Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:10/24/2018
Start Date:February 2012
End Date:October 2019

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Medtronic CoreValve® Continued Access Study

The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve®
System in the treatment of symptomatic severe aortic stenosis in subjects who have a
predicted very high risk and high risk for aortic valve surgery.


Inclusion Criteria:

1. High Risk: Subject must have co-morbidities such that one cardiologist and two cardiac
surgeons agree that predicted risk of operative mortality is ≥15% (and predicted
operative mortality or serious, irreversible morbidity risk of < 50%) at 30 days.

OR

Extreme Risk: Subject must have co-morbidities such that one cardiologist and two
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. Specifically, the predicted operative risk of death or
serious, irreversible morbidity is ≥ 50% at 30 days.

2. Subject has senile degenerative aortic valve stenosis with:

- Mean gradient > 40 mmHg, or jet velocity greater than 4.0 m/sec 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 or simultaneous pressure recordings at cardiac
catheterization

3. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York
Heart Association (NYHA) Functional Class II or greater.

4. The subject or the subject's legal representative has been informed of the nature of
the trial, agrees to its provisions and has provided written informed consent as
approved by the IRB of the respective clinical site.

5. The subject and the treating physician agree that the subject will return for all
required post-procedure follow-up visits.

Exclusion Criteria:

Clinical

1. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.

2. Any percutaneous coronary or peripheral interventional procedure performed within 30
days prior to the MCS TAVI procedure including bare metal and drug eluting stents.

3. Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet
count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.

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 or creatinine clearance < 20
cc/min.

10. Active GI bleeding that would preclude anticoagulation.

11. A known hypersensitivity or contraindication to any of the following which cannot be
adequately pre-medicated:

- Aspirin

- Heparin (HIT/HITTS) and bivalirudin

- Nitinol (titanium or nickel)

- Ticlopidine and clopidogrel

- Contrast media

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.

18. Symptomatic carotid or vertebral artery disease.

Anatomical

19. High Risk:Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic
imaging (until 23mm valve enrollment completion/closure in the CoreValve® US Pivotal
Trial-High Risk Cohort)

OR

Extreme Risk: Native aortic annulus size < 18 mm or > 29 mm per the baseline
diagnostic imaging. (High risk and extreme risk upon 23mm valve enrollment
completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort)

20. Pre-existing prosthetic heart valve any position.

21. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation (3-4+)).

22. Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid
regurgitation.

23. Moderate to severe mitral stenosis.

24. Hypertrophic obstructive cardiomyopathy.

25. Echocardiographic evidence of new or untreated intracardiac mass, thrombus or
vegetation.

26. Severe basal septal hypertrophy with an outflow gradient.

27. Aortic root angulation (angle between plane of aortic valve annulus and horizontal
plane/vertebrae) > 70° (for femoral and left subclavian/axillary access) and > 30°
(for right subclavian/axillary access).

28. Ascending aorta diameter >43 mm if the aortic annulus diameter is 23-29 mm; ascending
aortic diameter > 40 mm if the aortic annulus diameter is 20-23 mm; or an ascending
aorta diameter > 34 mm if the aortic annulus diameter is 18-20 mm (Extreme Risk only
until 23 mm valve enrollment completion/closure in the CoreValve® US Pivotal
Trial-High Risk Cohort).

29. Congenital bicuspid or unicuspid valve verified by echocardiography.

30. Sinus of valsalva anatomy that would prevent adequate coronary perfusion.

Vascular

31. Transarterial access not able to accommodate an 18Fr sheath.
We found this trial at
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3300 Gallows Road
Falls Church, Virginia 22042
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1 Gustave L Levy Pl # 271
New York, New York 10029
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Ann Arbor, Michigan 48109
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Atlanta, Georgia 30309
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
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Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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1800 Orleans St.
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Burlington, Vermont 05405
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3535 Olentangy River Rd
Columbus, Ohio 43214
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Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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100 North Academy Avenue
Danville, Pennsylvania 17822
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Des Moines, Iowa 50314
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Detroit, Michigan 48236
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2301 Erwin Rd
Durham, North Carolina 27710
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Grand Rapids, Michigan 49503
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Harrisburg, Pennsylvania 17043
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80 Seymour St
Hartford, Connecticut 6102
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Indianapolis, Indiana 46260
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Kansas City, Kansas 66160
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4733 Sunset Blvd
Los Angeles, California 90027
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300 Community Drive
Manhasset, New York 11030
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2160 South 1st Avenue
Maywood, Illinois 60153
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Miami Beach, Florida 33140
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100 Madison Ave
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2500 Grant Rd
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20 York St, N20 York St,
New Haven, Connecticut 06520
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New York, New York 10021
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New York, New York 10016
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3801 Miranda Avenue
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Phoenix, Arizona
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200 Lothrop St
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Roslyn, New York 11576
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1 Medical Center Blvd
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