EDWARDS INTUITY Valve System CADENCE-MIS Study

Edwards Lifesciences

Status

Completed

Conditions

Aortic Valve Disease

Aortic Stenosis

Treatments

Device: Stented Aortic Bioprostheses

Device: EDWARDS INTUITY Valve System, Model 8300A

Study type

Interventional

Funder types

Industry

Identifiers

NCT02672553

2011-12 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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

Exclusion (i.a.):

pure aortic insufficiency
previous cardiac surgery (involved FS or MIS approach)
congenital true bicuspid / unicuspid aortic valve
requires emergency surgery or has had emergency surgery for any reason

≤ 1 month before the intended treatment
LVEF <25%
active endocarditis ≤ 6 months before the intended treatment
acute MI ≤ 90 days before the intended treatment
had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery
oxygen or ventilator dependent
life expectancy < 12 months
substance abuser
Female subject is pregnant or lactating
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
hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
documented echocardiographic evidence of intracardiac mass, thrombus or vegetation
renal insufficiency as determined by Serum creatinine ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis
documented hyperparathyroidism
currently participating in an investigational drug or device trial for which follow-up has not yet been completed
Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition

Intra-operative Exclusion:

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