This trial is active, not recruiting.

Condition aortic valve stenosis
Treatment mdt-2111 system for transcatheter aortic valve implantation (tavi)
Sponsor Medtronic Cardiovascular
Start date October 2011
End date May 2013
Trial size 40 participants
Trial identifier NCT01437098, MDT-2111


The primary objective of the present trial is to demonstrate the effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed difficult for surgical operation.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
mdt-2111 system for transcatheter aortic valve implantation (tavi)
Transcatheter Aortic Valve Implantation (TAVI) using the MDT-2111 system.

Primary Outcomes

Change in composite score of New York Heart Association (NYHA) Class and effective orifice area (EOA).
time frame: baseline and 6 months

Secondary Outcomes

Change in NYHA classification from baseline.
time frame: baseline and 30 days, 6 months, 12 months, and annually thereafter up to five years
The occurrence of individual Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) components
time frame: 5 years
Device success as defined in the description.
time frame: from admission for procedure to discharge, on average less than 1 week
Procedural success, defined as device success and absence of in-hospital MACCE.
time frame: from admission for procedure to discharge, on average less than 1 week
Echocardiographic assessment of prosthetic valve performance
time frame: 5 years
Repeat hospitalization
time frame: 5 years
Valve-related deaths
time frame: 5 years
All adverse events
time frame: 5 years
Quality of Life assessment using SF-36 questionnaire.
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Patient has been informed of the nature of the trial and has signed an Informed Consent Form. 5. Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed. Exclusion Criteria: 1. Evidence of an acute myocardial infarction ≤ 30 days prior to the intended treatment. 2. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the procedure. 3. 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 4. Untreated clinically significant coronary artery disease requiring revascularization. 5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. 6. Need for emergency surgery for any reason. 7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as measured by resting echocardiogram. 8. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack(TIA). 9. End stage renal disease requiring chronic dialysis. 10. GI bleeding within the past 3 months. 11. 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) 12. Ongoing sepsis, including active endocarditis. 13. Subject refuses a blood transfusion. 14. Life expectancy < 12 months due to associated non-cardiac co-morbid conditions. 15. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent. 16. 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). 17. 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. 18. Symptomatic carotid or vertebral artery disease. 19. Native aortic annulus size < 20 mm or > 27 mm per the screening diagnostic imaging. 20. Pre-existing prosthetic heart valve in any position. 21. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation). 22. Mitral regurgitation (moderate to severe) or severe tricuspid regurgitation. 23. Moderate to severe mitral stenosis. 24. Hypertrophic obstructive cardiomyopathy. 25. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 26. Severe basal septal hypertrophy with an outflow gradient. 27. 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. 28. Congenital bicuspid or unicuspid valve verified by echocardiography. 29. 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. 30. 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. 31. 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. 32. 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

Additional Information

Official title Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.