Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01634269
First received: July 2, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 with small aortic annuli and deemed difficult for surgical operation.


Condition Intervention
Aortic Valve Stenosis
Device: MDT-2111 TAVI 23 mm

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Change in composite score of New York Heart Association (NYHA) Class and effective orifice area (EOA). [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in NYHA classification from baseline [ Time Frame: baseline and 30 days, 6 months, 12 months, and annually thereafter up to five years ] [ Designated as safety issue: No ]
  • The occurrence of individual Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) components [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

    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)

  • Device success as defined in the description. [ Time Frame: from admission for procedure to discharge, on average less than 1 week ] [ Designated as safety issue: Yes ]
    • 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

  • 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 ] [ Designated as safety issue: No ]
  • Echocardiographic assessment of prosthetic valve performance [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
    Measured by transvalvular mean gradient, effective orifice area, degree of aortic valve regurgitation (transvalvular and paravalvular), left ventricular ejection fraction (LVEF).

  • Repeat hospitalization [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • Valve-related deaths [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • All adverse events [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • Quality of Life assessment using SF-36 questionnaire [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: July 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDT-2111 TAVI 23 mm Device: MDT-2111 TAVI 23 mm
Device: 23 mm MDT-2111 System for Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 < 18 mm or > 20 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 > 34 mm
  28. Congenital bicuspid or unicuspid valve verified by echocardiography.
  29. For patients with native coronary artery dependent circulation:

    • Sinus of valsalva width < 25 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01634269

Locations
Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Osaka University Hospital
Suita-Shi, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita-shi, Osaka, Japan
Saitama Medical University
Hidaka-shi, Saitama, Japan
Sponsors and Collaborators
Medtronic Cardiovascular
  More Information

No publications provided

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01634269     History of Changes
Other Study ID Numbers: MDT-2111 23 mm trial
Study First Received: July 2, 2012
Last Updated: April 7, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Medtronic Cardiovascular:
Valvular Heart Disease
Severe Aortic Stenosis
Aortic Valve Replacement

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014