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The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for surgical operation.
The purpose of this trial is to evaluate the effectiveness and safety of the MDT-2111 TAV system in subjects with small annuli and symptomatic severe AS deemed difficult for surgical intervention. The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 New York Heart Association (NYHA) class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDT-2111 TAVI 23 mm | Experimental | Subjects with small annuli and symptomatic severe AS deemed difficult for surgical intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDT-2111 TAVI 23 mm | Device | Device: 23 mm MDT-2111 System for Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Score of Change in New York Heart Association (NYHA) Class and Effective Orifice Area (EOA). | The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 NYHA class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months. | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| New York Heart Classification (NYHA) Over Time | NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity. Class II: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. |
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Inclusion Criteria:
Subject must have co-morbidities such that one cardiologist and one cardiac surgeon agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement.
Subject has senile degenerative aortic valve stenosis with:
mean gradient > 40 mmHg or jet velocity greater than 4.0 m/s by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND an initial aortic valve area of ≤ 0.8 cm² (or aortic valve area index ≤ 0.5 cm²/m²) by resting echocardiogram.
Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class Class III or greater. If screening committee agrees the eligibility of a patient with class II , based on medical factors, he/she can be enrolled.
Patient has been informed of the nature of the trial and has signed an Informed Consent Form.
Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.
Exclusion Criteria:
Evidence of an acute myocardial infarction ≤ 30 days prior to the intended treatment.
Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the procedure.
Blood dyscrasias as defined:
Untreated clinically significant coronary artery disease requiring revascularization.
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
Need for emergency surgery for any reason.
Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as measured by resting echocardiogram.
Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack(TIA).
End stage renal disease requiring chronic dialysis.
GI bleeding within the past 3 months.
A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
Ongoing sepsis, including active endocarditis.
Subject refuses a blood transfusion.
Life expectancy < 12 months due to associated non-cardiac co-morbid conditions.
Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
Currently participating in an investigational drug or another device trial. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
Symptomatic carotid or vertebral artery disease.
Native aortic annulus size < 18 mm or > 20 mm per the screening diagnostic imaging.
Pre-existing prosthetic heart valve in any position.
Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation).
Mitral regurgitation (moderate to severe) or severe tricuspid regurgitation.
Moderate to severe mitral stenosis.
Hypertrophic obstructive cardiomyopathy.
Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
Severe basal septal hypertrophy with an outflow gradient.
Ascending aorta diameter > 34 mm
Congenital bicuspid or unicuspid valve verified by echocardiography.
For patients with native coronary artery dependent circulation:
Femoral or iliac artery of the first choice corresponding to any one of the following:
Subclavian artery of the second choice corresponding to any one of the following:
Direct Aortic Artery as third line choice of access. Patients are excluded from Direct Aortic access if:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshi Sawa, Professor | Osaka University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shonan Kamakura General Hospital | Kamakura | Kanagawa | Japan | |||
| National Cerebral and Cardiovascular Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28321003 | Derived | Sawa Y, Torikai K, Kobayashi J, Niinami H, Kuratani T, Maeda K, Kanzaki H, Komiyama N, Tanaka Y, Zhang A, Saito S. Midterm Outcomes With a Self-Expandable Transcatheter Heart Valve in Japanese Patients With Symptomatic Severe Aortic Stenosis. Circ J. 2017 Jul 25;81(8):1108-1115. doi: 10.1253/circj.CJ-17-0112. Epub 2017 Mar 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MDT-2111 TAVI 23 mm | Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MDT-2111 TAVI 23 mm | Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system. |
| 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 | Composite Score of Change in New York Heart Association (NYHA) Class and Effective Orifice Area (EOA). | The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 NYHA class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months. | Implanted subjects | Posted | Number | percentage of participants analyzed | baseline and 6 months |
|
Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
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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 | Iliofemoral (As Treated Subjects) | The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients implanted with Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic Valvular Disorders | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia Deficiencies | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hiroko Ookubo | Medttronic | 81367760811 | hiroko.ookubo@medtronic.com |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| 30 days |
| New York Heart Classification (NYHA) Over Time | NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity. Class II: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | 6 months |
| New York Heart Classification (NYHA) Over Time | NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity. Class II: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | 12 months |
| New York Heart Classification (NYHA) Over Time | NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity. Class II: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | 24 months |
| Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | MACCE is defined as a composite of:
| 0 day to 30 days |
| Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | MACCE is defined as a composite of:
| 0 day to 6 months |
| Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | MACCE is defined as a composite of:
| 0 day to 12 months |
| Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | MACCE is defined as a composite of:
| 0 day to 24 months |
| Device Success as Defined in the Description. | The following components must be satisfied for device success:
| after procedure or discharge |
| Procedural Success, Defined as Device Success and Absence of In-hospital MACCE | Procedural success is defined as device success and absence of in-hospital MACCE. | from admission for procedure to discharge |
| Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient | 30 days |
| Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient | 6 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient | 12 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient | 24 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA) | 30 days |
| Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA) | 6 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA) | 12 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA) | 24 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF) | 30 days |
| Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF) | 6 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF) | 12 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF) | 24 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) | 30 days |
| Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) | 6 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) | 12 months |
| Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) | 24 months |
| Repeat Hospitalization | 0 day to 30 days |
| Repeat Hospitalization | 0 day to 6 months |
| Repeat Hospitalization | 0 day to 12 months |
| Repeat Hospitalization | 0 day to 24 months |
| Valve-related Deaths | 0 day to 30 days |
| Valve-related Deaths | 0 day to 6 months |
| Valve-related Deaths | 0 day to 12 months |
| Valve-related Deaths | 0 day to 24 months |
| Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) | The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 Í Í« Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average. | Baseline to 30 days |
| Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) | The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 Í Í« Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average. | Baseline to 6 months |
| Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) | The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 Í Í« Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average. | Baseline to 12 months |
| Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) | The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 Í Í« Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average. | Baseline to 24 months |
| Suita |
| Osaka |
| Japan |
| Osaka University Hospital | Suita | Osaka | Japan |
| Saitama Medical University | Hidaka | Saitama | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NYHA Class | NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | Number | participants |
|
| STS Score | The Society of Thoracic Surgeons (STS) risk model predicts the risk of operative mortality and morbidity after adult cardiac surgery on the basis of patient demographic and clinical variables. After information has been entered on a given case, the online STS risk calculator provides a risk percentage for each of the outcomes. The risk percentage estimates the chance of a specific outcome for a patient with the indicated risk factors. A higher score indicates a higher risk. A lower score indicates a lower risk. | Mean | Standard Deviation | percent |
|
| Logistic EuroScore | The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a method of calculating predicted operative mortality for patients undergoing cardiac surgery. If a risk factor is present, a weight/number is assigned. The weights are added to give an approximate percent of predicted mortality. A higher score indicates a higher risk. A lower score indicates a lower risk. | Mean | Standard Deviation | percent |
|
| Body Surface Area | Mean | Standard Deviation | m² |
|
The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
|
|
|
| Secondary | New York Heart Classification (NYHA) Over Time | NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity. Class II: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | All Implanted Subjects | Posted | Number | percentage of participants analyzed | 30 days |
|
|
|
| Secondary | New York Heart Classification (NYHA) Over Time | NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity. Class II: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | All Implanted Subjects | Posted | Number | percentage of participants analyzed | 6 months |
|
|
|
| Secondary | New York Heart Classification (NYHA) Over Time | NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity. Class II: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | All Implanted Subjects | Posted | Number | percentage of participants analyzed | 12 months |
|
|
|
| Secondary | New York Heart Classification (NYHA) Over Time | NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity. Class II: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | All Implanted Subjects | Posted | Number | percentage of participants analyzed | 24 months |
|
|
|
| Secondary | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | MACCE is defined as a composite of:
| The Kaplan-Meier Method was used to calculate the number. | Posted | Number | prob of freedom from event @ 30 days | 0 day to 30 days |
|
|
|
| Secondary | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | MACCE is defined as a composite of:
| The Kaplan-Meier Method was used to calculate the number. | Posted | Number | prob of freedom from event @ 183 days | 0 day to 6 months |
|
|
|
| Secondary | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | MACCE is defined as a composite of:
| The Kaplan-Meier Method was used to calculate the number. | Posted | Number | prob of freedom from event @ 365 days | 0 day to 12 months |
|
|
|
| Secondary | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | MACCE is defined as a composite of:
| The Kaplan-Meier Method was used to calculate the number. | Posted | Number | prob of freedom from event @ 730 days | 0 day to 24 months |
|
|
|
| Secondary | Device Success as Defined in the Description. | The following components must be satisfied for device success:
| This includes subjects with an index procedure. Index procedure is defined as the first procedure that Medtronic MDT-2111 TAV system delivery catheter is introduced. | Posted | Number | percentage of participants analyzed | after procedure or discharge |
|
|
|
| Secondary | Procedural Success, Defined as Device Success and Absence of In-hospital MACCE | Procedural success is defined as device success and absence of in-hospital MACCE. | This includes subjects with an index procedure. Index procedure is defined as the first procedure that Medtronic MDT-2111 TAV system delivery catheter is introduced. | Posted | Number | percent | from admission for procedure to discharge |
|
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient | Posted | Mean | Standard Deviation | mmHg | 30 days |
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient | Posted | Mean | Standard Deviation | mmHg | 24 months |
|
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA) | Posted | Mean | Standard Deviation | cm² | 30 days |
|
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA) | Posted | Mean | Standard Deviation | cm² | 6 months |
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA) | Posted | Mean | Standard Deviation | cm² | 12 months |
|
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA) | Posted | Mean | Standard Deviation | cm² | 24 months |
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF) | Posted | Mean | Standard Deviation | percent | 30 days |
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF) | Posted | Mean | Standard Deviation | percent | 6 months |
|
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF) | Posted | Mean | Standard Deviation | percent | 12 months |
|
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF) | Posted | Mean | Standard Deviation | percent | 24 months |
|
|
|
| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) | Posted | Number | percentage of participants analyzed | 30 days |
|
|
|
| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) | Posted | Number | percentage of participants analyzed | 6 months |
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) | Posted | Number | percentage of participants analyzed | 12 months |
|
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| Secondary | Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) | Posted | Number | percentage of participants analyzed | 24 months |
|
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| Secondary | Repeat Hospitalization | Posted | Number | prob of freedom from event @ 30 days | 0 day to 30 days |
|
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| Secondary | Repeat Hospitalization | Posted | Number | prob of freedom from event @ 183 days | 0 day to 6 months |
|
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| Secondary | Repeat Hospitalization | Posted | Number | prob of freedom from event @ 365 days | 0 day to 12 months |
|
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| Secondary | Repeat Hospitalization | Posted | Number | prob of freedom from event @ 730 days | 0 day to 24 months |
|
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| Secondary | Valve-related Deaths | Posted | Number | prob of freedom from event @ 30 days | 0 day to 30 days |
|
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| Secondary | Valve-related Deaths | Posted | Number | prob of freedom from event @ 183 days | 0 day to 6 months |
|
|
|
| Secondary | Valve-related Deaths | Posted | Number | prob of freedom from event @ 365 days | 0 day to 12 months |
|
|
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| Secondary | Valve-related Deaths | Posted | Number | prob of freedom from event @ 730 days | 0 day to 24 months |
|
|
|
| Secondary | Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) | The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 Í Í« Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average. | Posted | Median | Inter-Quartile Range | points | Baseline to 30 days |
|
|
|
| Secondary | Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) | The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 Í Í« Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average. | Posted | Median | Inter-Quartile Range | points | Baseline to 6 months |
|
|
|
| Secondary | Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) | The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 Í Í« Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average. | Posted | Median | Inter-Quartile Range | points | Baseline to 12 months |
|
|
|
| Secondary | Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) | The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 Í Í« Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average. | Posted | Median | Inter-Quartile Range | points | Baseline to 24 months |
|
|
|
| 13 |
| 16 |
| 16 |
| 16 |
| EG001 | Direct Aortic (As Treated Subjects) | For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in overseas (EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system. | 3 | 4 | 4 | 4 |
| EG002 | All Subjects (As Treated Subjects) | This includes subjects from all access approaches, iliofemoral and direct aortic who were implanted with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system. | 16 | 20 | 20 | 20 |
| Cardiac Conduction Disorders | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cardiac Disorders Nec | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Heart Failures Nec | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pericardial Disorders Nec | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Supraventricular Arrhythmias | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Blindness (Excl Colour Blindness) | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cataract Conditions | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Non-Site Specific Gastrointestinal Haemorrhages | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Oesophageal Stenosis And Obstruction | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Device Issues Nec | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hepatic Fibrosis And Cirrhosis | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hepatocellular Damage And Hepatitis Nec | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cardiac Infections | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Influenza Viral Infections | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Lower Respiratory Tract And Lung Infections | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Sepsis, Bacteraemia, Viraemia And Fungaemia Nec | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Staphylococcal Infections | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Lower Limb Fractures And Dislocations | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Skull Fractures, Facial Bone Fractures And Dislocations | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Spinal Fractures And Dislocations | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Total Fluid Volume Decreased | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Arthropathies Nec | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Breast And Nipple Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Central Nervous System Haemorrhages And Cerebrovascular Accidents | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Breathing Abnormalities | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pneumothorax And Pleural Effusions Nec | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Aortic Necrosis And Vascular Insufficiency | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lymphangiopathies | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Non-Site Specific Necrosis And Vascular Insufficiency Nec | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Peripheral Embolism And Thrombosis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Anaemias Nec | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lymphatic System Disorders Nec | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cardiac Conduction Disorders | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Heart Failures Nec | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rate And Rhythm Disorders Nec | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Supraventricular Arrhythmias | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Ventricular Arrhythmias And Cardiac Arrest | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Diarrhoea (Excl Infective) | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastrointestinal And Abdominal Pains (Excl Oral And Throat) | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastrointestinal Atonic And Hypomotility Disorders Nec | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nausea And Vomiting Symptoms | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Administration Site Reactions Nec | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Complications Associated With Device Nec | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Device Physical Property And Chemical Issues | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Febrile Disorders | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Implant And Catheter Site Reactions | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Inflammations | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Infusion Site Reactions | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Oedema Nec | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pain And Discomfort Nec | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hepatic And Hepatobiliary Disorders Nec | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hepatic Enzymes And Function Abnormalities | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Herpes Viral Infections | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Infections Nec | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Influenza Viral Infections | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Urinary Tract Infections | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Fractures And Dislocations Nec | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Non-Site Specific Injuries Nec | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Non-Site Specific Procedural Complications | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Skin Injuries Nec | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Spinal Fractures And Dislocations | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Carbohydrate Tolerance Analyses (Incl Diabetes) | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Liver Function Analyses | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Metabolism Tests Nec | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Mineral And Electrolyte Analyses | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Platelet Analyses | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Protein Analyses Nec | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Renal Function Analyses | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Skeletal And Cardiac Muscle Analyses | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Tissue Enzyme Analyses Nec | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Vascular Tests Nec (Incl Blood Pressure) | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| White Blood Cell Analyses | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Hyperlipidaemias Nec | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lipid Metabolism And Deposit Disorders Nec | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Potassium Imbalance | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Protein Metabolism Disorders Nec | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Joint Related Signs And Symptoms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Muscle Related Signs And Symptoms Nec | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Musculoskeletal And Connective Tissue Pain And Discomfort | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Musculoskeletal And Connective Tissue Signs And Symptoms Nec | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rheumatoid Arthropathies | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Soft Tissue Disorders Nec | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Central Nervous System Haemorrhages And Cerebrovascular Accidents | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Headaches Nec | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Memory Loss (Excl Dementia) | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Neurological Signs And Symptoms Nec | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Structural Brain Disorders Nec | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Confusion And Disorientation | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Disturbances In Initiating And Maintaining Sleep | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Urinary Abnormalities | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Breathing Abnormalities | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Coughing And Associated Symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lower Respiratory Tract Inflammatory And Immunologic Conditions | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nasal Disorders Nec | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pneumothorax And Pleural Effusions Nec | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dermatitis Ascribed To Specific Agent | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rashes, Eruptions And Exanthems Nec | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Skin Haemorrhages | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Blood Pressure Disorders Nec | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Haemorrhages Nec | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lymphangiopathies | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lymphoedemas | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Peripheral Aneurysms And Dissections | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vascular Hypotensive Disorders | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Measurements |
|---|
|
| NYHA IV |
|
| Death |
|
| Title | Measurements |
|---|
|
| NYHA IV |
|
| Death |
|
| Title | Measurements |
|---|
|
| NYHA IV |
|
| Death |
|
| Title | Measurements |
|---|
|
| NYHA IV |
|
| Death |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|