Aortic Valve StenosisNCT01437098
Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
A study testing MDT-2111 CoreValve for TAVI in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 4 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- MDT-2111 CoreValve for TAVI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 4 sitesJapan
- Study dates
- Oct 2011to 27 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject must have co-morbidities such that one cardiologist and one cardiac surgeons 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.
- Subject has been informed of the nature of the trial and has signed an Informed Consent Form.
- Subject agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.
Who cannot join
- 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:
- Leukopenia (WBC count < 1,000 cells/mm³)
- Thrombocytopenia (platelet count <50,000 cells/mm³)
- History of bleeding diathesis or coagulopathy
Show all 53Show fewer
- Hypercoagulable states
- 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:
- Aspirin
- Ticlopidine
- Heparin
- Contrast media
- Nitinol (titanium and nickel alloy)
- 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 < 20 mm or > 27 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 > 43 mm (in case of the aortic annulus is 23-27 mm) unless the aortic annulus is 20-23 mm in which case the ascending aorta diameter > 40 mm.
- Congenital bicuspid or unicuspid valve verified by echocardiography.
- For patients with native coronary artery dependent circulation:
- Sinus of valsalva width < 29 mm unless the aortic annulus is 20-23 mm, in which case the sinus of valsalva width < 27 mm, OR
- Height of the left or right coronary sinus of valsalva (to the tubular aorta) < 15mm.
- Femoral or iliac artery of the first choice corresponding to any one of the followings:
- Angle at aortic root (the angle between aortic valve annulus plane and horizontal plane/vertebra) exceeds 70°.
- Vessel diameter of femoral or iliac artery is less than 6 mm.
- Aorta has severe calcification, excess tortuosity or severe atherosclerosis.
- Transarterial access not able to accommodate an 18Fr sheath.
- Subclavian artery of the second choice corresponding to any one of the followings:
- Angle at aortic root (the angle between aortic valve annulus plane and horizontal plane/vertebra) exceeds 70° (in the case of left subclavian artery) and 30° (in the case of right subclavian artery).
- Vessel diameter of subclavian artery is less than 6 mm.
- Transarterial access not able to accommodate an 18Fr sheath.
- Direct Aortic Artery as third line choice of access. Patients are excluded from Direct Aortic access if:
- Access site is less than 6 cm from the aortic valve basal plane
- Access site has calcification or porcelain aorta
- Access site and delivery trajectory contain RIMA or patent RIMA graft
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Saitama Medical University
Hidaka, Saitama, 350-1298
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533
Osaka University Hospital
Suita, Osaka, 565-0871
National Cerebral and Cardiovascular Center
Suita, Osaka, 565-8565
About this study
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.
Read the detailed description
Non-randomized, prospective, multicenter, single-arm trial.
- Conditions
- Aortic Valve Stenosis
- Being tested
- MDT-2111 CoreValve for TAVI
- Keywords
- Valvular Heart Disease, Severe Aortic Stenosis, Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDT-2111 CoreValve for TAVIDevice
CoreValve Transcatheter Aortic Valve Implantation (TAVI) using the MDT-2111 system.
| Study group | Role | What they receive |
|---|---|---|
| MDT-2111 CoreValve TAVI | Experimental | Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 CoreValve system. Access sites for the implant include: Iliofemoral, Subclavian and Direct Aortic. Receives: Device: MDT-2111 CoreValve for TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months
Secondary outcomes (47)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: after procedure or discharge
Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.
Measured: after procedure or discharge
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Measured: 30 days
Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient
Measured: 6 months
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Measured: 12 months
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Measured: 24 months
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Measured: 36 months
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Measured: 30 days
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Measured: 6 months
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Measured: 12 months
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Measured: 24 months
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Measured: 36 months
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Measured: 30 days
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Measured: 6 months
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Measured: 12 months
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Measured: 24 months
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Measured: 36 months
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Measured: 30 days
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Measured: 6 months
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Measured: 12 months
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Measured: 24 months
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Measured: 36 months
Repeat Hospitalization
Measured: 0 day to 30 days
Repeat Hospitalization
Measured: 0 day to 6 months
Repeat Hospitalization
Measured: 0 day to 12 months
Repeat Hospitalization
Measured: 0 day to 24 months
Repeat Hospitalization
Measured: 0 day to 36 months
Valve-related Deaths
Measured: 0 day to 30 days
Valve-related Deaths
Measured: 0 day to 6 months
Valve-Related Deaths
Measured: 0 day to 12 months
Valve-related Deaths
Measured: 0 day to 24 months
Valve-related Deaths
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437098
- Sponsor's protocol ID
- MDT-2111
- Status last verified
- Oct 2018
- First submitted
- 16 Sep 2011
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28321003Sawa Y, Saito S, Kobayashi J, Niinami H, Kuratani T, Maeda K, Kanzaki H, Komiyama N, Tanaka Y, Boyle A, Zhang A, Moore BJ, de Medeiros R; MDT-2111 Japan Investigators. First clinical trial of a self-expandable transcatheter heart valve in Japan in patients with symptomatic severe aortic stenosis. Circ J. 2014;78(5):1083-90. doi: 10.1253/circj.cj-14-0162. Epub 2014 Mar 21.
PubMed 24662399
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT01437098
- Acronym / sponsor ID
- MDT-2111
- Conditions
- Aortic Valve Stenosis
- Keywords
- Valvular Heart Disease, Severe Aortic Stenosis, Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 20 Sep 2011 (estimated)
- Results
- Posted 6 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-randomized, prospective, multicenter, single-arm trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDT-2111 CoreValve TAVI | Experimental | Device: MDT-2111 CoreValve for TAVITranscatheter Aortic Valve Implantation (TAVI) with MDT-2111 CoreValve system. Access sites for the implant include: Iliofemoral, Subclavian and Direct Aortic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must have co-morbidities such that one cardiologist and one cardiac surgeons 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.
- Subject has been informed of the nature of the trial and has signed an Informed Consent Form.
Key exclusion criteria (53 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDT-2111 CoreValve for TAVICoreValve Transcatheter Aortic Valve Implantation (TAVI) using the MDT-2111 system. | Device | MDT-2111 CoreValve TAVI |
Primary outcome
Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).
Time frame: baseline and 6 months
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.
47 secondary outcomes
NYHA Classification Over Time
Time frame: 30 days
NYHA Classification Over Time
Time frame: 6 months
NYHA Classification Over Time
Time frame: 12 Months
NYHA Classification Over Time
Time frame: 24 Months
NYHA Classification Over Time
Time frame: 36 Months
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Time frame: 0 day to 30 days
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Time frame: 0 day to 6 months
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Time frame: 0 day to 12 months
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Time frame: 0 day to 24 months
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Time frame: 0 day to 36 months
Device Success as Defined in the Description.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28321003Sawa 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.
- Derived from this study: PubMed 24662399Sawa Y, Saito S, Kobayashi J, Niinami H, Kuratani T, Maeda K, Kanzaki H, Komiyama N, Tanaka Y, Boyle A, Zhang A, Moore BJ, de Medeiros R; MDT-2111 Japan Investigators. First clinical trial of a self-expandable transcatheter heart valve in Japan in patients with symptomatic severe aortic stenosis. Circ J. 2014;78(5):1083-90. doi: 10.1253/circj.cj-14-0162. Epub 2014 Mar 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDT-2111 CoreValve for TAVI in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA). (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01437098, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.