Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:1/9/2019
Start Date:March 2016
End Date:March 2026
Contact:Joleen Perkins
Email:joleen.perkins@medtronic.com
Phone:1-763-514-9731

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Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR
system as measured by rates of all-cause mortality or disabling stroke at two years is
noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low
predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial
protocol is to conclude the randomized phase of the trial and initiate the single-arm,
non-randomized, continued access phase of the trial.

Multi-center, international, prospective, randomized, interventional, pre-market.

Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to
SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year,
18 months, and annually through 10 years.

The expanded use addendum is a multi-center, prospective, non-randomized continued access
trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR
system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually
through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United
States.

Inclusion Criteria:

1. Severe aortic stenosis, defined as follows:

1. For symptomatic patients:

Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean
gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic
echocardiography at rest

2. For asymptomatic patients:

- Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic
valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec ,
or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR

- Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2),
AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by
transthoracic echocardiography at rest, AND an exercise tolerance test that
demonstrates a limited exercise capacity, abnormal BP response, or
arrhythmia OR

- Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2),
AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by
transthoracic echocardiography at rest, AND a left ventricular ejection
fraction <50%.

2. Documented heart team agreement of low risk for SAVR, where low risk is defined as
predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart
team assessment.

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

Exclusion Criteria:

1. Any condition considered a contraindication for placement of a bioprosthetic valve
(eg, subject is indicated for mechanical prosthetic valve).

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

1. aspirin or heparin (HIT/HITTS) and bivalirudin

2. ticlopidine and clopidogrel

3. Nitinol (titanium or nickel)

4. contrast media

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

4. Ongoing sepsis, including active endocarditis.

5. Any percutaneous coronary or peripheral interventional procedure with a bare metal
stent within 30 days prior to randomization, or drug eluting stent performed within
180 days prior to randomization.

6. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left
main coronary artery.

7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid
stenosis within 10 weeks of Heart Team assessment.

8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or
mechanical hemodynamic support.

9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or
transient ischemic attack (TIA).

10. Gastrointestinal (GI) bleeding that would preclude anticoagulation.

11. Subject refuses a blood transfusion.

12. 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).

13. Estimated life expectancy of less than 24 months due to associated non-cardiac
co-morbid conditions.

14. Other medical, social, or psychological conditions that in the opinion of the
investigator precludes the subject from appropriate consent or adherence to the
protocol required follow-up exams.

15. Currently participating in an investigational drug or another device trial (excluding
registries).

16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to
unstable coronary artery disease (WHO criteria).

17. Need for emergency surgery for any reason.

18. Subject is pregnant or breast feeding.

19. Subject is less than legal age of consent, legally incompetent, or otherwise
vulnerable

20. Pre-existing prosthetic heart valve in any position.

21. Severe mitral regurgitation amenable to surgical replacement or repair.

22. Severe tricuspid regurgitation amenable to surgical replacement or repair.

23. Moderate or severe mitral stenosis amenable to surgical replacement or repair.

24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.

25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.

26. Prohibitive left ventricular outflow tract calcification.

27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding
bioprosthesis.

28. Aortic annulus diameter of <18 or >30 mm.

29. Significant aortopathy requiring ascending aortic replacement.

For transfemoral or transaxillary (subclavian) access:

30. Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access
vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for
transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean
diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter
<6.0 mm for the Evolut 34R or Evolut PRO TAV.
We found this trial at
62
sites
1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Principal Investigator: David Cox, MD
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ignacio Inglessis, MD
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Jeffrey Popma, MD
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Mark Robbins, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Firas Zahr, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Stanley Chetcuti, MD
University of Michigan Health System The University of Michigan is home to one of the...
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Atlanta, Georgia 30309
Principal Investigator: Christopher Meduri, MD
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: John Carroll, MD
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Baltimore, Maryland 21218
Principal Investigator: John Wang, MD
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Jon Resar, MD
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Bartley Griffith, MD
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Burlington, Vermont 05405
Principal Investigator: Harold Dauerman, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Daniel Steinberg, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Cincinnati, Ohio 45220
Principal Investigator: Puvi Seshiah, MD
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Clearwater, Florida 33756
Principal Investigator: Douglas Spriggs, MD
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Cleveland, Ohio 44194
Principal Investigator: Alan Markowitz, MD
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Columbus, Ohio 43214
Principal Investigator: Steven Yakubov, MD
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Scott Lilly
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Dallas, Texas 75226
Principal Investigator: Robert C. Stoler, MD
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100 North Academy Avenue
Danville, Pennsylvania 17043
Principal Investigator: Alfred Casale, MD
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Delray Beach, Florida 33431
Principal Investigator: Brijeshwar Maini, MD
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Des Moines, Iowa 50314
Principal Investigator: Atul Chawla, MD
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22101 Moross Rd
Detroit, Michigan 48236
(313) 343-4000
Principal Investigator: Sanjay Batra, MD
Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: J. Kevin Harrison, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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2200 New York 25A
East Hills, New York 11548
Principal Investigator: George A. Petrossian, MD
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Fargo, North Dakota 58122
Principal Investigator: Thomas A Haldis, MD
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9981 South Healthpark Drive
Fort Myers, Florida 33908
Principal Investigator: Brian Hummel, MD
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Grand Rapids, Michigan 49503
Principal Investigator: William Merhi, DO
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Harrisburg, Pennsylvania 17043
Principal Investigator: Mubashir Mumtaz, M.D.
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Houma, Louisiana 70360
Principal Investigator: Peter Fail, MD
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Michael Reardon, MD
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Houston, Texas 77030
Principal Investigator: Joseph Coselli, MD
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10580 North Meridian Street
Indianapolis, Indiana 46290
Principal Investigator: James Hermiller, MD
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Kansas City, Kansas 66160
Principal Investigator: Peter Tadros, MD
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La Jolla, California 92037
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Liverpool, New York
Principal Investigator: Ronald Caputo, MD
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Los Angeles, California 90033
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Louisville, Kentucky 40202
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Manhasset, New York 11030
Principal Investigator: Bruce Rutkin, MD
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Ferdinand Leya, MD
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
Principal Investigator: Eduardo de Marchena, MD
University of Miami Hospital The University of Miami changed the face of modern health care...
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Milwaukee, Wisconsin 53215
Principal Investigator: Tanvir Bajwa, MD
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Principal Investigator: Paul Sorajja, MD
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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2500 Grant Rd
Mountain View, California 94040
(650) 940-7000
Principal Investigator: Ajanta De, MD
El Camino Hospital El Camino Hospital is a nonprofit organization with hospital campuses in Mountain...
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: John Forrest, MD
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New York, New York 10029
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Oklahoma City, Oklahoma
Principal Investigator: Jeffrey Sparling, MD
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Phoenix, Arizona 85006
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Thomas G. Gleason, MD
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5801 Bremo Road
Richmond, Virginia 23226
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Rochester, New York 14642
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Sacramento, California 95819
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50 North Medical Drive
Salt Lake City, Utah 84132
Principal Investigator: Frederick Welt, MD
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San Antonio, Texas 78229
Principal Investigator: Jorge Alvarez, MD
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5300 Tallman Ave NW
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(206) 782-2700
Principal Investigator: Sameer Gafoor, MD
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Principal Investigator: Ashequl Islam, MD
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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Springfield, Missouri 65804
Principal Investigator: Robert Merritt, MD
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St Leonards, New South Wales 2065
Principal Investigator: Ravinay Bhindi, MD
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Tallahassee, Florida 32308
Principal Investigator: Thomas Noel, MD
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Thousand Oaks, California 91360
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Winchester, Virginia 22604
Principal Investigator: Basel Ramlawi, MD
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Winston-Salem, North Carolina 27157
Principal Investigator: David Zhao, MD
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