Brief Title
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
Official Title
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)
Brief Summary
The objective of this trial is to confirm that the modifications to tissue processing, valve
sterilization and packaging do not raise any new questions of safety and effectiveness in
subjects who require replacement of their native or prosthetic aortic or mitral valve.
Detailed Description
Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve
replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement
(MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include
male and female patients, 18 years or older, requiring replacement for a diseased, damaged,
or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and
assessed after implant for up to 5 years.
Study Type
Interventional
Primary Outcome
Subjects With Structural Valve Deterioration
Secondary Outcome
Percentage of Subjects With Early Adverse Events
Condition
Aortic Stenosis
Intervention
Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
Study Arms / Comparison Groups
Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M
Description: Aortic/Mitral valve replacement therapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
777
Start Date
December 2012
Completion Date
August 2026
Primary Completion Date
August 2017
Eligibility Criteria
Eligibility Criteria:
Inclusion Criteria:
1. Is 18 years or older
2. Provides written informed consent prior to trial procedures
3. Agrees to attend all follow-up assessments for up to 5 years and is willing to comply
with specified follow-up evaluations at clinical investigational sites that are
participating in the COMMENCE trial and/or obtain the protocol-specified diagnostic
tests at centers that are under the same IRB or the same healthcare system
4. Diagnosed with aortic or mitral valve disease requiring valve replacement based on
pre- operative evaluation
5. Scheduled to undergo planned aortic or mitral valve replacement with or without
concomitant bypass surgery
6. Scheduled to undergo planned aortic valve replacement with or without resection and
replacement of the ascending aorta from the sinotubular junction and without the need
for circulatory arrest for hemi arch or arch replacement
Exclusion criteria:
A subject meeting any of the following criteria shall be excluded:
1. Requires emergency surgery
2. Requires planned multiple valve replacement/ repair (with the exception of mitral
valve replacement with tricuspid valve repair)
3. Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical
valve, or annuloplasty ring that will remain in situ
4. Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
5. Requires surgical replacement of the aortic root
6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the
scheduled aortic or mitral valve replacement surgery
7. Has renal insufficiency as determined by creatinine (S-Cr) level ≥ 2.5 mg/dL or end
-stage renal disease requiring chronic dialysis at screening visit
8. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient
ischemic attack (TIA) within 6 months (180 days) prior to planned valve surgery
9. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery
10. Has presence of non-cardiac disease limiting life expectancy to less than 12 months
11. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
12. Diagnosed with abnormal calcium metabolism and hyperparathyroidism
13. Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure
prior to planned valve surgery
14. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
15. Hemodynamic or respiratory instability requiring inotropic support, mechanical
circulatory support, or mechanical ventilation within 30 days prior to planned valve
surgery
16. Documented leukopenia (WBC < 3.5x 10³/μL), acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L)
or thrombocytopenia (platelet count < 50x 10³/μL) accompanied by history of bleeding
diathesis and coagulopathy
17. Has prior organ transplant or is currently an organ transplant candidate
18. Current or recent participation (within 6 weeks prior to surgery) in another drug or
device trial
19. Was previously implanted with trial device (Model 11000A or Model 11000M)
20. Pregnant (female subject of childbearing potential only), lactating or planning to
become pregnant during the duration of participation in trial
21. Currently incarcerated or unable to give voluntary informed consent
22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior
to implant
23. Requires concomitant left ventricular assist device (LVAD) placement
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
John Puskas, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01757665
Organization ID
2012-02
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
John Puskas, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai
Verification Date
January 2020