Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:September 2012
End Date:November 2021

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Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent

The purpose of the clinical study is to prove that the heart valve device is safe, effective,
and performs as intended.

This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be
enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with
the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the
following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of
five years.

Inclusion Criteria:

- Inclusion Criteria - Subjects will be required to meet all inclusion criteria:

1. Male or female, age 18 years or older

2. Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a
planned replace-ment as indicated in the preoperative evaluation

3. Is scheduled to undergo planned aortic valve replacement with or without
concomitant coronary bypass surgery

4. Provide written informed consent

5. Geographically stable and agrees to attend follow-up assessments until all
subjects have completed 5 years of follow up

Exclusion Criteria:

- Exclusion Criteria - Subjects will not be eligible for trial participation if any of
the following criteria are present:

1. Pure aortic insufficiency

2. Requires emergency surgery

3. Previous aortic valve replacement

4. Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of
a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in
situ

5. Requires multiple valve replacement/repair

6. Requires a surgical procedure outside of the cardiac area (e.g., vascular
endarterectomy, vascular bypass, tumor removal)

7. Aneurysm of the aortic root and/or ascending aorta requiring surgical
intervention

8. Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months
prior to the scheduled AVR surgery

9. Myocardial infarction (MI) within thirty (30) days prior to valve replacement
surgery

10. Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or
end-stage renal disease requiring chronic dialysis

11. Hyperparathyroidism

12. MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic
attack (TIA) within 6 months (180 days) of the procedure

13. Presence of non-cardiac disease limiting life expectancy to less than 12 months

14. Hypertrophic obstructive cardiomyopathy (HOCM)

15. Left ventricular ejection fraction ≤ 25%

16. Documented history of substance (drug or alcohol) abuse within the last 5 years

17. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation

18. Hemodynamic or respiratory instability requiring inotropic support, mechanical
circulatory support, or mechanical ventilation within 30 days prior to the
procedure

19. Pregnancy, lactation, or planning to become pregnant;

20. Currently incarcerated or unable to give voluntary informed consent

21. Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L),
or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding
diathesis or coagulopathy

22. History of myxomatous disease/connective tissue disorders (e.g., Marfan's
Syndrome)

23. Current or recent participation (within 6 weeks prior to surgery) in an
investigational drug or device trial

_____

Intra-operative Exclusion Criteria

24. Anatomic variances which contraindicate implant of the trial valve, such as:

1. anomalous coronary arteries

2. annular deformation or extensive calcification of the annulus or aortic root
which cannot be removed

3. significant calcium on the anterior mitral leaflet

4. pronounced septal calcification

5. position of coronary ostia relative to Model 8300ACD valve that would result
in obstruction of blood flow

25. Available devices are not suitably sized for the subject's annulus
We found this trial at
29
sites
Asheville, North Carolina 28801
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Michael A Borger, MD, PhD
Phone: 212-342-4539
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Ann Arbor, Michigan 48109
Principal Investigator: Himanshu J Patel, MD
Phone: 734-232-4780
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Patrick McCarthy, MD
Phone: 312-695-4067
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Cincinnati, Ohio 45220
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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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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...
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Harrisburg, Pennsylvania 17011
Principal Investigator: Mubashir Mumtaz, MD
Phone: 717-731-0101
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Memphis, Tennessee 38120
Principal Investigator: H Edward Garrett Jr., MD
Phone: 901-747-1262
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Nashville, Tennessee 37205
Principal Investigator: Evelio Rodriguez, MD
Phone: 615-222-3083
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New York, New York 10021
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Newport Beach, California 92658
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Kevin Accola, MD
Phone: 407-303-5600
Florida Hospital Florida Hospital is one of the country
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Palo Alto, California 94304
Principal Investigator: Y. Joseph Woo, MD
Phone: 650-498-1232
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Plano, Texas 75093
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Sacramento, California 95819
Principal Investigator: Allen Morris, MD
Phone: 916-453-4161
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Saint Louis, Missouri 63110
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Glenn R Barnhart, MD
Phone: 206-215-2455
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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