Transcatheter Aortic Valve Replacement System Pivotal Trial



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:June 2015
End Date:July 2020
Contact:Bryan Petrisko
Email:bpetrisko@directflowmedical.com
Phone:707-576-0420

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SALUS Trial TranScatheter Aortic Valve RepLacement System Pivotal Trial The Safety and Effectiveness of the Direct Flow Medical Tanscatheter Aortic Valve System

Prospective, randomized, unblended, multi-center investigational study with enrollment at up
to 45 Investigational sites. The study is designed to compare the study device (Direct Flow
Medical Transcatheter Aortic Valve System) composite event rate to a comparator (Medtronic
CoreValve commercially available) in high and extreme risk subjects with severe symptomatic
aortic stenosis.

Prospective, randomized, unblended, multi-center investigational study with enrollment at up
to 45 Investigational sites. The study is designed to compare the study device (Direct Flow
Medical Transcatheter Aortic Valve System) composite event rate to a comparator (Medtronic
CoreValve commercially available) in high and extreme risk subjects with severe symptomatic
aortic stenosis.

The primary study endpoint is a composite of all-cause mortality, disabling stroke, or
moderate or greater paravalvular aortic regurgitation (based on core lab assessment) at 1
year. All primary endpoint events will be evaluated by a CEC using the definitions located
in this protocol.

The powered secondary endpoint is the rate of mild or greater paravalvular aortic
regurgitation at 30 days. The objective is to show that the study device rate of
paravalvular aortic regurgitation at 30 days is lower than that observed for the comparator.

Subjects must meet the fundamental enrollment criteria of severe symptomatic, calcific
aortic stenosis with quantifiable and documented source records.

Inclusion Criteria:

1. The subject has severe senile degenerative aortic valve stenosis etermined by resting
or dobutamine stress echocardiogram and Doppler, or simultaneous pressure recordings
at cardiac catheterization defined as: mean aortic gradient ≥40 mmHg or peak jet
velocity ≥4.0 m/s and an aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6
cm2/m2.

2. The subject has moderate to severe symptoms from aortic valve stenosis (NYHA
Functional Class ≥II)

3. Subject has a documented aortic annulus size of ≥19 mm and <29 mm based on the
center's assessment of pre-procedure diagnostic imaging (and confirmed by the Patient
Review Committee [PRC]) and is deemed treatable with an available size of both test
and control device..

4. There is agreement by the heart team (which must include a site cardiac
interventionalist and two cardiac surgeons that are staff members at the hospital
where the procedure is to be performed) that subject is at high operative risk or
greater of serious morbidity or mortality with surgical valve replacement (see note
below for definitions of extreme and high risk, the required level of surgical
assessment, and PRC confirmation) and that TAVR is appropriate. Subjects are judged
by a heart team, including two cardiac surgeons, to be at high or greater risk for
open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score >8% or
at a > 15% risk of mortality at 30 days).This conclusion shall be based on consensus
of one cardiac interventionalist and two cardiac surgeons that have examined the
subject face to face after careful consideration of the Subject's STS risk score and
co-morbidities. NOTE: In the United States, the Centers for Medicare and Medicaid
Services (CMS) require independent evaluations by 2 cardiac surgeons for
reimbursement.

5. Subject understands the study requirements and the treatment procedures, and provides
written informed consent.

6. Subject agrees and is capable of returning to the study hospital for all required
scheduled follow up visits.

Exclusion Criteria:

1. Left ventricular ejection fraction (LVEF) <20% determined by resting echocardiogram.

2. Subjects with an acute STEMI within 30 days preceding the index procedure.

3. Chronic kidney disease (creatinine >3.0 mg/dl, renal replacement therapy at the time
of screening or unstable renal function).

4. Subjects with a platelet count of <50,000 cells/mm³ or a WBC < 1000 cells/mm³ within
7 days prior to index procedure.

5. Subject has a known contraindication or hypersensitivity to all antithrombin regimens
(aspirin, all P2Y12 inhibitors), or inability to be anti-coagulated for the study
procedure. Note: Subjects who require chronic anticoagulation must be able to be
treated additionally with either aspirin or clopidogrel.

6. Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure unless
the BAV is a bridge to the procedure. The bridge BAV must be performed > 72 hours
prior to the index procedure.

7. Subjects who are on a waiting list for any organ transplant.

8. Subjects with known other medical illness associated with a life expectancy of less
than one year, or expectation that subject will not improve despite treatment of
aortic stenosis.

9. Subject has known hypersensitivity to contrast agents that cannot be adequately
pre-medicated, or has known hypersensitivity to nickel, tantalum, titanium, or
polyurethanes

10. Subjects with a history of a stroke or transient ischemic attack TIA) within the
prior 6 months of procedure or screening.

11. Subjects with an active gastrointestinal (GI) bleeding (endoscopy proven or bleeding
precluding Dual antiplatelet therapy) within the prior 3 months.

12. Subjects presenting with hemodynamic instability or cardiogenic shock requiring
inotropic support or mechanical support devices.

13. Subjects who have a planned treatment with any other investigational device or
procedure through 1 year follow-up, or who are currently participating in an
investigational drug or another device trial.

14. Any planned surgical, percutaneous coronary or peripheral procedure to be performed
within the 30 day follow-up from the TAVR procedure.

15. Untreated clinically significant coronary artery disease requiring revascularization.

16. Trans-esophageal echocardiography (TEE) is contraindicated.

17. Active endocarditis or sepsis within 6 months prior to the study procedure.

18. Any condition resulting in inability to provide informed consent for the trial or
difficulty in assessment of neurologic status.

Anatomic and Vascular Exclusions

19. Congenital bicuspid or unicuspid valve (except as outlined in the planned nested
registry).

20. Prior aortic valve surgery or pre-existing prosthetic heart valve in the mitral or
aortic position (mitral and tricuspid rings are permissible).

21. A native valve annulus diameter <19mm or ≥29mm determined by the screening CT scan.

22. Echocardiographic evidence of new intra-cardiac mass untreated thrombus, or
vegetation that requires treatment.

23. >3+: aortic regurgitation, mitral regurgitation or tricuspid regurgitation.

24. Severe mitral stenosis.

25. Thoracic aortic aneurysm (TAA) >5.50 cm.
We found this trial at
24
sites
Atlanta, Georgia 30309
Principal Investigator: Vivek Rajagopal, M.D.
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Atlanta, GA
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Vinid Thourani, M.D.
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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Aurora, Colorado 80045
Principal Investigator: Joseph Cleveland, M.D.
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Aurora, CO
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
Principal Investigator: Anuj Gupta, MD
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Baltimore, MD
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: David Scott Lim, M.D.
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Charlottesville, VA
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Samir Kapadia, M.D.
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Columbus, Ohio 43214
Principal Investigator: Daniel Watson, M.D.
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Columbus, OH
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Dallas, Texas 75246
Principal Investigator: Micael Mack, M.D.
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Dallas, TX
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: William O'Neill, M.D.
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: John Harrison, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Evanston, Illinois 60208
Principal Investigator: James Flaherty, M.D.
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Evanston, IL
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Houma, Louisiana 70360
Principal Investigator: Edgar Feinberg, II, M.D.
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Houma, LA
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Houston, Texas 77030
Principal Investigator: Michael Reardon, M.D.
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Houston, TX
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Indianapolis, Indiana 46290
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Indianapolis, IN
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Losa Angeles, California 90048
Principal Investigator: Wen Cheng, M.D.
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Losa Angeles, CA
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Milano, 20132
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Milano,
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: Paul Mahoney, M.D.
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Norfolk, VA
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Roslyn, New York 11576
Principal Investigator: Newell Robinson, M.D.
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Roslyn, NY
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Sacramento, California 95817
Principal Investigator: Jeffrey Southhard, M.D.
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Sacramento, CA
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Springfield, Illinois 62701
Principal Investigator: Gregory Mishkel, M.D.
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Springfield, IL
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1 Barnes Jewish Hospital Plaza
St. Louis, Missouri 63110
(314) 747-3000
Principal Investigator: Alan Zajarias, M.D.
Barnes Jewish Hospital Barnes-Jewish Hospital at Washington University Medical Center is the largest hospital in...
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St. Louis, MO
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Tallahassee, Florida 32308
Principal Investigator: Shafi Mohamed, M.D.
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Tallahassee, FL
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Washington, District of Columbia 20010
Principal Investigator: Augusto Pichard, M.D.
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Washington,
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Wormleysburg, Pennsylvania 17043
Principal Investigator: Brijeshwar Maini, M.D.
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Wormleysburg, PA
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