Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

Edwards Lifesciences934 enrolled

Overview

The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of five years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

934

Conditions

Aortic Valve Stenosis Aortic Valve Stenosis With Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence

Interventions

EDWARDS INTUITY valveDEVICE

Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Inclusion Criteria - Subjects will be required to meet all inclusion criteria: 1. Male or female, age 18 years or older 2. Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replacement as indicated in the preoperative evaluation 3. Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery 4. Provide written informed consent 5. Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up Exclusion Criteria: \- Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present: 1. Pure aortic insufficiency 2. Requires emergency surgery 3. Previous aortic valve replacement 4. Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ 5. Requires multiple valve replacement/repair 6. Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal) 7. Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention 8. Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery 9. Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery 10. Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis 11. Hyperparathyroidism 12. MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure 13. Presence of non-cardiac disease limiting life expectancy to less than 12 months 14. Hypertrophic obstructive cardiomyopathy (HOCM) 15. Left ventricular ejection fraction ≤ 25% 16. Documented history of substance (drug or alcohol) abuse within the last 5 years 17. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation 18. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure 19. Pregnancy, lactation, or planning to become pregnant; 20. Currently incarcerated or unable to give voluntary informed consent 21. Leucopenia (WBC \< 3.5x 103/µL), or acute anemia (Hgb \< 10.0 gm/dL or 6 mmol/L), or thrombocytopenia (platelet count \< 50x 103/µL), or history of bleeding diathesis or coagulopathy 22. History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome) 23. Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial * Intra-operative Exclusion Criteria 24. Anatomic variances which contraindicate implant of the trial valve, such as: 1. anomalous coronary arteries 2. annular deformation or extensive calcification of the annulus or aortic root which cannot be removed 3. significant calcium on the anterior mitral leaflet 4. pronounced septal calcification 5. position of coronary ostia relative to Model 8300ACD valve that would result in obstruction of blood flow 25. Available devices are not suitably sized for the subject's annulus

Locations (29)

Outcomes

Primary Outcomes

Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort

Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]

Time frame: Events occurring ≥ 31 days and up through 8 years post-implant

Secondary Outcomes

Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success

Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.

Time frame: Day of procedure

Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success

Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.

Time frame: Day of procedure through discharge or 10 days post index procedure, whichever comes first.

Average Amount of Time Subject Spent on Cardiopulmonary Bypass

Surgical and hospitalization factors - Cardiopulmonary bypass time

Time frame: Day of procedure

Average Subject Time on Cardiopulmonary Cross Clamp

Surgical and hospitalization factors - Cardiopulmonary cross clamp time

Time frame: Day of procedure

Average Number of Days Subjects Were in the Intensive Care Unit (ICU)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Keck Hospital of University of Southern California

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Stanford University

Palo Alto, California, United States

Mercy General Hospital

Sacramento, California, United States

Florida Hospital

Orlando, Florida, United States

Northwestern University

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

The University of Michigan Medical School

Ann Arbor, Michigan, United States

Washington University - Barnes Jewish Hospital

St Louis, Missouri, United States

...and 19 more locations

Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.

Time frame: Day of procedure through discharge from the hospital

Subject's New York Heart Association (NYHA) Classification Over Time

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, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years

Subject's Average Mean Gradient 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. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.

Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up

Subject's Average Peak Gradient 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. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.

Time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up

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. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.