -COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RESPIRATORY INFECTION - PNEUMONIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RESPIRATORY FAILURE -OTHER | Respiratory, thoracic and mediastinal 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.
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
| Worsened |
|
| Discharge |
|
|
| 30 days |
|
|
| 3 months |
|
|
| 1 year |
|
|
| Discharge |
|
|
| 30 days |
|
|
| 3 months |
|
|
| 1 year |
|
|
| Discharge |
|
|
| 30 days |
|
|
| 3 months |
|
|
| 1 year |
|
|
| +1 Trivial/Trace |
|
| +2 Mild |
|
| +3 Moderate |
|
| +4 Severe |
|
| 30 days |
|
|
| 3 months |
|
|
| 1 year |
|
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 1 year |
|
| 2 year |
|
| 30 day |
|
|
| 3 month |
|
|
| 1 year |
|
|
| PCS - 30 day |
|
|
| PCS - 3 month |
|
|
| PCS - 1 year |
|
|
| MCS - Baseline |
|
|
| MCS - 30 day |
|
|
| MCS - 3 month |
|
|
| MCS - 1 year |
|
|
| 30 day |
|
|
| 3 month |
|
|
| 1 year |
|
|
| ICU Length of stay |
|
|
| Intermediate Care Length of stay |
|
|
| Discharge |
|
|
| 30 days |
|
|
| 3 months |
|
|
| 1 year |
|
|
| +1 Trivial/Trace |
|
| +2 Mild |
|
| +3 Moderate |
|
| +4 Severe |
|
| 30 days |
|
|
| 3 months |
|
|
| 1 year |
|
|