Back to resultsCOMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement (COMMENCE-P)
Primary Purpose
Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Edwards Pericardial Aortic Bioprosthesis Model 11000A
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Valve Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Has pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve
- Is greater than or equal to 5 years of age
- 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:
- Valve-in-conduit procedure
- Requires emergency surgery
- Has acute myocardial infarction (MI) within 30 days prior to screening date
- Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to screening date
- Has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to screening date
- Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to screening date
- 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
- 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
- Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
- Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
- RVOT aneurysm unless treated during pulmonary valve replacement surgery
- Has prior organ transplant or is currently an organ transplant candidate
- Was previously implanted with INSPIRIS RESILIA Pulmonary valve
- Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve, mechanical valve, or annuloplasty ring
- Need for concomitant replacement of the aortic, mitral or tricuspid valves
- Has presence of non-cardiac disease limiting life expectancy to less than 12 months
- Is Currently or has recently participated (within 6 weeks) in another investigational drug or device trial
- 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
- Has left ventricular ejection fraction ≤20% as validated by diagnostic procedure prior to screening date
- Currently incarcerated or unable to give voluntary informed consent
- Documented history of substance (drug or alcohol) abuse within the last 5 years prior to screening date
- Patients with hypersensitivity to metal alloys that contain cobalt, chromium, nickel, molybdenum, manganese, carbon, beryllium and iron
Patients with hypersensitivity to latex
Intra-Op Exclusion Criterion:
- Significant injury to the heart upon entry defined as emergent cardiopulmonary bypass requiring femoral cannulation
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Edwards Pericardial Aortic Bioprosthesis Model 11000A
Arm Description
Pulmonary valve replacement
Outcomes
Primary Outcome Measures
Percent of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1 Year Post-implant.
Subject's freedom from device or procedure related death and/or reoperation at 1 year post-implant. Time to events were estimated by Kaplan-Meier method.
Secondary Outcome Measures
Percent of Early Adverse Events
Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Late Adverse Events
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
Subject's Average Mean Gradient
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.
Subject's Average Peak Gradients
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.
Subject's Amount of Valvular Regurgitation
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.
TR Gradient
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.
Peak Velocity
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.
Doppler Velocity Index (DVI)
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.
Transvalvular VTI
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.
Subject's New York Heart Association (NYHA) Functional Class for Subjects Older Than 12 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.
Cross-tabulation of New York Heart Association (NYHA) Functional Class for Subjects Older Than 12 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.
Modified Ross Heart Failure Classification for Subjects 12 Years and Under
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
Cross-tabulation of Modified Ross Heart Failure Classification for Subjects 12 Years and Under
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
Full Information
NCT ID
NCT02656290
First Posted
January 12, 2016
Last Updated
February 16, 2023
Sponsor
Edwards Lifesciences
1. Study Identification
Unique Protocol Identification Number
NCT02656290
Brief Title
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
Acronym
COMMENCE-P
Official Title
Prospective, Non-Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
November 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Edwards Pericardial Aortic Bioprosthesis Model 11000A
Arm Type
Experimental
Arm Description
Pulmonary valve replacement
Intervention Type
Device
Intervention Name(s)
Edwards Pericardial Aortic Bioprosthesis Model 11000A
Intervention Description
Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium
Primary Outcome Measure Information:
Title
Percent of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1 Year Post-implant.
Description
Subject's freedom from device or procedure related death and/or reoperation at 1 year post-implant. Time to events were estimated by Kaplan-Meier method.
Time Frame
1 year post-implant
Secondary Outcome Measure Information:
Title
Percent of Early Adverse Events
Description
Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Time Frame
Events occurring within 30 days of procedure
Title
Late Adverse Events
Description
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
Time Frame
6 months, and annually for up to 5 years
Title
Subject's Average Mean Gradient
Description
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.
Time Frame
Baseline, 6 months, and annually thereafter for up to 5 years
Title
Subject's Average Peak Gradients
Description
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.
Time Frame
Baseline, 6 months, and annually thereafter for up to 5 years
Title
Subject's Amount of Valvular Regurgitation
Description
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.
Time Frame
Baseline, 6 months, and annually thereafter for up to 5 years
Title
TR Gradient
Description
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.
Time Frame
Baseline, 6 months, and annually thereafter for up to 5 years
Title
Peak Velocity
Description
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.
Time Frame
Baseline, 6 months, and annually thereafter for up to 5 years
Title
Doppler Velocity Index (DVI)
Description
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.
Time Frame
Baseline, 6 months, and annually thereafter for up to 5 years
Title
Transvalvular VTI
Description
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.
Time Frame
Baseline, 6 months, and annually thereafter for up to 5 years
Title
Subject's New York Heart Association (NYHA) Functional Class for Subjects Older Than 12 Years
Description
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.
Time Frame
Baseline, 30 days, 6 months, and annually thereafter for up to 5 years
Title
Cross-tabulation of New York Heart Association (NYHA) Functional Class for Subjects Older Than 12 Years
Description
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.
Time Frame
Baseline and 1 Year
Title
Modified Ross Heart Failure Classification for Subjects 12 Years and Under
Description
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
Time Frame
Baseline, 30 days, 6 months, and annually for up to 5 years
Title
Cross-tabulation of Modified Ross Heart Failure Classification for Subjects 12 Years and Under
Description
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
Time Frame
Baseline and 1 Year
Other Pre-specified Outcome Measures:
Title
Subject's Average White Blood Cell Count
Description
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Time Frame
Baseline, 6 months, and annually for up to 5 years
Title
Subject's Average Red Blood Cells Count
Description
Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
Time Frame
Baseline, 6 months, and annually for up to 5 years
Title
Subject's Average Hemoglobin Count
Description
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Time Frame
Baseline, 30 days, 6 months, and annually for up to 5 years
Title
Subject's Average Hematocrit Percentage
Description
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.
Time Frame
Baseline, 6 months, and annually for up to 5 years
Title
Subject's Average Platelet Count
Description
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Time Frame
Baseline, 6 months, and annually for up to 5 years
Title
Subject's Average Plasma Free Hemoglobin or Haptoglobin or Serum LDH
Description
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.
Time Frame
Baseline, 6 months, and annually for up to 5 years
Title
Subject's Average International Normalized Ratio(INR)/Partial Thromboplastin Time(PTT)
Description
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.
Time Frame
Baseline, 6 months, and annually for up to 5 years
Title
Urine Urobilinogen (if Necessary for Subjects 12 Years and Under)
Description
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.
Time Frame
Baseline, 6 months, and annually for up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve
Is greater than or equal to 5 years of age
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:
Valve-in-conduit procedure
Requires emergency surgery
Has acute myocardial infarction (MI) within 30 days prior to screening date
Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to screening date
Has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to screening date
Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to screening date
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
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
Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
RVOT aneurysm unless treated during pulmonary valve replacement surgery
Has prior organ transplant or is currently an organ transplant candidate
Was previously implanted with INSPIRIS RESILIA Pulmonary valve
Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve, mechanical valve, or annuloplasty ring
Need for concomitant replacement of the aortic, mitral or tricuspid valves
Has presence of non-cardiac disease limiting life expectancy to less than 12 months
Is Currently or has recently participated (within 6 weeks) in another investigational drug or device trial
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
Has left ventricular ejection fraction ≤20% as validated by diagnostic procedure prior to screening date
Currently incarcerated or unable to give voluntary informed consent
Documented history of substance (drug or alcohol) abuse within the last 5 years prior to screening date
Patients with hypersensitivity to metal alloys that contain cobalt, chromium, nickel, molybdenum, manganese, carbon, beryllium and iron
Patients with hypersensitivity to latex
Intra-Op Exclusion Criterion:
Significant injury to the heart upon entry defined as emergent cardiopulmonary bypass requiring femoral cannulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Baird, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available to other researchers
Learn more about this trial
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
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