Overview

This trial is active, not recruiting.

Conditions aortic stenosis, mitral stenosis, aortic valve insufficiency, mitral valve insufficiency, heart failure
Treatment edwards aortic and mitral bioprostheses models 11000a and 11000m
Sponsor Edwards Lifesciences
Start date December 2012
End date December 2016
Trial size 777 participants
Trial identifier NCT01757665, 2012-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Aortic/Mitral valve replacement therapy
edwards aortic and mitral bioprostheses models 11000a and 11000m
Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M

Primary Outcomes

Measure
Safety Endpoints
time frame: When 800 patient years for the aortic valve position and 800 aortic patient years and 100 mitral patient years of cumulative follow up for the mitral valve position have been achieved.

Secondary Outcomes

Measure
Effectiveness Endpoints
time frame: Up to 5-Years at each scheduled follow-up visit

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Principal investigator John Puskas, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.