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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01757665
First received: December 18, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Aortic Stenosis
Mitral Stenosis
Aortic Valve Insufficiency
Mitral Valve Insufficiency
Heart Failure
Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of the Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Safety Endpoints [ Time Frame: When 400 patient years for each valve position has been achieved - approx. December 2016 ] [ Designated as safety issue: Yes ]

    Descriptive information of early rates and late linearized rates of:

    • Structural valve deterioration
    • Thromboembolism
    • Valve thrombosis
    • All bleeding/hemorrhage
    • Major bleeding/hemorrhage
    • All paravalvular leak
    • Major paravalvular leak
    • Non-structural valve deterioration
    • Endocarditis
    • All cause mortality
    • Trial valve-related mortality
    • Trial valve-related reoperation
    • Explant
    • Hemolysis


Secondary Outcome Measures:
  • Effectiveness Endpoints [ Time Frame: Up to 5-Years at each scheduled follow-up visit ] [ Designated as safety issue: No ]
    • Clinically acceptable hemodynamic performance confirmed by core lab evaluation of echocardiography
    • New York Heart Association (NY-HA) functional class compared to baseline
    • Change in Quality of Life questionnaire Short Form 12 version 2 (SF-12v2) from baseline/screening to POD 390


Estimated Enrollment: 650
Study Start Date: December 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M
Aortic/Mitral valve replacement therapy
Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M

Detailed Description:

This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 650 subjects will be enrolled at up to 35 participating clinical sites. 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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:

  1. Requires emergency surgery
  2. Requires multiple valve replacement/ 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 mgdL 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/or 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), thrombocytopenia (platelet count < 50x103/µL) or history of bleeding diathesis or 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757665

Contacts
Contact: Bruce Van Deman 949-250-2626 bruce_van_deman@ewards.com
Contact: Gita Ghadimi, OD 949-250-5872 gita_ghadimi@edwards.com

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Leticia Vasquez-Caldera, RN    323-442-6225    leticia.vasquez-caldera@med.usc.edu   
Principal Investigator: Vaughn Starnes, MD, PhD         
United States, Florida
Shands at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Debra Robertson, RN    352-273-5510    Debra.Robertson@surgery.ufl.edu   
Contact: Charles Klodell, MD    352-273-5501    charles.klodell@surgery.ufl.edu   
Principal Investigator: Charles Klodell, MD         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Beverly Mansker, RN    407-303-7556    Beverly.Mansker@flhosp.org   
Contact: Tracey Purvis, RN    407-303-7556    Tracey.Purvis@flhosp.org   
Principal Investigator: Kevin Accola, MD         
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Kim Baio, MSN    404-686-3374    kbaio@emory.edu   
Contact: Alexis Neill, RN    404-686-3575    alexis.neill@emory.eduedu   
Principal Investigator: Michael Halkos, MD, FACS, FACC         
United States, Indiana
St. Vincent Medical Group Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Lisa Barnett, RN    317-583-7804    lbarnett@corvascmds.com   
Contact: Andrew Scroggs, Research Director    317-338-9380    RASCROGG@stvincent.org   
Principal Investigator: David A Heimansohn, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Susie Page, RN    913-588-9720    spage3@kumc.edu   
Contact: Dominique Dziedzic    913-945-6445    ddziedzic@kumc.edu   
Principal Investigator: George "Trip" Zorn, MD         
United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: Robert Villanueva, MPA    410-328-9409    rvillanueva@smail.umaryland.edu   
Contact: Cindi Young, RN    410-328-8149    cyoung@smail.umaryland.edu   
Principal Investigator: James S Gammie, MD         
United States, Michigan
Spectrum Health Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Jeanine Holen, RN    616-391-5067    jeanine.holen@spectrum-health.org   
Contact: Julie Bishop, RN    616-391-2727    julie.bishop@spectrumhealth.org   
Principal Investigator: Tomasz A Timek, MD         
United States, New York
New York Presbyterian Hospital - Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Lyn Goldsmith, MA RN BSN CCRC    212-342-0261    lg2240@columbia.edu   
Contact: Amanda Alonso, CCRC    212-342-4539    aa2974@columbia.edu   
Principal Investigator: Hiroo Takayama, MD         
New York Weill Cornell Medical Center Recruiting
New York, New York, United States, 10021
Contact: Renee Kahn, RN    212-746-5594    rek9015@med.cornell.edu   
Contact: Kim O'Brien    212-746-5194    kmk9002@med.cornell.edu   
Principal Investigator: Leonard Girardi, MD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Ya-El Mandel-Portnoy, M. Sc    212-241-8905    yael.mandel-Portnoy@mountsinai.org   
Contact: Robin Varghese, MD    212-659-9490    Robin.varghese@mountsinai.org   
Principal Investigator: David Adams, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Michelle Garcia, RN,BSN    216-444-7753    GARCIAM1@ccf.org   
Contact: Carrie Geither, RN, CCRP    216-445-6916    GEITHEC@ccf.org   
Principal Investigator: Lars Svensson, MD, PhD         
United States, Oklahoma
Oklahoma Heart Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73135
Contact: Stacie Hanes, CRC    405-608-1280    shanes@okheart.com   
Contact: Julia Myers, RN    405-628-6288    jmyers@okheart.com   
Principal Investigator: Goya Raikar, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Laurie Fondren    832-355-9942    fondren@bcm.edu   
Contact: Tunu Magwe    713-798-8393    ttenende@bcm.edu   
Principal Investigator: Todd K Rosengart, MD         
Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II Recruiting
Krakow, Poland, 31-202
Contact: Krzysztof Bartus, Dr. Med    +48 5022 94 250    coolchris@interia.pl   
Contact: Maciek Bochenek, Dr. Med    +48 6065 15 870    mbochenek@poczta.fm   
Principal Investigator: Jerzy Sadowski, Prof. Dr. Med         
Instytut Kardiologii im. Prymasa Tysiqclecia Stefana Recruiting
Warsaw, Poland, 04-628
Contact: Agata Bilewska, MD, PhD    +48(22)8154901    agatabilewska@o2.pl   
Contact: Mariusz Kusmierczyk, MD, PhD    +48(22)3434610    mkusmierczyk1971@gmail.com   
Principal Investigator: Jacek Rozanski, MD, PhD         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: John Puskas, MD Emory University Hospital Midtown
Principal Investigator: Lars Svensson, MD,PhD Organizational Affiliation: The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01757665     History of Changes
Other Study ID Numbers: 2012-02
Study First Received: December 18, 2012
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Edwards Lifesciences:
Aortic valve replacement
Mitral valve replacement

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Heart Failure
Mitral Valve Insufficiency
Mitral Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014