PERIGON Pivotal Trial



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:May 12, 2014
End Date:July 27, 2022
Contact:Ryan Palmer
Email:ryan.j.palmer@medtronic.com
Phone:(763) 514-9732

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Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

This is a prospective, interventional, non-randomized, worldwide, multi-center trial, with
each site following a common protocol. A maximum of 1300 subjects will be implanted at a
maximum of 40 sites in the US, Europe and Canada. The trial will include male and female
patients of legal age to provide informed consent in the country where they enroll in the
trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic
aortic valve. Patients will be followed and assessed after implant for up to 5 years.

Inclusion Criteria:

1. Patient has moderate or greater aortic stenosis or regurgitation, and there is
clinical indication for replacement of their native or prosthetic aortic valve with a
bioprosthesis, with or without concomitant procedures, which are limited to any of the
following:

i. LAA ligation ii. CABG iii. PFO closure iv. Ascending aortic aneurysm or dissection
repair not requiring circulatory arrest v. Resection of a sub-aortic membrane not
requiring myectomy

2. Patient is geographically stable and willing to return to the implanting site for all
follow-up visits

3. Patient is of legal age to provide informed consent in the country where they enroll
in the trial

4. Patient has been adequately informed of risks and requirements of the trial and is
willing and able to provide informed consent for participation in the clinical trial

Exclusion Criteria:

1. Patient has a pre-existing prosthetic valve or annuloplasty device in another position
or requires replacement or repair of the mitral, pulmonary or tricuspid valve

2. Patient has had previous implant and then explant of the Model 400 aortic valve
bioprosthesis

3. Patient presents with active endocarditis, active myocarditis or other systemic
infection

4. Patient has an anatomical abnormality which would increase surgical risk of morbidity
or mortality, including:

- Ascending aortic aneurysm or dissection repair requiring circulatory arrest

- Acute Type A aortic dissection

- Ventricular aneurysm

- Porcelain aorta

- Hostile mediastinum

- Hypertrophic obstructive cardiomyopathy (HOCM)

- Documented pulmonary hypertension (systolic >60mmHg)

5. Patient has a non-cardiac major or progressive disease, with a life expectancy of less
than 2 years. These conditions include, but are not limited to:

- Child-Pugh Class C liver disease

- Terminal cancer

- End-stage lung disease

6. Patient has renal failure, defined as dialysis therapy or GFR<30 mL/min/1.73 m2

7. Patient has hyperparathyroidism

8. Patient is participating in another investigational device or drug trial or
observational competitive study

9. Patient is pregnant, lactating or planning to become pregnant during the trial period

10. Patient has a documented history of substance (drug or alcohol) abuse

11. Patient has greater than mild mitral valve regurgitation or greater than mild
tricuspid valve regurgitation as assessed by echocardiography

12. Patient has systolic EF<20% as assessed by echocardiography

13. Patient has Grade IV Diastolic Dysfunction

14. Patient has documented bleeding diatheses

15. Patient has had an acute preoperative neurological deficit or myocardial infarction
and has not returned to baseline or stabilized ≥30 days prior to enrollment

16. Patient requires emergency surgery
We found this trial at
21
sites
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: David Fullerton, MD
Phone: 303-724-2757
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Thoralf Sundt, MD
Phone: 617-762-6759
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Gosta Pettersson, MD
Phone: 216-445-4337
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Gainesville, Florida 32611
Principal Investigator: Thomas Beaver, MD
Phone: 352-273-5510
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Gainesville, FL
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: David Adams, MD
Phone: 212-241-0029
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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Ann Arbor, Michigan 48109
Principal Investigator: Himanshu Patel, MD
Phone: (734) 232-6737
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Ann Arbor, MI
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Principal Investigator: Morris Brown, MD
Phone: 404-605-2327
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Atlanta, GA
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1010 West 40th Street
Austin, Texas 78756
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Austin, TX
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: James Gammie, MD
Phone: 410-328-2737
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Principal Investigator: Gregory Ribakove, MD
Phone: 718-283-7709
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Brooklyn, NY
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Columbus, Ohio 43214
Principal Investigator: Steven Duff, MD
Phone: 614-566-1262
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Columbus, OH
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Michael Reardon, MD
Phone: 713-441-3905
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Houston, TX
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339 Windermere Road
London, Ontario N6A 5A5
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London,
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Los Angeles, CA
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Milwaukee, Wisconsin 53215
Principal Investigator: David Kress, MD
Phone: 414-385-2504
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Milwaukee, WI
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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New York, New York 10032
Principal Investigator: Michael Borger, MD
Phone: 212-305-3009
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New York, NY
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Oklahoma City, Oklahoma 73120
Principal Investigator: Goya Raikar, MD
Phone: 405-628-6288
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Oklahoma City, OK
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Gabriel Aldea, MD
Phone: 206-221-7833
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Seattle, WA
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Stanford, California 94305
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Stanford, CA
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Toledo, Ohio 43606
Principal Investigator: Michael Moront, MD
Phone: 419-291-2373
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Toledo, OH
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