Status:
COMPLETED
Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
Phase:
NA
Brief 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 surgic...
Detailed Description
Non-randomized, prospective, multicenter, single-arm trial.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2018
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01437098
Start Date
October 1 2011
End Date
November 27 2018
Last Update
February 15 2019
Active Locations (4)
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1
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan, 247-8533
2
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
3
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan, 565-8565
4
Saitama Medical University
Hidaka, Saitama, Japan, 350-1298