EDWARDS INTUITY Elite Valve System

Aortic Stenosis Clinical Trial

— MISSION  

Official title:

Assessing Clinical Outcomes Using the EDWARDS INTUITY Elite Valve System in Isolated AVR Using Minimally InvaSive Surgery In a EurOpean Multi-ceNter, Active, Post-market Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907463
• Other study ID #: 2015-05
• Status: Completed
• Start date: February 2016
• Est. completion date: December 2017

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, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.

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 Elite 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 Elite Valve System, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB; 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 Elite 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: 280
• Est. completion date: December 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is 18 years or older

2. Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.

3. Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.

4. Surgery is intended to be completed with an EDWARDS INTUITY Elite Heart Valve.

5. Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.

6. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.

Exclusion Criteria:

1. Subject is diagnosed with pure aortic insufficiency.

2. Subject requires multiple valve replacement/repair

3. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.

4. Subject has severe ventricular dysfunction defined as LVEF < 25%.

5. Subject has a history of active endocarditis and/or myocarditis = 3 months before the intended treatment/scheduled surgery.

6. Subject has had an acute MI = 3 months before the intended treatment.

7. Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.

8. Subject is oxygen or ventilator dependent.

9. Subject has life expectancy < 12 months.

10. Female subject is pregnant or lactating.

11. Subject with documented leukopenia (WBC < 3.5x 103/µL), anemia (Hb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy.

12. Subject has renal insufficiency as determined by Serum creatinine

= 200 µmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis.

13. Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed.

14. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition.

15. Aneurysm of the aortic root and/or ascending aorta

Intra-operative exclusion criteria:

1. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve. (A non-congenital bicuspid valve without a distorted annulus would not be cause for exclusion.)

2. Subject has calcium on the anterior mitral leaflet which cannot be removed.

3. Subject has extensive calcification of the aortic root.

4. Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus.

5. The position of the coronary ostia relative to the EDWARDS INTUITY Elite Aortic Valve could result in obstruction of blood flow.

6. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other condition (including patient switched to a full sternotomy approach).

7. The device is not available in the correct size for the subject.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Disease
• Aortic Valve Stenosis

Locations

Country	Name	City	State
Austria	Universitätsklinik für Herzchirurgie Medizinische Universität Innsbruck	Innsbruck
Austria	Klinisshe Abteiluing Für Herz-thoraxchirurgie	Vienna
Denmark	Aarhus Universitets Hospital Skejby	Aarhus N
France	CHU Bocage Central Dijon	Dijon
France	Hôpital Cardiologique CHU Bordeaux Haut Leveque	Pessac Cedex
Germany	Herz- und Gefäß-Klinik GmbH Bad Neustadt	Bad Neustadt An Der Saale
Germany	Universitätsklinikum der Ruhr-Universität Bochum Klinik für Herz- und Thoraxchirurgie	Bochum
Germany	Herzzentrum Uniklinik Köln	Cologne
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Herzzentrum Leipzig	Leipzig
Germany	University Hospital Würzburg	Wurzburg
Italy	G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation	Massa
Italy	CentroCardiologico Monzino	Milan
Italy	Clinica San Gaudenzio	Novara
Italy	Università Cattolica del Sacro Cuore Policlinico	Roma
Italy	Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"	Udine
Luxembourg	Institut National de Chirurgie Cardiaque et Cardiologie Interventionnelle (INCCI)	Luxembourg
Netherlands	St Antonius Hospital	Nieuwegein
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Complexo Hospitalario Universitario A Coruna	La Coruna
Spain	Hospital Clínico San Carlos	Madrid
United Kingdom	Royal Infirmary Hospital Edinburgh	Edinburgh
United Kingdom	St Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject's Average SF-36 Physical Health Summary	The Medical Outcomes Study Short-Form 36 - Physical Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.	Baseline and 6 months
Other	Subject's Average SF-36 Mental Health Summary	The Medical Outcomes Study Short-Form 36 - Mental Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.	Baseline and 6 months
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.	6 months compared to baseline
Other	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time	The EuroQol-5 Dimension (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 and 6 months
Other	Subject's Average Fitness for Hospital Discharge	Considered as the day at which the patient was fit for hospital discharge.	Day of surgical procedure through discharge from the hospital; an average of 7 days
Other	Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)	Number of 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	Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)	Number of late adverse events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).	Events occuring >= 31 days and up through 6 months
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
Secondary	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
Secondary	Device Technical Success Rate	The successful delivery and deployment of the EDWARDS INTUITY Elite valve and delivery system, and the subject leaving the operating room with valve in place.	At time of surgery
Secondary	First Attempt Success Rate	The successful delivery and deployment of the valve and delivery system during the first attempt, and subject leaving the operating room with EDWARDS INTUITY Elite valve in place.	At time of surgery
Secondary	Procedural Success	Procedural success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker (with baseline sinus rhythm and no other conduction issues), or subject death, within discharge or 10 days post index procedure whichever comes first.	Day of procedure and events occurring within 10 days of procedure
Secondary	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 hospital, an average of 3 days and 10 days respectively.
Secondary	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. Mean gradient values depend on the size and type of valve.	Baseline, Discharge and 6 months
Secondary	Subject's Average Peak Gradients 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 and 6 months
Secondary	Subject's Average Effective Orifice Area (EOA) Measurements 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.	Baseline, Discharge and 6 months
Secondary	Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time.	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.	Discharge and 6 months
Secondary	Subject's Average Performance Index Measurements Over Time.	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 pre-implant orifice area. Effective orifice area is evaluated by echocardiography over time.	Baseline, Discharge and 6 months
Secondary	Subject's Average Cardiac Output Over Time	The amount of blood the heart pumps through the circulatory system in a minute.	Baseline, Discharge and 6 months
Secondary	Subject's Average Cardiac Index	A measure of cardiac output per square meter of body surface area	Discharge and 6 months
Secondary	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 and 6 months
Secondary	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 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 and 6 Months

External Links

•   EuroQol Standardized Instrument (EQ-5D) developed to measure of health-related quality of life
•   New York Heart Association Classification
•   The Optum (SF-26v2) Health Survey questions to measure functional health and well-being from the patient's point of view