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 June 2015 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01757665
First received: December 18, 2012
Last updated: June 29, 2015
Last verified: June 2015
  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 Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Safety Endpoints [ Time Frame: WWhen 800 patient years for the aortic valve position and 400 patient years for the mitral position have been achieved ] [ 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 (NYHA) 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: 1025
Study Start Date: December 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2016 (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:

Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to three hundred twenty-five (325) 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

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

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 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
  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

  Show 30 Study Locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: John Puskas, MD Icahn School of Medicine at Mount Sinai
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: June 29, 2015
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
Mitral Valve Insufficiency
Mitral Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on August 26, 2015