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EDWARDS INTUITY Valve System FOUNDATION Study (FOUNDATION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02338154
Recruitment Status : Completed
First Posted : January 14, 2015
Results First Posted : October 14, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:

The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.

The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.


Condition or disease
Aortic Valve Disease Aortic Stenosis Rapid Deployment Valves

Detailed Description:

Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis. Over the past several years, life expectancy has increased in industrial nations, but this has been accompanied by a rising rate of elderly patients with multiple illnesses.

Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2—5 years from the onset of symptoms. More recent studies have confirmed the dismal prognosis of severe aortic stenosis. Advanced age, reduced left ventricular ejection fraction, congestive heart failure and renal insufficiency appear to be independent predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also share a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac mortality and improving symptoms.

Bioprostheses offer several advantages over mechanical bioprostheses, the most important being freedom from anticoagulation with a low rate of thromboembolic accidents.

In response to clinical need and in support of advances in minimally invasive surgical approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Valve System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times, while facilitating a less invasive approach to aortic valve replacement.

The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY Delivery System, Model 8300D; the valve is based on prior heart valve designs which have a long history of safety and effectiveness and have incorporated additional features designed to improve patient outcomes and safety.

With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Valve system is well suited for smaller incisions and tight access, with an emphasis on procedural efficiency within existing operating suite of the surgeon.

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Study Type : Observational
Actual Enrollment : 516 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study.
Study Start Date : July 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Subject's Average Time Spent on Cardiopulmonary Cross Clamp [ Time Frame: At time of surgery; an average of 1 hour ]
    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.


Other Outcome Measures:
  1. Subject's Average Time Spent on Cardiopulmonary Bypass [ Time Frame: At time of surgery; an average of 1.5 hours ]
    Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.

  2. Subject's Average Skin-to-skin Time [ Time Frame: At time of surgery; an average of 3.5 hours ]
    The time from start of skin incision to end of skin closure.

  3. Subject's Device Technical Success [ Time Frame: At time of surgery ]
    Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with the subject leaving the operating room (OR) with valve in place.

  4. Subject's Average Health Care Utilization [ Time Frame: Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively. ]
    The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.

  5. Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline [ Time Frame: 30 days, 3 months, 1 year, 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.


  6. Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time [ Time Frame: Baseline, 3 months ]
    The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.

  7. Subject's Average Mean Gradient Measurements [ Time Frame: Baseline, discharge, 3 months, and 1 year ]
    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.

  8. Subject's Average Peak Gradients (mmHg) Measurements Over Time [ Time Frame: Baseline, discharge, 3 months, and 1 year ]
    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.

  9. Subject's Average Effective Orifice Area Measurements [ Time Frame: Baseline, discharge, 3 months, 1 year ]
    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.

  10. Subject's Average Effective Orifice Area Index (EOAI) Measurements [ Time Frame: Baseline, Discharge, 3 months, 1 year ]
    Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.

  11. Subject's Average Performance Index Measurements [ Time Frame: Discharge, 3 Months, 1 Year ]
    Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.

  12. Subject's Average Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Baseline, discharge, 3 months, 1 year ]
    Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. Ejection fraction is evaluated by echocardiography over time. A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%.

  13. Subject's Amount of Aortic Valvular Regurgitation Over Time. [ Time Frame: Discharge, 3 months, 1 year ]
    Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

  14. Subject's Amount of Paravalvular Leak Over Time. [ Time Frame: Discharge, 3 months, 1 year ]
    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.

  15. Subject's Average Cardiac Output Over Time [ Time Frame: Discharge, 3 months, 1 year ]
    The amount of blood the heart pumps through the circulatory system in a minute.

  16. Subject's Average Cardiac Output Index [ Time Frame: Discharge, 3 Months, 1 Year ]
    A hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA).

  17. Subject's Average Left Ventricular End-Diastolic Dimension [ Time Frame: Baseline, Discharge, 3 Months, 1 Year ]
    The measurement of the heart's left ventricle at end diastole.

  18. Subject's Average Left Ventricular End-Systolic Dimension [ Time Frame: Baseline, Discharge, 3 Months, 1 Year ]
    The measurement of the heart's left ventricle at end systole.

  19. Left Ventricular End-diastolic Volume (LVEDV) [ Time Frame: Baseline, Discharge, 3 Months, 1 Year ]
    Left Ventricular end-diastolic volume (LVEDV) is the amount of (volume) of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole.

  20. Left Ventricular End-systolic Volume (LVESV) [ Time Frame: Baseline, Discharge, 3 Months, 1 Year ]
    Left Ventricular end-systolic volume (LVESV) is the amount of (volume) of blood in the left ventricle at the end of the heart's contraction, or systole, and the beginning of filling, or diastole.

  21. Percentage of Subjects With Early Adverse Events [ Time Frame: Events occurring within 30 days of procedure ]
    Number of Subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.

  22. Percentage of Late Adverse Events Divided by Late Patient Years [ Time Frame: Events occurring >= 31 days and up through 2 years post-implant ]
    Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects, age 18 or older, that have been diagnosed with aortic stenosis or stenosis-based insufficiency and are scheduled to undergo surgical aortic valve replacement are eligible for participation in this study. Study subjects shall be drawn from the general patient populations served by each investigational center. Candidates for this study must meet all of the following inclusion criteria and none of the exclusion criteria.
Criteria

Inclusion Criteria:

  1. Subject is 18 years or older
  2. Subject presents with aortic stenosis or stenosis-based insufficiency of an aortic valve requiring a planned replacement of the native aortic valve or previously implanted aortic prosthesis.
  3. Subject has signed and dated the investigation informed consent forms prior to study-specific procedures are performed.
  4. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.

Exclusion Criteria:

  1. History of active endocarditis within three months of scheduled surgery
  2. Subject is diagnosed with pure aortic insufficiency
  3. Aneurysm of the aortic root and/or ascending aorta

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338154


Locations
Show Show 27 study locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Dr. Glauber, MD Organizational Affiliation: OSPEDALE "G. PASQUINUCCI" CREAS IFC-CNR
Principal Investigator: Prof.Christopher Young, MD FRCS Guy's & St Thomas' Hospital

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02338154    
Other Study ID Numbers: 2011-13
First Posted: January 14, 2015    Key Record Dates
Results First Posted: October 14, 2019
Last Update Posted: November 22, 2019
Last Verified: November 2019
Keywords provided by Edwards Lifesciences:
Aortic Valve Replacement
Aortic Stenosis
EDWARDS INTUITY
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction