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:3/16/2019
Start Date:February 2012
End Date:October 2019

Use our guide to learn which trials are right for you!

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
45
sites
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
(678) 843-7001
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Burlington, Vermont 05405
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
?
mi
from
Danville, PA
Click here to add this to my saved trials
Des Moines, Iowa 50314
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 48236
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17043
?
mi
from
Harrisburg, PA
Click here to add this to my saved trials
?
mi
from
Houma, LA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kansas City, Kansas 66160
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
300 Community Drive
Manhasset, New York 11030
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
2500 Grant Rd
Mountain View, California 94040
(650) 940-7000
El Camino Hospital El Camino Hospital is a nonprofit organization with hospital campuses in Mountain...
?
mi
from
Mountain View, CA
Click here to add this to my saved trials
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
3801 Miranda Avenue
Palo Alto, California 94304
650-493-5000
VA Palo Alto Health Care System The VA Palo Alto Health Care System (VAPAHCS) consists...
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Phoenix, Arizona
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Roslyn, New York 11576
?
mi
from
Roslyn, NY
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Washington, District of Columbia
?
mi
from
Washington,
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials