EDWARDS INTUITY Valve System CADENCE-MIS Study

A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve Replacement Using Minimally InvaSive Techniques

The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.

This is a randomized study to compare the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system in a minimally invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach, in patients with logistic EuroScore < 20 undergoing elective isolated aortic valve replacement (AVR) surgery.

Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and to explore additional healthcare resource utilization endpoints.

Inclusion:

1. adult male or female ≥18 years of age
2. symptomatic for aortic stenosis / mixed aortic stenosis and aortic insufficiency disease for which isolated surgical aortic valve replacement without concomitant procedures is planned
3. EuroSCORE <20
4. NYHA Class ≥II
5. Subject has signed and dated the investigation informed consent form prior to study specific procedures are performed
6. Subject is geographically stable and agrees to participate in follow-up assessments as specified in the protocol and informed consent

Exclusion (i.a.):

1. pure aortic insufficiency

2. previous cardiac surgery (involved FS or MIS approach)

3. congenital true bicuspid / unicuspid aortic valve

4. requires emergency surgery or has had emergency surgery for any reason

   ≤ 1 month before the intended treatment

5. LVEF <25%

6. active endocarditis ≤ 6 months before the intended treatment

7. acute MI ≤ 90 days before the intended treatment

8. had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery

9. oxygen or ventilator dependent

10. life expectancy < 12 months

11. substance abuser

12. Female subject is pregnant or lactating

13. documented leukopenia (WBC < 3.5x 103/μL), acute anemia (Hgb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy

14. hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure

15. documented echocardiographic evidence of intracardiac mass, thrombus or vegetation

16. renal insufficiency as determined by Serum creatinine ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis

17. documented hyperparathyroidism

18. currently participating in an investigational drug or device trial for which follow-up has not yet been completed

19. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition

Intra-operative Exclusion:

1. has calcium on the anterior mitral leaflet which cannot be removed
2. has extensive calcification of the aortic root
3. Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus
4. has left atrial thrombus
5. The position of the coronary ostia relative to the EDWARDS INTUITY Valve would result in obstruction of blood flow
6. hemodynamically unstable during the procedure requiring the procedure to be aborted prior to insertion of the study bioprosthesis and delivery system
7. Study device is not available in the correct size for the subject