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Clinical Trials/NCT01437098
NCT01437098CompletedNot Applicable

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

Medtronic Cardiovascular8 sites in 1 country55 target enrollmentStarted: October 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
55
Locations
8
Primary Endpoint
Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 surgical operation.

Detailed Description

Non-randomized, prospective, multicenter, single-arm trial.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.
  • •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 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:
  • •Ticlopidine
  • •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
  • +1 more not shown

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • NYHA Classification Over Time(36 Months)
  • Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)(0 day to 36 months)
  • Valve-related Deaths(0 day to 36 months)
  • Device Success as Defined in the Description.(after procedure or discharge)
  • Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)(36 months)
  • Valve-Related Deaths(0 day to 12 months)
  • Repeat Hospitalization(0 day to 36 months)
  • Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)(Baseline to 36 Months)
  • Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.(after procedure or discharge)
  • Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient(36 months)
  • Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient(6 months)
  • Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)(36 months)
  • Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)(36 months)

Investigators

Sponsor
Medtronic Cardiovascular
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (8)

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