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

Edwards Lifesciences26 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Valve Insufficiency Pulmonary Valve Degeneration Congenital Pulmonary Valve Abnormality

Interventions

Edwards Pericardial Aortic Bioprosthesis Model 11000ADEVICE

Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 1-year post-implant

Secondary Outcomes

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.

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.

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: \[(Number of late events/sum of late patient years) x 100\]

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.