EDWARDS INTUITY Valve System FOUNDATION Study (FOUNDATION)

Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study.

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis; Aortic Valve Disease; 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.

• Study Type: Observational
• Enrollment (Actual): 516

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Salzburger Universitatsklinikum
  • St Pölten, Austria, 3100
    • Landesklinikum - St. Pölten
  • Vienna, Austria, 1090
    • Klinisshe Abteiluing Für Herz-thoraxchirurgie
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital Skejby
• France
  • Dijon, France, 21074
    • CHU Bocage Central Dijon
  • Marseille Cedex, France, 13285
    • Hopital Saint Joseph - Marseille
  • Mulhouse Cedex, France, 68051
    • Centre Hospitalier de Mulhouse
  • St Denis, France, 93200
    • Centre Cardiologique du Nord St Denis
• Germany
  • Bad Neustadt An Der Saale, Germany, 97616
    • Herz- und Gefäß-Klinik GmbH Bad Neustadt
  • Essen, Germany, 45147
    • Westdeutsches Herzcentrum Uniklinik Essen
  • Nürenberg, Germany, 90471
    • Klinikum Nürnberg Süd
• Italy
  • Bari, Italy, 70124
    • Clínica Santa María
  • Catanzaro, Italy, 88100
    • S. Anna Hospital
  • Massa, Italy, 54100
    • G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation
  • Milan, Italy, 20138
    • Centro Cardiologico Monzino
  • Milan, Italy, 20162
    • Ospedale Niguarda Ca' Granda
  • Roma, Italy, 00168
    • Università Cattolica del Sacro Cuore Policlinico
  • Udine, Italy, 33100
    • Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"
• Netherlands
  • Eindhoven, Netherlands, 5623
    • Catharina Hospital Eindhoven
• Spain
  • Barakaldo, Spain, 48903
    • Hospital Universitario Cruces Barakaldo
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Universitario Virgen de la Arrixaca
• Switzerland
  • Bern, Switzerland, 3010
    • Universitätsklinik Für Herz und Gefässchirurgie
  • Lugano, Switzerland, 6903
    • Cardiocentro Ticino
  • Zurich, Switzerland, 8091
    • Universität Zürich
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, SE1 7EH
    • St Thomas' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's Average 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.	At time of surgery; an average of 1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's Average Time 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.	At time of surgery; an average of 1.5 hours
Subject's Average Skin-to-skin Time	The time from start of skin incision to end of skin closure.	At time of surgery; an average of 3.5 hours
Subject's Device Technical Success	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.	At time of surgery
Subject's Average Health Care Utilization	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.	Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively.
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline	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.	30 days, 3 months, 1 year, 2 years
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time	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.	Baseline, 3 months
Subject's Average Mean Gradient Measurements	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.	Baseline, discharge, 3 months, and 1 year
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.	Baseline, discharge, 3 months, and 1 year
Subject's Average Effective Orifice Area Measurements	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.	Baseline, discharge, 3 months, 1 year
Subject's Average Effective Orifice Area Index (EOAI) Measurements	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.	Baseline, Discharge, 3 months, 1 year
Subject's Average Performance Index Measurements	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.	Discharge, 3 Months, 1 Year
Subject's Average Left Ventricular Ejection Fraction (LVEF)	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%.	Baseline, discharge, 3 months, 1 year
Subject's Amount of Aortic Valvular Regurgitation Over Time.	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.	Discharge, 3 months, 1 year
Subject's Amount of Paravalvular Leak Over Time.	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.	Discharge, 3 months, 1 year
Subject's Average Cardiac Output Over Time	The amount of blood the heart pumps through the circulatory system in a minute.	Discharge, 3 months, 1 year
Subject's Average Cardiac Output Index	A hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA).	Discharge, 3 Months, 1 Year
Subject's Average Left Ventricular End-Diastolic Dimension	The measurement of the heart's left ventricle at end diastole.	Baseline, Discharge, 3 Months, 1 Year
Subject's Average Left Ventricular End-Systolic Dimension	The measurement of the heart's left ventricle at end systole.	Baseline, Discharge, 3 Months, 1 Year
Left Ventricular End-diastolic Volume (LVEDV)	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.	Baseline, Discharge, 3 Months, 1 Year
Left Ventricular End-systolic Volume (LVESV)	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.	Baseline, Discharge, 3 Months, 1 Year
Percentage of Subjects With Early Adverse Events	Number of Subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.	Events occurring within 30 days of procedure
Percentage of Late Adverse Events Divided by Late Patient Years	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).	Events occurring >= 31 days and up through 2 years post-implant

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: 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

Publications and helpful links

General Publications

• Young C, Laufer G, Kocher A, Solinas M, Alamanni F, Polvani G, Podesser BK, Aramendi JI, Arribas J, Bouchot O, Livi U, Massetti M, Terp K, Giot C, Glauber M. One-year outcomes after rapid-deployment aortic valve replacement. J Thorac Cardiovasc Surg. 2018 Feb;155(2):575-585. doi: 10.1016/j.jtcvs.2017.09.133. Epub 2017 Oct 31.

Helpful Links

• EuroQol Standardized Instrument (EQ-5D) developed to measure of health-related quality of life

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 19, 2014
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Aortic Valve Replacement; EDWARDS INTUITY
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Disease
• Other Study ID Numbers: 2011-13 (ICIRC)