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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, 2018
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 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: Model 11000A in pulmonary position 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 to assess the safety and effectiveness of the Edwards Peri-cardial Aortic Bioprosthesis Model 11000A in the pulmonary position. The trial will include male and female subjects five year and older requiring pulmonary valve replacement of their native or prosthetic valve. 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
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: AModel 11000A for PVR
Pulmonary valve replacement
Device: Model 11000A in pulmonary position
Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position




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

Secondary Outcome Measures :
  1. Clinically acceptable hemodynamic performance confirmed by core lab evaluation of echocardiography [ Time Frame: 1 year ]


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

Exclusion criteria:

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

  1. Requires 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 study trial device
  14. Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve, mechanical valve
  15. Need for concomitant replacement of the aortic, mitral or tricuspid valves or annuloplasty ring that will remain in situ
  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
  19. Has left ventricular ejection fraction ≤20% as validated by diagnostic procedure prior to screening date or planning to become pregnant during the participation in the trial
  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

    Intra-Op Exclusion Criterion:

  22. Significant injury to the heart upon entry

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, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Pulmonary Valve Insufficiency
Respiratory Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases