Overview

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

Summary

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
Arm
(Experimental)
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

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

Secondary Outcomes

Measure
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

  • 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.
  • Patient has been informed of the nature of the trial and has signed an Informed Consent Form.
  • Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.

Exclusion Criteria

  • 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

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.