EDWARDS INTUITY Valve System CADENCE-MIS Study

Edwards Lifesciences100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Aortic Valve Disease Aortic Stenosis

Interventions

EDWARDS INTUITY Valve System, Model 8300ADEVICE

To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing MIS-AVR.

Stented Aortic BioprosthesesDEVICE

In comparison to control valves available on the market undergoing FS-AVR

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Leipzig Heart Center

Leipzig, Saxony, Germany

Outcomes

Primary Outcomes

Median Subject Time Spent on Cardiopulmonary Cross Clamp

Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.

Time frame: At time of surgery; an average of 1 hour

Median Amount of Time Subject Spent on Cardiopulmonary Bypass

Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.

Time frame: At time of surgery; an average of 1 hour

Secondary Outcomes

Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.

The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.

Time frame: Baseline and 2 Years.

Subject's Average Mean Gradients (mmHg) Measurements Over Time.

Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year

Data from ClinicalTrials.gov

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Subject's Average Peak Gradients (mmHg) Measurements Over Time.

Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.

Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year

Subject's Effective Orifice Area (EOA) Measurement Over Time.

Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.

Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year

Amount of Paravalvular Leak Over Time.

Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

Time frame: Discharge, 30 days, 3 month, 1 year

Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.

Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.

Time frame: Prior to Surgery

Subjects Who Required a Thoracic Resternotomy Over Time

Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.