Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:10/19/2018
Start Date:April 2012
End Date:November 2026

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Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic
valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at
intermediate surgical risk by randomizing patients to either Surgical Aortic Valve
Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of
transcatheter aortic valve implementation (TAVI) in patients with sever symptomatic Aortic
Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the
pivotal clinical trial.


Inclusion Criteria:

- Subject must have co-morbidities such that Heart Team agrees predicted risk of
operative mortality is ≥3% and <15% at 30 days (Intermediate Clinical Risk
classification). Heart team evaluation of clinical surgical mortality risk for each
patient includes the calculated STS score for predicted risk of surgical mortality
augmented by consideration of the overall clinical status and co-morbidities
unmeasured by the STS risk calculation;

- Heart Team unanimously agree on treatment proposal and eligibility for randomization*
based on their clinical judgement (including anatomy assessment, risk factors, etc.);

- Subject has severe aortic stenosis presenting with;

1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or
aortic valve area index < 0.6cm2/m2 AND

2. Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous
pressure recordings at cardiac catherization [or with dobutamine stress, if
subject has left ventricular ejection fraction (LVEF) <55%] or velocity ratio <
0.25;

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

- Subject and the treating physician agree that the subject will return for all required
post-procedure follow-up visits;

- Subject meets the legal minimum age to provide informed consent based on local
regulatory requirements;

Exclusion Criteria:

- Subject has refused surgical aortic valve replacement (SAVR) as a treatment option;
(not applicable for Single Arm)

- Any condition considered a contraindication for placement of a bioprosthetic valve
(i.e., subject requires a mechanical valve);

- A known hypersensitivity or contraindication to all anticoagulation/antiplatelet
regimens (or inability to be anticoagulated for the index procedure), nitinol, or
sensitivity to contrast media which cannot be adequately pre-medicated;

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

- Ongoing sepsis, including active endocarditis;

- Any condition considered a contraindication to extracorporeal assistance;

- Any percutaneous coronary or peripheral interventional procedure performed within 30
days prior to randomization* (Subjects with recent placement of drug eluting stent(s)
should be assessed for ability to safely proceed with SAVR within the protocol
timeframe);

- Symptomatic carotid or vertebral artery disease or successful treatment of carotid
stenosis within six weeks of randomization*;

- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or
mechanical hemodynamic support;

- Recent (within 6 months of randomization*) cerebrovascular accident (CVA) or transient
ischemic attack (TIA);

- Active gastrointestinal (GI) bleeding that would preclude anticoagulation;

- Subject refuses a blood transfusion;

- 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);

- Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left
main coronary artery (Syntax score calculation is not required for patients with
history of previous revascularization if repeat revascularization is not planned);

- Estimated life expectancy of less than 24 months due to associated non-cardiac
comorbid conditions;

- 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;

- Currently participating in an investigational drug or another device trial (excluding
registries);

- Evidence of an acute myocardial infarction ≤30 days before the index procedure;

- Need for emergency surgery for any reason;

- True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);

- Extensive mediastinal radiation;

- Liver failure (Child-C);

- Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as
measured by resting echocardiogram;

- Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);

- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up
requirements;

- End stage renal disease requiring chronic dialysis or creatinine clearance < 20
cc/min;

- Pulmonary Hypertension (systolic pressure> 80mmHg);

- Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory
Volume (FEV1) < 750cc;

- Frailty assessments identify:

1. Subject is < 80 years of age and three or more of the following apply

2. Subject is ≥ 80 years of age and two or more of the following apply

- Wheelchair bound

- Resides in an institutional care facility (e.g., nursing home, skilled care
center)

- Body Mass Index < 20 kg/m2

- Grip Strength < 16 kg

- Katz Index Score ≤ 4

- Albumin < 3.5 g/dL;

- Marfan syndrome or other known connective tissue disease that would necessitate aortic
root replacement/intervention; (Not applicable for Single Arm)

Note: Additional anatomical and vascular exclusion criteria may apply.

Note: * For purposes of the single arm phase of the trial, "randomization" will refer to
trial enrollment.
We found this trial at
66
sites
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Barry George, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Vasilis Babliaros, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Jon Resar, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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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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Boston, MA
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
Principal Investigator: Harold Dauermann, MD
Phone: 802-847-0000
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: Alan Hartman, MD
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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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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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Peter A. Knight, MD
Phone: 585-273-4956
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Ann Arbor, Michigan 48109
Principal Investigator: Stanley J Chetcuti, MD
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Atlanta, Georgia 30309
Principal Investigator: James Kauten, MD
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Janah Aji, MD
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Charlotte, North Carolina 28203
Principal Investigator: Michael Rinaldi, MD
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Cincinnati, Ohio 45220
Principal Investigator: Puvi Seshiah, MD
Phone: 513-862-3305
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Clearwater, Florida 33756
Principal Investigator: Lang Lin, 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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Coral Gables, Florida 33146
Principal Investigator: Tomas A Salerno, MD
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Dallas, Texas 75226
Principal Investigator: Robert Hebeler, MD
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Alfred Casale, MD
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Delray Beach, Florida 33431
Principal Investigator: Brijeshwar Maini, MD
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Detroit, Michigan 48201
Principal Investigator: Theodore Schreiber, MD
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Detroit, Michigan 48202
Principal Investigator: William O'Neill, MD
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Detroit, Michigan 48236
Principal Investigator: Thomas Davis, MD
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: J Kevin Harrison, MD
Phone: 919-668-0903
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Grand Rapids, Michigan 49503
Principal Investigator: John C Heiser, MD
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
Principal Investigator: Raymond McKay, MD
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hollywood, California 90048
Principal Investigator: Raj Makkar, MD
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Principal Investigator: Jeffrey Lau, MD
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Houma, Louisiana 70360
Principal Investigator: Edgar Feinberg, II, MD
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Houston, Texas 77030
Principal Investigator: Michael Reardon, MD
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Indianapolis, Indiana 46260
Principal Investigator: David A Heimansohn, MD
Phone: 317-583-5000
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Kansas City, Kansas 66160
Principal Investigator: George "Trip" Zorn, MD
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Kansas City, Missouri 64111
Principal Investigator: Adnan Chhatriwalla, MD
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La Jolla, California 92037
Principal Investigator: Paul Teirstein, MD
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Los Angeles, California 90033
Principal Investigator: Ray Matthews, MD
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Maywood, Illinois 60153
Principal Investigator: Mamdouh Bakhos, MD
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Memphis, Tennessee 38120
Principal Investigator: Basil M Paulus, MD
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Principal Investigator: Daniel O'Hair, MD
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Richard Schwartz, MD
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Minneapolis, Minnesota 55407
Principal Investigator: Paul Sorajja, MD
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Morristown, New Jersey 07962
Principal Investigator: John Brown, MD
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2500 Grant Rd
Mountain View, California 94040
(650) 940-7000
Principal Investigator: James Joye, MD
El Camino Hospital El Camino Hospital is a nonprofit organization with hospital campuses in Mountain...
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Brian Whisenant, MD
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Abeel Mangi, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New York, New York 10021
Principal Investigator: Derek Brinster, MD
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: James Slater, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Susheel Kodali, MD
Phone: 212-305-7060
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York 10029
Principal Investigator: David Adams, MD
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Norfolk, Virginia 23507
Principal Investigator: Paul Mahoney, MD
Phone: 757-388-6144
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4050 West Memorial Road
Oklahoma City, Oklahoma 73120
Principal Investigator: Mohammad K.J. Ghani, MD
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Omaha, Nebraska 68124
Principal Investigator: Himanshu Argarwal Satpathy, MD
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3801 Miranda Avenue
Palo Alto, California 94304
650-493-5000
Principal Investigator: John Giacomini, MD
VA Palo Alto Health Care System The VA Palo Alto Health Care System (VAPAHCS) consists...
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Pasadena, California 91101
Principal Investigator: Vicken Aharonian, MD
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Philadelphia, Pennsylvania 19104
Principal Investigator: Howard Herrmann, MD
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Phoenix, Arizona 85006
Principal Investigator: Timothy Byrne, DO
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Thomas Gleason, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Plano, Texas 75093
Principal Investigator: David Brown, MD
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Richmond, Virginia 23226
Principal Investigator: David Scott Lim, MD
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Rochester, Minnesota 55902
Principal Investigator: Gurpreet Sandhu, MD
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Roslyn, New York 11576
Principal Investigator: George Petrossian, MD
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Principal Investigator: Alan Yeung, MD
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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West Des Moines, Iowa 50266
Principal Investigator: Atul Chawla, MD
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Robert J. Applegate, MD
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Wormleysburg, Pennsylvania 17043
Principal Investigator: William Bachinsky, MD
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