EDWARDS INTUITY Elite Valve System | NCT02907463

NCT02907463

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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
Device Technical Success Rate

Other Outcomes

Measure	Description	Time Frame
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
Subject's Average SF-36 Mental Health Summary

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is 18 years or older
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.
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.
Surgery is intended to be completed with an EDWARDS INTUITY Elite Heart Valve.
Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.
Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.

Exclusion Criteria:

Subject is diagnosed with pure aortic insufficiency.
Subject requires multiple valve replacement/repair
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.
Subject has severe ventricular dysfunction defined as LVEF < 25%.
Subject has a history of active endocarditis and/or myocarditis ≤ 3 months before the intended treatment/scheduled surgery.
Subject has had an acute MI ≤ 3 months before the intended treatment.
Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.
Subject is oxygen or ventilator dependent.
Subject has life expectancy < 12 months.
Female subject is pregnant or lactating.
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.
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.
Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed.
Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition.
Aneurysm of the aortic root and/or ascending aorta

Intra-operative exclusion criteria:

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.)
Subject has calcium on the anterior mitral leaflet which cannot be removed.
Subject has extensive calcification of the aortic root.
Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus.
The position of the coronary ostia relative to the EDWARDS INTUITY Elite Aortic Valve could result in obstruction of blood flow.
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).
The device is not available in the correct size for the subject.

Name	Affiliation	Role
Christopher Young, MD FRCS	St. Thomas' Hospital	Principal Investigator
Gunther Laufer, Prof. Dr. med	AKH Vienna Dep. of Cardiovascular Surgery	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinik für Herzchirurgie Medizinische Universität Innsbruck		Innsbruck		6020	Austria

PubMed Identifier	Type	Citation	Retractions
35394527	Derived	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.

ID	Title	Description
FG000	EDWARDS INTUITY Elite Valve System	The system includes the EDWARDS INTUITY Elite Aortic Valve, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB.

ID	Title	Description
BG000	Per Protocol Cohort	The per protocol cohort will consist of all enrolled patients that leave the operating room with the registry valve in place and had an AVR MIS surgery procedure.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Posted

Mean

Standard Deviation

minutes

At time of surgery; an average of 1 hour

ID	Title	Description
OG000	Per Protocol Cohort	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Per Protocol Cohort	The per protocol cohort will consist of all enrolled patients that leave the operating room with the registry valve in place and had an AVR MIS surgery procedure.

ID	Term
D000082862	Aortic Valve Disease
D001024	Aortic Valve Stenosis

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction