Clinical trial NCT02656290: COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Valve Insufficiency
Pulmonary Valve Degeneration
Congenital Pulmonary Valve Abnormality
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-01-14
Enrollment: 26
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant.
timeFrame: 1-year post-implant
Secondary outcomes:
measure: Percentage of Early Adverse Events
timeFrame: Percentage of events occurring within 30 days of procedure
measure: Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort.
timeFrame: Events occurring ≥ 31 days and up through 5 years post implant.
measure: Subject's Average Mean Gradient Measurements Over Time.
timeFrame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
measure: Subject's Average Peak Gradient Measurements Over Time.
timeFrame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
measure: Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size
timeFrame: Discharge, 30 days, 3 months, and annually thereafter for up to 5 years
measure: Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size
timeFrame: Discharge, 30 days, 3 months, and annually thereafter for up to 5 years
measure: Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time.
timeFrame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
measure: Subject's Average Peak Velocity Measurement Over Time
timeFrame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
measure: Subject's Average Doppler Velocity Index (DVI)
timeFrame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
measure: Subject's Average Transvalvular Velocity Time Interval (VTI)
timeFrame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
measure: Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class
timeFrame: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years
Other outcomes:
measure: Subject's Average White Blood Cell Count
timeFrame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
measure: Subject's Average Red Blood Cell Count
timeFrame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
measure: Subject's Average Hemoglobin Count
timeFrame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
measure: Subject's Average Hematocrit Percentage
timeFrame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
measure: Subject's Average Platelet Count
timeFrame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
measure: Subject's Average Serum LDH
timeFrame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
measure: Subject's Average Plasma Free Hemoglobin
timeFrame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
measure: Subject's Average International Normalized Ratio (INR)
timeFrame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
measure: Subject's Average Urine Urobilinogen (if Necessary for Subjects 12 Years and Under)
timeFrame: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Christopher Baird, MD
role: PRINCIPAL_INVESTIGATOR
References: