The PARTNER II Trial: S3iCAP



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:January 2015
End Date:August 2026

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The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (S3iCAP)

The purpose of this trial is to determine the safety and effectiveness of the Edwards Edwards
SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in
patients with symptomatic, calcific, severe aortic stenosis.

This multi-center, single arm registry will provide continued access of the Edwards SAPIEN 3
Transcatheter Heart Valve and delivery systems to severe aortic stenosis patients at
intermediate risk for standard aortic valve replacement. Patient data will be entered into
the TVT Registry (TVTR) from screening through 1 year including the collection of 5 year
follow-up through CMS.

Inclusion Criteria:

1. Patients must be covered by Medicare. This will enable Edwards to link to the CMS
database for long term follow-up through 5 years. No other insurance provider will be
accepted.

2. Assessment of intermediate surgical risk defined as STS 4-8% or heart team assessment
of intermediate risk factors.

3. Patient has senile degenerative aortic valve stenosis with echocardiographically
derived criteria: mean gradient > 40 mmHg or jet velocity greater than 4.0 m/s and an
initial aortic valve area (AVA) of < 0.8 cm2 or indexed EOA < 0.5 cm2/m2. Qualifying
echo must be within 60 days of the date of the procedure.

4. Aortic valve annulus area range (273mm2-680 mm2) per 3D imaging (echo, CT, or MRI).

5. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA
Functional Class II or greater.

6. The heart team agrees (and verified in the case review process) that valve
implantation will likely benefit the patient.

7. Heart team agrees (a priori) on treatment strategy for concomitant coronary disease
(if present).

8. The study patient or the study patient's legal representative has been informed of the
nature of the study, agrees to its provisions and has provided written informed
consent as approved by the Institutional Review Board (IRB) of the respective clinical
site.

9. The study patient agrees to comply with all required post-procedure follow-up visits
including annual visits through 5 years and analysis close date visits, which will be
conducted as a phone follow-up.

Exclusion Criteria:

1. Heart team assessment of inoperability (including examining cardiac surgeon).

2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended
treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥
twice normal in the presence of MB elevation and/or troponin level elevation (WHO
definition)].

3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is
non-calcified.

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

5. Pre-existing mechanical or bioprosthetic valve in any position.

6. Complex coronary artery disease:

1. Unprotected left main coronary artery

2. Syntax score > 32 (in the absence of prior revascularization)

7. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is
performed within 30 days of the index procedure (unless part of planned strategy for
treatment of concomitant coronary artery disease). Implantation of a permanent
pacemaker or ICD is not considered exclusion criteria.

8. Any patient with a balloon valvuloplasty (BAV) < 30 days of the procedure (unless BAV
is a bridge to procedure after a qualifying ECHO).

9. Patients with planned concomitant surgical or transcatheter ablation for atrial
fibrillation.

10. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt <
50,000 cell/mL).

11. Hypertrophic cardiomyopathy with or without obstruction (HOCM).

12. Hemodynamic or respiratory instability requiring inotropic support, mechanical
ventilation or mechanical heart assistance within 30 days of screening evaluation.

13. Need for emergency surgery for any reason.

14. Severe ventricular dysfunction with LVEF < 20%.

15. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

16. Active upper GI bleeding within 3 months (90 days) prior to procedure.

17. A known contraindication or hypersensitivity to all anticoagulation regimens, or
inability to be anticoagulated for the study procedure.

18. Native aortic annulus size < 16 mm or > 28mm as measured by echocardiogram.

19. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic
attack (TIA) within 6 months (180 days) of the procedure.

20. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the
time of screening.

21. Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver
disease, chronic renal dis-ease or chronic end stage pulmonary disease.

22. Expectation that patient will not improve despite treatment of aortic stenosis.

23. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch
atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing
(especially with calcification and surface irregularities) of the abdominal or
thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta.
(Transfemoral)

24. Iliofemoral vessel characteristics that would preclude safe placement of 14F or 16F
introducer sheath such as severe obstructive calcification, severe tortuosity or
min-imum average vessel size less than 5.5 mm. (Transfem-oral).

25. Currently participating in an investigational drug or an-other device study. Note:
Trials requiring extended fol-low-up for products that were investigational, but have
since become commercially available, are not considered investigational trials.

26. Active bacterial endocarditis within 6 months (180 days) of procedure.

27. Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis.

28. Inability to tolerate anticoagulation/antiplatelet therapy.

29. For transfemoral approach only: Femoro-iliac vessels < 5.5 mm for the 23 mm and the 26
mm system and < 6.0 mm for the 29 mm system.
We found this trial at
56
sites
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Steven Bailey, MD
Phone: 210-567-4601
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Vasilis Babaliaros, MD
Phone: 404-712-0131
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Pinak Shah, MD
Phone: 857-307-1986
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: John Passeri, MD
Phone: 617-643-7022
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Boston, MA
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Principal Investigator: Todd Dewey, MD
Phone: 972-566-7219
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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Dallas, TX
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Charles Klodell, MD
Phone: 352-273-5501
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Richard Smalling, MD
Phone: 713-500-6559
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Raj Makkar, MD
Phone: 310-423-3871
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Larry Dean, MD
Phone: 206-598-8257
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Ann Arbor, Michigan 48109
Principal Investigator: Stanley Chetcuti Chetcuti, MD
Phone: 734-232-4276
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Austin, Texas 78756
Principal Investigator: Faraz Kerendi, MD
Phone: 512-206-3600
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Baltimore, Maryland 21218
Principal Investigator: John Wang, MD
Phone: 410-554-2332
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Anuj Gupta, MD
Phone: 443-602-0522
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Charleston, North Carolina 29425
Principal Investigator: Daniel Steinberg, MD
Phone: 843-876-4787
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Irving Kron Kron, MD
Phone: 434-924-4270
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Clifford Kavinsky, MD
Phone: 312-942-4833
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Chris Malaisrie, MD
Phone: 312-695-2517
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Dean Kereiakes, MD
Phone: 513-585-1777
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Clearwater, Florida 33756
Principal Investigator: Joshua Rovin, MD
Phone: 727-446-2273
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Denver, Colorado 80262
Principal Investigator: John Carroll, MD
Phone: 720-848-6508
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: William O'Neill, MD
Phone: 313-916-1878
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: J. Harrison, MD
Phone: 919-681-3763
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Evanston, Illinois 60201
Principal Investigator: Ted Feldman, MD
Phone: 847-570-2250
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Indianapolis, Indiana 46202
Principal Investigator: Anjan Sinha, MD
Phone: 317-962-0561
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Indianapolis, Indiana 46290
Principal Investigator: James Hermiller, MD
Phone: 317-583-6044
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Phillip Horwitz, MD
Phone: 319-356-3689
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Kansas City, Missouri 64111
Principal Investigator: Adnan Chhatriwalla, MD
Phone: 816-931-1883
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La Jolla, California 92037
Principal Investigator: Paul Teirstein, MD
Phone: 858-554-9905
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: James Devries, MD
Phone: 603-650-6224
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lincoln, Nebraska 68526
Principal Investigator: James Wudel, MD
Phone: 402-489-6555
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Louisville, Kentucky 40202
Principal Investigator: Kendra Grubb, MD
Phone: 502-561-2180
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Giorgio Gimelli, MD
Phone: 608-263-0891
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Memphis, Tennessee 38120
Principal Investigator: H. Edward Garrett, Jr., MD
Phone: 901-747-1262
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: John Goncalves, MD
Phone: 516-663-4400
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Minneapolis, Minnesota 55407
Principal Investigator: Wesley Pedersen, MD
Phone: 612-863-3900
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New Orleans, Louisiana 70121
Principal Investigator: Stephen Ramee, MD
Phone: 504-842-3727
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New York, New York 10021
Principal Investigator: Shing Chiu Wong, MD
Phone: 212-746-4644
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Susheel Kodali, MD
Phone: 646-426-0204
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York 10075
Principal Investigator: S. Scheinerman, MD
Phone: 718-470-7460
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Principal Investigator: Marc Cohen, MD
Phone: 973-926-7852
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Norfolk, Virginia 23507
Principal Investigator: Paul Mahoney, MD
Phone: 757-388-5480
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Oklahoma City, Oklahoma 73120
Principal Investigator: Mark Bodenhamer, MD
Phone: 405-608-3927
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Palo Alto, California 94303
Principal Investigator: Craig Miller, MD
Phone: 650-723-5771
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Joseph Bavaria Bavaria, MD
Phone: 215-662-2017
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Plano, Texas 75093
Principal Investigator: David Brown, MD
Phone: 972-566-7733
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Portland, Oregon 97220
Principal Investigator: Robert Hodson, MD
Phone: 503-962-1000
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Rochester, Minnesota 55905
Principal Investigator: Verghese Mathew, MD
Phone: 507-538-1469
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Royal Oak, Michigan 48073
Principal Investigator: George Hanzel, MD
Phone: 248-898-4163
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Sacramento, California 95819
Principal Investigator: Frank Slachmand, MD
Phone: 916-733-6850
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Saint Louis, Missouri 63110
Principal Investigator: Alan Zajarias, MD
Phone: 314-454-8457
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Salt Lake City, Utah 84157
Principal Investigator: Brian Whisenant, MD
Phone: 801-507-3500
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Springfield, Illinois 62701
Principal Investigator: Gregory Mishkel, MD
Phone: 217-788-0706
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Vancouver, British Columbia
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110 Irving Street Northwest
Washington, District of Columbia 20010
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York, Pennsylvania 17315
Principal Investigator: William Nicholson, MD
Phone: 717-851-2441
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