Clinical trial NCT02907463: EDWARDS INTUITY Elite Valve System
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Aortic Stenosis
Keywords: Aortic Valve Replacement
Aortic Stenosis
EDWARDS INTUITY Elite
Rapid deployment valves
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Adult subjects, age18 or older, that have been diagnosed with aortic stenosis or stenosis-based insufficiency requiring isolated aortic valve replacement (AVR)
* Subjects whose medical records indicate they are a suitable candidate for Minimally Invasive Surgery (MIS)
* Subjects whose treating physician is the Principle Investigator or a Sub-Investigator participating in the study and has been trained on the EDWARDS INTUITY Elite Valve System
* Subject shall be drawn from the general patient population served by each investigational center
* Candidates for this study must meet all of the following Inclusion criteria and none of the Exclusion criteria or intra-op exclusion criteria

Brief 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subject's Average Time Spent on Cardiopulmonary Cross Clamp
timeFrame: At time of surgery; an average of 1 hour
Secondary outcomes:
measure: Subject's Average Time Spent on Cardiopulmonary Bypass.
timeFrame: At time of surgery; an average of 1.5 hours
measure: Device Technical Success Rate
timeFrame: At time of surgery
measure: First Attempt Success Rate
timeFrame: At time of surgery
measure: Procedural Success
timeFrame: Day of procedure and events occurring within 10 days of procedure
measure: Subject's Average Health Care Utilization
timeFrame: Day of surgical procedure through discharge from the hospital, an average of 3 days and 10 days respectively.
measure: Subject's Average Mean Gradient Measurements Over Time.
timeFrame: Baseline, Discharge and 6 months
measure: Subject's Average Peak Gradients Measurements Over Time.
timeFrame: Baseline, Discharge and 6 months
measure: Subject's Average Effective Orifice Area (EOA) Measurements Over Time
timeFrame: Baseline, Discharge and 6 months
measure: Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time.
timeFrame: Discharge and 6 months
measure: Subject's Average Performance Index Measurements Over Time.
timeFrame: Baseline, Discharge and 6 months
measure: Subject's Average Cardiac Output Over Time
timeFrame: Baseline, Discharge and 6 months
measure: Subject's Average Cardiac Index
timeFrame: Discharge and 6 months
measure: Subject's Amount of Paravalvular Leak Over Time.
timeFrame: Discharge and 6 months
measure: Subject's Amount of Aortic Valvular Regurgitation Over Time.
timeFrame: Discharge and 6 Months
Other outcomes:
measure: Subject's Average SF-36 Physical Health Summary
timeFrame: Baseline and 6 months
measure: Subject's Average SF-36 Mental Health Summary
timeFrame: Baseline and 6 months
measure: Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
timeFrame: 6 months compared to baseline
measure: Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time
timeFrame: Baseline and 6 months
measure: Subject's Average Fitness for Hospital Discharge
timeFrame: Day of surgical procedure through discharge from the hospital; an average of 7 days
measure: Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
timeFrame: Events occurring within 30 days of procedure
measure: Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
timeFrame: Events occuring >= 31 days and up through 6 months
Locations:
city: Innsbruck
country: Austria
facility: Universitätsklinik für Herzchirurgie Medizinische Universität Innsbruck
city: Vienna
country: Austria
facility: Klinisshe Abteiluing Für Herz-thoraxchirurgie
city: Aarhus N
country: Denmark
facility: Aarhus Universitets Hospital Skejby
city: Dijon
country: France
facility: CHU Bocage Central Dijon
city: Pessac Cedex
country: France
facility: Hôpital Cardiologique CHU Bordeaux Haut Leveque
city: Bad Neustadt An Der Saale
country: Germany
facility: Herz- und Gefäß-Klinik GmbH Bad Neustadt
city: Bochum
country: Germany
facility: Universitätsklinikum der Ruhr-Universität Bochum Klinik für Herz- und Thoraxchirurgie
city: Cologne
country: Germany
facility: Herzzentrum Uniklinik Köln
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Wurzburg
country: Germany
facility: University Hospital Würzburg
city: Massa
country: Italy
facility: G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation
city: Milan
country: Italy
facility: CentroCardiologico Monzino
city: Novara
country: Italy
facility: Clinica San Gaudenzio
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore Policlinico
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"
city: Luxembourg
country: Luxembourg
facility: Institut National de Chirurgie Cardiaque et Cardiologie Interventionnelle (INCCI)
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: La Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary Hospital Edinburgh
city: London
country: United Kingdom
facility: St Thomas' Hospital
Study officials:
affiliation: St. Thomas' Hospital
name: Christopher Young, MD FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: AKH Vienna Dep. of Cardiovascular Surgery
name: Gunther Laufer, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laufer G, Strauch JT, Terp KA, Salinas M, Arribas JM, Massetti M, Andreas M, Young CP. Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system. Interact Cardiovasc Thorac Surg. 2022 Jul 9;35(2):ivac083. doi: 10.1093/icvts/ivac083.