Clinical trial NCT02338154: EDWARDS INTUITY Valve System FOUNDATION Study
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Aortic Stenosis
Rapid Deployment Valves
Keywords: Aortic Valve Replacement
Aortic Stenosis
EDWARDS INTUITY
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Subject's Average Time Spent on Cardiopulmonary Cross Clamp
timeFrame: At time of surgery; an average of 1 hour
Secondary outcomes:
Other outcomes:
measure: Subject's Average Time Spent on Cardiopulmonary Bypass
timeFrame: At time of surgery; an average of 1.5 hours
measure: Subject's Average Skin-to-skin Time
timeFrame: At time of surgery; an average of 3.5 hours
measure: Subject's Device Technical Success
timeFrame: At time of surgery
measure: Subject's Average Health Care Utilization
timeFrame: Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively.
measure: Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
timeFrame: 30 days, 3 months, 1 year, 2 years
measure: Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
timeFrame: Baseline, 3 months
measure: Subject's Average Mean Gradient Measurements
timeFrame: Baseline, discharge, 3 months, and 1 year
measure: Subject's Average Peak Gradients (mmHg) Measurements Over Time
timeFrame: Baseline, discharge, 3 months, and 1 year
measure: Subject's Average Effective Orifice Area Measurements
timeFrame: Baseline, discharge, 3 months, 1 year
measure: Subject's Average Effective Orifice Area Index (EOAI) Measurements
timeFrame: Baseline, Discharge, 3 months, 1 year
measure: Subject's Average Performance Index Measurements
timeFrame: Discharge, 3 Months, 1 Year
measure: Subject's Average Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline, discharge, 3 months, 1 year
measure: Subject's Amount of Aortic Valvular Regurgitation Over Time.
timeFrame: Discharge, 3 months, 1 year
measure: Subject's Amount of Paravalvular Leak Over Time.
timeFrame: Discharge, 3 months, 1 year
measure: Subject's Average Cardiac Output Over Time
timeFrame: Discharge, 3 months, 1 year
measure: Subject's Average Cardiac Output Index
timeFrame: Discharge, 3 Months, 1 Year
measure: Subject's Average Left Ventricular End-Diastolic Dimension
timeFrame: Baseline, Discharge, 3 Months, 1 Year
measure: Subject's Average Left Ventricular End-Systolic Dimension
timeFrame: Baseline, Discharge, 3 Months, 1 Year
measure: Left Ventricular End-diastolic Volume (LVEDV)
timeFrame: Baseline, Discharge, 3 Months, 1 Year
measure: Left Ventricular End-systolic Volume (LVESV)
timeFrame: Baseline, Discharge, 3 Months, 1 Year
measure: Percentage of Subjects With Early Adverse Events
timeFrame: Events occurring within 30 days of procedure
measure: Percentage of Late Adverse Events Divided by Late Patient Years
timeFrame: Events occurring >= 31 days and up through 2 years post-implant
Locations:
city: Salzburg
country: Austria
facility: Salzburger Universitätsklinikum
city: St Pölten
country: Austria
facility: Landesklinikum - St. Pölten
city: Vienna
country: Austria
facility: Klinisshe Abteiluing Für Herz-thoraxchirurgie
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Skejby
city: Dijon
country: France
facility: CHU Bocage Central Dijon
city: Marseille Cedex
country: France
facility: Hôpital Saint Joseph - Marseille
city: Mulhouse Cedex
country: France
facility: Centre Hospitalier de Mulhouse
city: St Denis
country: France
facility: Centre Cardiologique du Nord St Denis
city: Bad Neustadt An Der Saale
country: Germany
facility: Herz- und Gefäß-Klinik GmbH Bad Neustadt
city: Essen
country: Germany
facility: Westdeutsches Herzcentrum Uniklinik Essen
city: Nürenberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Bari
country: Italy
facility: Clinica Santa Maria
city: Catanzaro
country: Italy
facility: S. Anna Hospital
city: Massa
country: Italy
facility: G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Milan
country: Italy
facility: Ospedale Niguarda Ca' Granda
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore Policlinico
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"
city: Eindhoven
country: Netherlands
facility: Catharina Hospital Eindhoven
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces Barakaldo
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Bern
country: Switzerland
facility: Universitätsklinik Für Herz und Gefässchirurgie
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Zurich
country: Switzerland
facility: Universität Zurich
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Organizational Affiliation: OSPEDALE "G. PASQUINUCCI" CREAS IFC-CNR
name: Dr. Glauber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guy's & St Thomas' Hospital
name: Prof.Christopher Young, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.