The primary objective of the present trial is to demonstrate the effectiveness and safety of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed difficult for surgical operation.
Non-randomized, prospective, multicenter, single-arm trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
CoreValve Transcatheter Aortic Valve Implantation (TAVI) using the MDT-2111 system.
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Osaka University Hospital
Suita, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Saitama Medical University
Hidaka, Saitama, Japan
Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).
The primary endpoint was defined as the proportion of implanted subjects with improvement of at least 1 NYHA class from baseline to 6 months and EOA greater than 1.2 cm² at 6 months.
Time frame: baseline and 6 months
NYHA Classification Over Time
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 30 days
NYHA Classification Over Time
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
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Time frame: 6 months
NYHA Classification Over Time
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 12 Months
NYHA Classification Over Time
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 24 Months
NYHA Classification Over Time
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 36 Months
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
MACCE is defined as a composite of: * all-cause death * myocardial infarction (MI) * all stroke, and * reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 0 day to 30 days
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
MACCE is defined as a composite of: * all-cause death * myocardial infarction (MI) * all stroke, and * reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 0 day to 6 months
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
MACCE is defined as a composite of: * all-cause death * myocardial infarction (MI) * all stroke, and * reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 0 day to 12 months
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
MACCE is defined as a composite of: * all-cause death * myocardial infarction (MI) * all stroke, and * reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 0 day to 24 months
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
MACCE is defined as a composite of: * all-cause death * myocardial infarction (MI) * all stroke, and * reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 0 day to 36 months
Device Success as Defined in the Description.
* successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system * correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function) * Intended performance of the prosthetic valve (aortic valve area \>1.2 cm² (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/sec, without moderate or severe prosthetic valve AR) * Only one valve implanted in the proper anatomical location
Time frame: after procedure or discharge
Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.
Time frame: after procedure or discharge
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Time frame: 30 days
Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient
Time frame: 6 months
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Time frame: 12 months
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Time frame: 24 months
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Time frame: 36 months
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Time frame: 30 days
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Time frame: 6 months
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Time frame: 12 months
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Time frame: 24 months
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Time frame: 36 months
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Time frame: 30 days
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Time frame: 6 months
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Time frame: 12 months
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Time frame: 24 months
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Time frame: 36 months
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Time frame: 30 days
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Time frame: 6 months
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Time frame: 12 months
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Time frame: 24 months
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Time frame: 36 months
Repeat Hospitalization
Time frame: 0 day to 30 days
Repeat Hospitalization
Time frame: 0 day to 6 months
Repeat Hospitalization
Time frame: 0 day to 12 months
Repeat Hospitalization
Time frame: 0 day to 24 months
Repeat Hospitalization
Time frame: 0 day to 36 months
Valve-related Deaths
Time frame: 0 day to 30 days
Valve-related Deaths
Time frame: 0 day to 6 months
Valve-Related Deaths
Time frame: 0 day to 12 months
Valve-related Deaths
Time frame: 0 day to 24 months
Valve-related Deaths
Time frame: 0 day to 36 months
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)
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 v2TM Scoring Program2,3 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. 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.
Time frame: Baseline to 30 days
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)
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 v2TM Scoring Program2,3 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. 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.
Time frame: Baseline to 6 months
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)
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 v2TM Scoring Program2,3 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. 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.
Time frame: Baseline to 12 months
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)
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 v2TM Scoring Program2,3 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. 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.
Time frame: Baseline to 24 Months
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)
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 v2TM Scoring Program2,3 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. 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.
Time frame: Baseline to 36 Months