Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01757665
Recruitment Status : Active, not recruiting
First Posted : December 31, 2012
Results First Posted : December 27, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
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 or disease Intervention/treatment Phase
Aortic Stenosis Mitral Stenosis Aortic Valve Insufficiency Mitral Valve Insufficiency Heart Failure Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 777 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : December 2012
Actual Primary Completion Date : August 2017
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Subjects With Structural Valve Deterioration [ Time Frame: 1 Year Post Implant ]
    The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow‐up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.


Secondary Outcome Measures :
  1. Percentage of Subjects With Early Adverse Events [ Time Frame: Events occuring within 30 days of procedure ]
    Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100

  2. Percentage of Late Adverse Events Divided by Late Patient Years [ Time Frame: Events occurring >= 31 days and up through 3 years post-implant ]
    Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).


Other Outcome Measures:
  1. Subject's Average Mean Gradient Measurements - 11000A [ Time Frame: 3 Months, 1 Year, and 2 Year Post Implant ]
    Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

  2. Subject's Average Mean Gradient Measurements - 11000M [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

  3. Subject's Average Peak Gradients Measurements Over Time - 11000A [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.

  4. Subject's Average Peak Gradients Measurements Over Time - 11000M [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.

  5. Subject's Average Effective Orifice Area Measurements - 11000A [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.

  6. Subject's Average Effective Orifice Area Measurements - 11000M [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.

  7. Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.

  8. Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.

  9. Subject's Average Performance Index Measurements - 11000A [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.

  10. Subject's Average Performance Index Measurements - 11000M [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Performance index is defined as the subject's effective orifice area (the crosssectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.

  11. Subject's Average Cardiac Output Over Time - 11000A [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    The amount of blood the heart pumps through the circulatory system in a minute.

  12. Subject's Average Cardiac Output Over Time - 11000M [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    The amount of blood the heart pumps through the circulatory system in a minute.

  13. Subject's Average Cardiac Index Over Time- 11000A [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual.

  14. Subject's Average Cardiac Index Over Time - 11000M [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area(BSA), thus relating heart performance to the size of the individual.

  15. Subject's Amount of Total Valvular Regurgitation Over Time - 11000A [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

  16. Subject's Amount of Total Valvular Regurgitation Over Time - 11000M [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]
    Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

  17. Subject's Amount of Paravalvular Leak Over Time - 11000A [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]

    Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.

    Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.


  18. Subject's Amount of Paravalvular Leak Over Time - 11000M [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]

    Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.

    Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.


  19. Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline [ Time Frame: 3 Months, 1 Year, and 2 Years Post Implant ]

    The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

    Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

    Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

    Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.


  20. Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey [ Time Frame: Baseline and one year post-implant ]

    The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

    The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.

    The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.


  21. Subject's Average White Blood Cell Count [ Time Frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year ]
    Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection.

  22. Subject's Average Red Blood Cells Count [ Time Frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year ]
    Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.

  23. Subject's Average Hematocrit Percentage [ Time Frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year ]
    Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood).

  24. Subject's Average Hemoglobin Count [ Time Frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year ]
    Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

  25. Subject's Average Platelet Count [ Time Frame: Baseline, Discharge, 3 Months, 1 Year, and 2 Years ]
    Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

  26. Subject's Average Plasma Free Hemoglobin [ Time Frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year ]
    Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood).

  27. Subject's Average International Normalized Ratio [ Time Frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year ]
    Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot. INR results will vary according to a person's age, the medicines they take, and any health problems they may have. In general, the higher the INR number, the longer it takes for the blood to clot. In healthy people an INR of 1.1 or below is considered normal. An INR range of 2.0 to 3.0 is generally an effective therapeutic range for people taking blood thinner medication.

  28. Subject's Average Partial Thromboplastin Time [ Time Frame: Baseline, Discharge, 3 Months, 1 Year and 2 Year ]
    Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot.

  29. Subject's Average Prothrombin Time [ Time Frame: Baseline, Discharge, 3 Months, 1 Year, and 2 Years ]
    Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot.

  30. Subjects Average Serum Glycerol Levels [ Time Frame: Pre-Implant (post-heparinization) and Post-Implant (between 60 and 120 minutes after heart was restarted) ]
    Laboratory analysis of serum glycerol in blood drawn from subjects. This blood test measures the amount of glycerol (a naturally occurring carbohydrate, that can be used as a fuel source by the body) in the serum (liquid portion of the blood).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757665


Locations
Show Show 32 study locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Layout table for investigator information
Principal Investigator: John Puskas, MD Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

Documents provided by Edwards Lifesciences:
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01757665    
Other Study ID Numbers: 2012-02
First Posted: December 31, 2012    Key Record Dates
Results First Posted: December 27, 2019
Last Update Posted: February 5, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Edwards Lifesciences:
Aortic valve replacement
Mitral valve replacement
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Mitral Valve Insufficiency
Aortic Valve Insufficiency
Mitral Valve Stenosis
Constriction, Pathologic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Heart Valve Diseases
Ventricular Outflow Obstruction