ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:9/23/2018
Start Date:December 2012
End Date:February 2026

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ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)

The objective of this trial is to confirm that the modifications to tissue processing, valve
sterilization and packaging do not raise any new questions of safety and effectiveness in
subjects who require replacement of their native or prosthetic aortic or mitral valve.

Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve
replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement
(MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include
male and female patients, 18 years or older, requiring replacement for a diseased, damaged,
or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and
assessed after implant for up to 5 years.

Eligibility Criteria:

Inclusion Criteria:

1. Is 18 years or older

2. Provides written informed consent prior to trial procedures

3. Agrees to attend all follow-up assessments for up to 5 years and is willing to comply
with specified follow-up evaluations at clinical investigational sites that are
participating in the COMMENCE trial and/or obtain the protocol-specified diagnostic
tests at centers that are under the same IRB or the same healthcare system

4. Diagnosed with aortic or mitral valve disease requiring valve replacement based on
pre- operative evaluation

5. Scheduled to undergo planned aortic or mitral valve replacement with or without
concomitant bypass surgery

6. Scheduled to undergo planned aortic valve replacement with or without resection and
replacement of the ascending aorta from the sinotubular junction and without the need
for circulatory arrest for hemi arch or arch replacement

Exclusion criteria:

A subject meeting any of the following criteria shall be excluded:

1. Requires emergency surgery

2. Requires planned multiple valve replacement/ repair (with the exception of mitral
valve replacement with tricuspid valve repair)

3. Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical
valve, or annuloplasty ring that will remain in situ

4. Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)

5. Requires surgical replacement of the aortic root

6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the
scheduled aortic or mitral valve replacement surgery

7. Has renal insufficiency as determined by creatinine (S-Cr) level ≥ 2.5 mg/dL or end
-stage renal disease requiring chronic dialysis at screening visit

8. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient
ischemic attack (TIA) within 6 months (180 days) prior to planned valve surgery

9. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery

10. Has presence of non-cardiac disease limiting life expectancy to less than 12 months

11. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)

12. Diagnosed with abnormal calcium metabolism and hyperparathyroidism

13. Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure
prior to planned valve surgery

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

15. Hemodynamic or respiratory instability requiring inotropic support, mechanical
circulatory support, or mechanical ventilation within 30 days prior to planned valve
surgery

16. Documented leukopenia (WBC < 3.5x 10³/μL), acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L)
or thrombocytopenia (platelet count < 50x 10³/μL) accompanied by history of bleeding
diathesis and coagulopathy

17. Has prior organ transplant or is currently an organ transplant candidate

18. Current or recent participation (within 6 weeks prior to surgery) in another drug or
device trial

19. Was previously implanted with trial device (Model 11000A or Model 11000M)

20. Pregnant (female subject of childbearing potential only), lactating or planning to
become pregnant during the duration of participation in trial

21. Currently incarcerated or unable to give voluntary informed consent

22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior
to implant

23. Requires concomitant left ventricular assist device (LVAD) placement
We found this trial at
33
sites
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Joseph Bavaria, MD
Phone: 215-662-6841
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Todd K Rosengart, MD
Phone: 832-355-9942
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Vaughn Starnes, MD, PhD
Phone: 323-442-6225
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Michael Halkos, MD, FACS, FACC
Phone: 404-686-3374
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, GA
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
Principal Investigator: James S Gammie, MD
Phone: 410-328-9409
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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Birmingham, Alabama 35211
Principal Investigator: Clifton Lewis, MD
Phone: 205-780-4330
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Birmingham, AL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Douglas R Johnston, MD
Phone: 216-444-7753
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: Jefferson Lyons, MD
Phone: 614-566-1253
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Columbus, OH
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Juan Crestanello, MD
Phone: 614-688-7904
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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Gainesville, Florida 32610
Principal Investigator: Charles Klodell, MD
Phone: 352-273-7837
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Grand Rapids, Michigan 49503
Principal Investigator: Tomasz A Timek, MD
Phone: 616-267-1813
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Harrisburg, Pennsylvania 17110
Principal Investigator: Mubashir Mumtaz, MD
Phone: 717-731-0101
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2002 Holcombe Blvd
Houston, Texas 77030
(713) 791-1414
Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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Indianapolis, Indiana 46290
Principal Investigator: David A Heimansohn, MD
Phone: 317-583-7804
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Louisville, KY
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Nashville, Tennessee 37205
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New Haven, Connecticut 06519
Principal Investigator: Sabet Hashim, MD
Phone: 203-737-8871
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New Haven, CT
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New York, New York 10003
Principal Investigator: John Puskas, MD
Phone: 212-844-1456
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New York, New York 10065
Principal Investigator: Leonard Girardi, MD
Phone: 212-746-5594
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: David Adams, MD
Phone: 212-241-8905
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, New York 10032
Principal Investigator: Hiroo Takayama, MD
Phone: 212-342-0261
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Principal Investigator: Antone Tatooles, MD
Phone: 708-346-4044
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Oak Lawn, IL
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Oklahoma City, Oklahoma 73120
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Oklahoma City, OK
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Kevin Accola, MD
Phone: 407-303-7556
Florida Hospital Florida Hospital is one of the country
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Plano, TX
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Quebec,
Principal Investigator: Francois Francois Dagenais, MD
Phone: 418-656-4617
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Quebec,
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Sacramento, California 95815
Principal Investigator: James Longoria, MD
Phone: 916-733-6008
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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Saint Louis, Missouri 63110
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Stanford, California 94305
Principal Investigator: D Craig Miller, MD
Phone: 650-498-1232
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Tupelo, Mississippi 38801
Principal Investigator: David Talton, MD
Phone: 662-377-7572
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