Clinical evaluation of the Edwards Aortic & Mitral Valves: Models 11000A and 11000M (COMMENCE TRIAL)

Principal Investigator: DavidBull
Keywords: mitral valve , aortic valve , cardiac surgery , valve replacement Department: Cardiothoracic Divison
IRB Number: 00072440 Co Investigator:
Specialty: Cardiothoracic Surgery
Sub Specialties:

Contact Information

CarlynSander
Carlyn.Sander@hsc.utah.edu
8015852582

Brief Summary

The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization, and packaging of the FDA-approved (P860057/S042) Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX, which will be designated as the Edwards Pericardial Aortic Bioprosthesis Model 11000A, and the Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis, Model 7300TFX, which will be designated as the Edwards Pericardial Mitral Bioprosthesis Model 11000M do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve. The only differences between the Model 3300TFX and the Model 11000A and between the Model 7300TFX and the Model 11000M are modifications in tissue processing, valve sterilization, and packaging.

Inclusion Criteria

Each subject is required to meet all of the following 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

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 multiple valve replacement/repair, unless the patient is having a mitral and tricuspid valve replacement--these 2 valves only are allowed in the same surgery

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. Requires graft replacement of the ascending aorta

7. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic or mitral valve replacement surgery

8. 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

9. 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

10. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery

11. Has presence of non-cardiac disease limiting life expectancy to less than 12 months

12. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)

13. Diagnosed with abnormal calcium metabolism and hyperparathyroidism

14. Exhibits left ventricular ejection fraction 20% as validated by diagnostic procedure prior to planned valve surgery

15. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation

16. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery

17. Documented leukopenia (WBC < 3.5x 103/μL), acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), thrombocytopenia (platelet count < 50x103/μL) accompanied by history of bleeding diathesis or coagulopathy

18. Has prior organ transplant or is currently an organ transplant candidate

19. Current or recent participation (within 6 weeks prior to surgery) in another investigational drug or device trial

20. Was previously implanted with trial device (Model 11000A or Model 11000M)

21. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial

22. Currently incarcerated or unable to give voluntary informed consent

23. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant

24.  Requires concomitant left ventricular assist device (LVAD) placement