EDWARDS INTUITY Valve System CADENCE-MIS Study
EDWARDS INTUITY Valve System CADENCE-MIS Study
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