EDWARDS INTUITY Valve System FOUNDATION Study

Aortic Stenosis Clinical Trial

— FOUNDATION  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338154
• Other study ID #: 2011-13
• Status: Completed
• Start date: July 2012
• Est. completion date: April 2016

Study information

• Verified date: November 2019
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Disease
• Aortic Valve Stenosis
• Rapid Deployment Valves

Locations

Country	Name	City	State
Austria	Salzburger Universitätsklinikum	Salzburg
Austria	Landesklinikum - St. Pölten	St Pölten
Austria	Klinisshe Abteiluing Für Herz-thoraxchirurgie	Vienna
Denmark	Aarhus Universitetshospital Skejby	Aarhus N
France	CHU Bocage Central Dijon	Dijon
France	Hôpital Saint Joseph - Marseille	Marseille Cedex
France	Centre Hospitalier de Mulhouse	Mulhouse Cedex
France	Centre Cardiologique du Nord St Denis	St Denis
Germany	Herz- und Gefäß-Klinik GmbH Bad Neustadt	Bad Neustadt An Der Saale
Germany	Westdeutsches Herzcentrum Uniklinik Essen	Essen
Germany	Klinikum Nürnberg Süd	Nürenberg
Italy	Clinica Santa Maria	Bari
Italy	S. Anna Hospital	Catanzaro
Italy	G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation	Massa
Italy	Centro Cardiologico Monzino	Milan
Italy	Ospedale Niguarda Ca' Granda	Milan
Italy	Università Cattolica del Sacro Cuore Policlinico	Roma
Italy	Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"	Udine
Netherlands	Catharina Hospital Eindhoven	Eindhoven
Spain	Hospital Universitario Cruces Barakaldo	Barakaldo
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Clínico San Carlos	Madrid
Switzerland	Universitätsklinik Für Herz und Gefässchirurgie	Bern
Switzerland	Cardiocentro Ticino	Lugano
Switzerland	Universität Zurich	Zurich
United Kingdom	King's College Hospital	London
United Kingdom	St Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Denmark,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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.
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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

External Links

•   EuroQol Standardized Instrument (EQ-5D) developed to measure of health-related quality of life
•   New York Heart Association Classification