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Trial record 2 of 3 for:    edwards commence

COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement (COMMENCE-P)

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ClinicalTrials.gov Identifier: NCT02656290
Recruitment Status : Active, not recruiting
First Posted : January 14, 2016
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.

Condition or disease Intervention/treatment Phase
Pulmonary Valve Insufficiency Pulmonary Valve Degeneration Congenital Pulmonary Valve Abnormality Device: Edwards Pericardial Aortic Bioprosthesis Model 11000A Not Applicable

Detailed Description:
This is a prospective, Non-Randomized, Single Arm, Multicenter study. Up to one hundred (100) pulmonary valve replacement (PVR) subjects at up to ten (10) clinical sites will be enrolled. Clinical data will be collected from at least 3 centers with data available on patients who have completed the 1 year follow-up visit. Subjects will be followed for and assessed after implant for up to 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Non‐Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Edwards Pericardial Aortic Bioprosthesis Model 11000A
Pulmonary valve replacement
Device: Edwards Pericardial Aortic Bioprosthesis Model 11000A
Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium




Primary Outcome Measures :
  1. Primary Safety Endpoint [ Time Frame: 1 year ]
    Freedom from device or procedure related death and/or reoperation at 1 year


Secondary Outcome Measures :
  1. Early Adverse Events [ Time Frame: 30 days ]
    1) All cause mortality, 2) All/Major paravalvular leak, 3) All/Major transvalvular leak, 4) Endocarditis, 5) Explant, 6) Thromboembolism, 7) Valve-related reoperation, 8) Structural valve deterioration, 9) Non-structural valve deterioration, 10) Trial valve-related mortality, 11) Valve thrombosis, 12) All/Major valve-related bleeding, 13) Hemolysis

  2. Late Adverse Events [ Time Frame: 6 months, and annually for up to 5 years ]
    1) All cause mortality, 2) All/Major paravalvular leak, 3) All/Major transvalvular leak, 4) Endocarditis, 5) Explant, 6) Thromboembolism, 7) Valve-related reoperation, 8) Structural valve deterioration, 9) Non-structural valve deterioration, 10) Trial valve-related mortality, 11) Valve thrombosis, 12) All/Major valve-related bleeding, 13) Hemolysis

  3. Subject's Average Mean Gradient [ Time Frame: Baseline, 6 months, and annually thereafter for up to 5 years ]
    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.

  4. Subject's Average Peak Gradients [ Time Frame: Baseline, 6 months, and annually thereafter for up to 5 years ]
    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.

  5. Subject's Amount of Valvular Regurgitation [ Time Frame: Baseline, 6 months, and annually thereafter for up to 5 years ]
    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.

  6. TR gradient [ Time Frame: Baseline, 6 months, and annually thereafter for up to 5 years ]
    Tricuspid regurgitation (TR) gradient (peak systolic) is defined as the maximum value measured of blood flowing back through the tricuspid valve during systole as measured in millimeters of mercury.

  7. Peak Velocity [ Time Frame: Baseline, 6 months, and annually thereafter for up to 5 years ]
    Peak velocity is defined as the maximum speed in meters per second that the blood is flowing through the pulmonic heart valve in a given direction.

  8. Doppler Velocity Index (DVI) [ Time Frame: Baseline, 6 months, and annually thereafter for up to 5 years ]
    The Doppler Velocity Index (DVI) is a calculation of the ratio of the subvalvular velocity obtained by pulse wave Doppler and the maximum velocity obtained by continuous wave Doppler across the prosthetic valve.

  9. Transvalvular VTI [ Time Frame: Baseline, 6 months, and annually thereafter for up to 5 years ]
    Tricuspid valvular regurgitation velocity time interval (VTI) is defined as the measurement in centimeters of the blood flowing backwards through the tricuspid valve, averaged over time.

  10. Subject's New York Heart Association (NYHA) Functional Class for subjects older than 12 years [ Time Frame: Baseline, 30 days, 6 months, and annually thereafter for up to 5 years ]

    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.


  11. Cross-tabulation of New York Heart Association (NYHA) Functional Class for subjects older than 12 years [ Time Frame: Baseline and 1 Year ]

    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.


  12. Modified Ross Heart Failure Classification for subjects 12 years and under [ Time Frame: Baseline, 30 days, 6 months, and annually for up to 5 years ]

    The Modified Ross Heart Failure classification system relates symptoms to everyday activities and the adolescent patient's quality of life.

    Class I. No limitations or symptoms

    Class II. Infants: Mild tachypnea or diaphoresis with feeding Older children: Mild to moderate dyspnea on exertion

    Class III. Infants: Growth failure and marked tachypnea or diaphoresis with feeding Older children: Marked dyspnea on exertion

    Class IV. Symptoms at rest such as tachypnea, retractions, grunting, or diaphoresis


  13. Cross-tabulation of Modified Ross Heart Failure Classification for subjects 12 years and under [ Time Frame: Baseline and 1 Year ]

    The Modified Ross Heart Failure classification system relates symptoms to everyday activities and the adolescent patient's quality of life.

    Class I. No limitations or symptoms

    Class II. Infants: Mild tachypnea or diaphoresis with feeding Older children: Mild to moderate dyspnea on exertion

    Class III. Infants: Growth failure and marked tachypnea or diaphoresis with feeding Older children: Marked dyspnea on exertion

    Class IV. Symptoms at rest such as tachypnea, retractions, grunting, or diaphoresis



Other Outcome Measures:
  1. Subject's Average White Blood Cell Count [ Time Frame: Baseline, 6 months, and annually for up to 5 years ]
    Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.

  2. Subject's Average Red Blood Cells Count [ Time Frame: Baseline, 6 months, and annually for up to 5 years ]
    Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.

  3. Subject's Average Hemoglobin Count [ Time Frame: Baseline, 30 days, 6 months, and annually for up to 5 years ]
    Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

  4. Subject's Average Hematocrit Percentage [ Time Frame: Baseline, 6 months, and annually for up to 5 years ]
    Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component(plasma) in the blood.

  5. Subject's Average Platelet Count [ Time Frame: Baseline, 6 months, and annually for up to 5 years ]
    Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

  6. Subject's Average plasma free hemoglobin or haptoglobin or serum LDH [ Time Frame: Baseline, 6 months, and annually for up to 5 years ]

    Laboratory Analysis on blood drawn from subjects. Plasma free hemoglobin test measures the level of free hemoglobin in the liquid part of the blood (the serum).

    Haptoglobin is a protein produced by the liver. The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.


  7. Subject's Average International Normalized Ratio(INR)/Partial Thromboplastin Time(PTT) [ Time Frame: Baseline, 6 months, and annually for up to 5 years ]

    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 liquid portion (plasma) of the blood to clot.

    PTT is a blood test that looks at how long it takes for the blood to clot.


  8. Urine urobilinogen (if necessary for subjects 12 years and under) [ Time Frame: Baseline, 6 months, and annually for up to 5 years ]
    Laboratory Analysis of urobilinogen in urine measures the amount of urobilinogen in a urine sample. Urobilinogen is formed from the reduction of bilirubin. Bilirubin is a yellowish substance found in your liver that helps break down red blood cells.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve
  2. Is greater than or equal to 5 years of age
  3. Subject and/or subject's legal representative has provided written informed consent as approved and required by the respective institutional review board and agrees to its provisions. NOTE: Written consent must be obtained prior to any research related test being performed.

Exclusion criteria:

A subject meeting any of the following criteria shall be excluded:

  1. Valve-in-conduit procedure
  2. Requires emergency surgery
  3. Has acute myocardial infarction (MI) within 30 days prior to screening date
  4. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to screening date
  5. Has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to screening date
  6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to screening date
  7. Has renal insufficiency as determined by creatinine (S-Cr) level ~ 2.5 mg/dL within 60 days prior to screening visit or end-stage renal disease
  8. Has documented leukopenia (WBC < 3.5x 103/I-lL), acute anemia (Hgb <10.0 g/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50xl03/I-lL) accompanied by history of bleeding diathesis or coagulopathy within 60 days prior to screening date
  9. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
  10. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
  11. RVOT aneurysm unless treated during pulmonary valve replacement surgery
  12. Has prior organ transplant or is currently an organ transplant candidate
  13. Was previously implanted with INSPIRIS RESILIA Pulmonary valve
  14. Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve, mechanical valve, or annuloplasty ring
  15. Need for concomitant replacement of the aortic, mitral or tricuspid valves
  16. Has presence of non-cardiac disease limiting life expectancy to less than 12 months
  17. Is Currently or has recently participated (within 6 weeks) in another investigational drug or device trial
  18. Positive urine or serum pregnancy test in female subjects of child-bearing potential and/or nursing mothers, or planning to become pregnant within 1 year of study valve implant
  19. Has left ventricular ejection fraction ≤20% as validated by diagnostic procedure prior to screening date
  20. Currently incarcerated or unable to give voluntary informed consent
  21. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to screening date
  22. Patients with hypersensitivity to metal alloys that contain cobalt, chromium, nickel, molybdenum, manganese, carbon, beryllium and iron
  23. Patients with hypersensitivity to latex

    Intra-Op Exclusion Criterion:

  24. Significant injury to the heart upon entry defined as emergent cardiopulmonary bypass requiring femoral cannulation

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): NCT02656290


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Christopher Baird, MD Boston Children’s Hospital

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02656290     History of Changes
Other Study ID Numbers: 2015-03
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases