Pulmonary Valve InsufficiencyCOMMENCE-PNCT02656290
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
A study testing Edwards Pericardial Aortic Bioprosthesis Model 11000A in people with Pulmonary Valve Insufficiency and Pulmonary Valve Degeneration, run by Edwards Lifesciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality
- What is being tested?
- Edwards Pericardial Aortic Bioprosthesis Model 11000A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 28 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Prospective, Non-Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
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.
Read the 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.
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality
- Being tested
- Edwards Pericardial Aortic Bioprosthesis Model 11000A
- Medical subject headings
- Pulmonary Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards Pericardial Aortic Bioprosthesis Model 11000ADevice
Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium
| Study group | Role | What they receive |
|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Experimental | Pulmonary valve replacement Receives: Device: Edwards Pericardial Aortic Bioprosthesis Model 11000A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage 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. A higher number means a better outcome.
Measured: 1-year post-implant
Secondary outcomes (11)
Percentage 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.
Measured: Percentage of events occurring within 30 days of procedure
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort.
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visit (or contact) or adverse event. Late patient year calculation: [(Number of late events/sum of late patient years) x 100]
Measured: Events occurring ≥ 31 days and up through 5 years post implant.
Subject's Average Mean Gradient Measurements Over Time.
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Measured: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Subject's Average Peak Gradient Measurements Over Time.
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. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Measured: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size
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 0 to 4, where 0 represents no regurgitation/leak (a better outcome) and 4 represents severe regurgitation/leak (a worse outcome).
Measured: Discharge, 30 days, 3 months, and annually thereafter for up to 5 years
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size
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 (a better outcome) and 4 represents severe regurgitation (a worse outcome).
Measured: Discharge, 30 days, 3 months, and annually thereafter for up to 5 years
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time.
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. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Measured: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Subject's Average Peak Velocity Measurement Over Time
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. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Measured: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Subject's Average Doppler Velocity Index (DVI)
The Doppler Velocity Index (DVI) is a calculation of the ratio of the sub valvular velocity obtained by pulse wave Doppler and the maximum velocity obtained by continuous wave Doppler across the prosthetic valve, i.e. Time velocity interval (TVI) of the pulmonic valve / TVI of the RVOT. There are no normal ranges issued by the American Society of Echocardiography's Guidelines and Standards Committee for the pulmonary valve, however the expectation is that DVI should remain relatively steady over time but will generally decrease as the degree of stenosis (narrowing or constriction of the valve opening) worsens.
Measured: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Subject's Average Transvalvular Velocity Time Interval (VTI)
Transvalvular regurgitation velocity time interval (VTI) is defined as the measurement in centimeters of the blood flowing backwards through the tricuspid valve, averaged over time. There are no defined normal ranges for VTI. The VTI value is dependent on the function of the right ventricle of the heart (chamber within the heart that is responsible for pumping oxygen-depleted blood to the lungs) and the expectation is the value should be relatively steady over time.
Measured: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class
The New York Heart Association (NYHA)/Modified Ross 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, shortness of breath.
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath.
Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or shortness of breath.
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.
Changes in NYHA/Modified Ross HF classification from the preoperative baseline to the respective completed follow-up visits are shown as the number of subjects in each class who improved, worsened, or stayed the same.
Measured: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2018
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Baird, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656290
- Sponsor's protocol ID
- 2015-03
- Acronym
- COMMENCE-P
- Status last verified
- Nov 2023
- First submitted
- 12 Jan 2016
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
- ClinicalTrials.gov ID
- NCT02656290
- Acronym / sponsor ID
- COMMENCE-P / 2015-03
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Posted 17 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000A | Experimental | Device: Edwards Pericardial Aortic Bioprosthesis Model 11000APulmonary valve replacement |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edwards Pericardial Aortic Bioprosthesis Model 11000AEdwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium | Device | Edwards Pericardial Aortic Bioprosthesis Model 11000A |
Primary outcome
Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant.
Time frame: 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. A higher number means a better outcome.
11 secondary outcomes
Percentage of Early Adverse Events
Time frame: Percentage of events occurring within 30 days of procedure
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort.
Time frame: Events occurring ≥ 31 days and up through 5 years post implant.
Subject's Average Mean Gradient Measurements Over Time.
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Subject's Average Peak Gradient Measurements Over Time.
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size
Time frame: Discharge, 30 days, 3 months, and annually thereafter for up to 5 years
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size
Time frame: Discharge, 30 days, 3 months, and annually thereafter for up to 5 years
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time.
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Subject's Average Peak Velocity Measurement Over Time
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Subject's Average Doppler Velocity Index (DVI)
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Subject's Average Transvalvular Velocity Time Interval (VTI)
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class
Time frame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Baird, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards Pericardial Aortic Bioprosthesis Model 11000A in people with Pulmonary Valve Insufficiency and Pulmonary Valve Degeneration, run by Edwards Lifesciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant. (time frame: 1-year post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.