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Completed

NCT Number: NCT01757665

ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses 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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Mitral Stenosis Mitral Valve Insufficiency Mitral Valve Stenosis Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria:

Inclusion criteria

  • Is 18 years or older
  • Provides written informed consent prior to trial procedures
  • 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
  • Diagnosed with aortic or mitral valve disease requiring valve replacement based on pre- operative evaluation
  • Scheduled to undergo planned aortic or mitral valve replacement with or without concomitant bypass surgery
  • 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:

  • Requires emergency surgery
  • Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve repair)
  • Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
  • Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
  • Requires surgical replacement of the aortic root
  • Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic or mitral valve replacement surgery
  • 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
  • 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
  • Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery
  • Has presence of non-cardiac disease limiting life expectancy to less than 12 months
  • Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
  • Diagnosed with abnormal calcium metabolism and hyperparathyroidism
  • Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure prior to planned valve surgery
  • Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
  • 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
  • Has prior organ transplant or is currently an organ transplant candidate
  • Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
  • Was previously implanted with trial device (Model 11000A or Model 11000M)
  • Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial
  • Currently incarcerated or unable to give voluntary informed consent
  • Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
  • Requires concomitant left ventricular assist device (LVAD) placement

Treatment and study plan

Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

Device

Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study 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)

Acronym: COMMENCE

Important dates

Study start
2012
Primary completion
2017
Study completion
2026
First posted
Dec 31, 2012
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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