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

Description

ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis, Model 11000A With a New Tissue Treatment Platform. The objective of this trial is to confirm that the modifications to tissue processing and valve sterilization do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic valve.

Study Start Date

December 2012

Estimated Completion Date

December 2020

Interventions

  • Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
  • Device: Edwards Aortic Bioprosthesis Model 11000A Valve

Specialties

  • Cardiology: Cardiac Surgery,Valvular Disease
  • Surgery: Cardiac Surgery

MeSH Terms

  • Aortic Valve Insufficiency
  • Aortic Valve Stenosis
  • Edwards Pericardial Bioprostheses

Study ID

Edwards Lifesciences -- 2012-02

Status

Recruiting

Trial ID

NCT01757665

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

1025

Sponsor

Edwards Lifesciences

Inclusion Criteria

    1. Male or female, age 18 years or older 2. Provides written informed consent prior to trial procedures 3. Diagnosed with aortic valve disease requiring a planned replacement as indicated in the preoperative evaluation 4. Scheduled to undergo planned aortic valve replacement with or without concomitant bypass surgery 5. Geographically stable and agrees to attend all follow-up assessments at the hospital of sur-gical services for up to 5 years

Exclusion Criteria

    1. Requires emergency surgery 2. Has prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ 3. Requires multiple valve replacement/repair 4. Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass) 5. Has aneurysm of the aortic root and/or ascending aorta requiring surgical intervention 6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic valve replacement (AVR) 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 AVR surgery 9. Has acute myocardial infarction (MI) within 30 days prior to AVR 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 hyperparathyroidism 13. Exhibits left ventricular ejection fraction ? 30% as validated by diagnostic procedure within 30 days prior to AVR 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 60 days prior to AVR surgery 16. Documented leukopenia (WBC < 3.5x 103/µL), acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), thrombocytopenia (platelet count < 50x103/µL) or history of bleeding diathesis or coagulopathy 17. Diagnosed with myxomatous disease/connective tissue disorders (e.g. Marfan's Syndrome) 18. Has prior organ transplant 19. Current or recent participation (within 6 weeks prior to surgery) in another investigational drug or device trial 20. Was previously implanted with trial device 21. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial 22. Currently incarcerated or unable to give voluntary informed consent 23. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant -

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (30)

Study Location Distance Name Phone Email
YaleNew Haven - New Haven, Connecticut 17.3 miles Lynn Wilson RN 203-737-8871 Lynn.Wilson@ynhh.org
New York Presbyterian Hospital Columbia University Medical Center - New York, New York 44.8 miles Lyn Goldsmith MA RN BSN CCRC 212-342-0261 lg2240@columbia.edu
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles Michael Fusilero 212-241-8905 michael.fusilero@mountsinai.org
New York Weill Cornell Medical Center - New York, New York 48.5 miles Renee Kahn RN 212-746-5594 rek9015@med.cornell.edu
Mount Sinai Beth Israel - New York, New York 51.3 miles Stella Palencia 212-844-1456 spalencia@chpnet.org
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 146.7 miles Tina Matlawski 215-662-6841 tina.matlawski@uphs.upenn.edu
Pinnacle Health Cardiovascular Institute - Harrisburg, Pennsylvania 202.0 miles Regina G Rice Hollister RN 717-731-0101 rhollister@pinnaclehealth.org
University of Maryland School of Medicine - Baltimore, Maryland 222.5 miles Robert Villanueva MPA 410-328-9409 rvillanueva@smail.umaryland.edu
Cleveland Clinic Foundation - Cleveland, Ohio 435.4 miles Michelle Garcia RNBSN 216-444-7753 GARCIAM1@ccf.org
The Ohio State University Wexner Medical Center - Columbus, Ohio 520.3 miles Asia McDavid MS 614-688-7904 asia.mcdavid@osumc.edu
OhioHealth Research Institute - Columbus, Ohio 525.7 miles Carol Strausbaugh BSNRNCCRC 614-566-1253 Carol.strausbaugh@ohiohealth.com
Spectrum Health Hospital - Grand Rapids, Michigan 648.5 miles Mary Ragagni RN 616-267-1813 mary.ragagni@spectrumhealth.org
St Vincent Medical Group - Indianapolis, Indiana 687.0 miles Lisa Barnett RN 317-583-7804 lbarnett@corvascmds.com
University of Louisville Jewish Hospital - Louisville, Kentucky 696.1 miles Anne Marie Webb RN 502-587-4106 anne.webb@louisville.edu
Advocate Christ Medical Center - Oak Lawn, Illinois 782.0 miles Mary Jane Borg RN 708-346-4044 mborg@ctvsurgeons.com
Emory University Hospital Midtown - Atlanta, Georgia 798.9 miles Kim Baio MSN 404-686-3374 kbaio@emory.edu
Cardiology PC - Birmingham, Alabama 919.9 miles Kris Armstrong 205-780-4330 KArmstrong@cardiologypc.com
Missouri Baptist Medical Center - St. Louis, Missouri 946.2 miles None None None
Shands at the University of Florida - Gainesville, Florida 951.0 miles Jessica Cobb PhD 352-273-7837 jessica.cobb@surgery.ufl.edu
North Mississippi Medical Center - Tupelo, Mississippi 974.6 miles Kristin Eads RN 662-377-7572 KEads@nmhs.net
Florida Hospital - Orlando, Florida 989.4 miles Tracey Purvis RN 407-303-7556 BTracey.Purvis@flhosp.org
University of Kansas Medical Center - Kansas City, Kansas 1,138.2 miles None None None
Oklahoma Heart Hospital - Oklahoma City, Oklahoma 1,369.4 miles None None None
Cardiopulmonary Research Science and Technology Institute - Plano, Texas 1,413.1 miles None None None
Baylor College of Medicine - Houston, Texas 1,475.7 miles Laurie Fondren 832-355-9942 fondren@bcm.edu
Michael E DeBakey VA Medical Center - Houston, Texas 1,475.7 miles None None None
University of Utah - Salt Lake City, Utah 2,001.2 miles None None None
University of Southern California - Los Angeles, California 2,487.5 miles Leticia VasquezCaldera RN 323-442-6225 leticia.vasquez-caldera@med.usc.edu
Sutter Memorial Hospital - Sacramento, California 2,506.0 miles Kristen Lawton RN 916-733-6008 LawtonKJ@sutterhealth.org
Board of Trustees of the Leland Stanford Junior University - Stanford, California 2,599.9 miles Kokil Bakshi MSBA 650-498-1232 kbakshi@stanford.edu

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