Brief Title
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
Official Title
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
Brief Summary
The purpose of this clinical investigation is to confirm that the safety and performance of
the EDWARDS INTUITY Valve System.
Detailed Description
This is a two-phase, non-randomized, prospective, single arm, multi-center clinical
investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All
subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1
month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per
subject.
Study Type
Interventional
Primary Outcome
Percent of Early Adverse Events
Condition
Aortic Valve Stenosis With Insufficiency
Intervention
Aortic Valve Replacement with EDWARDS INTUITY Valve System
Study Arms / Comparison Groups
Study Valve
Description: Subjects act as own control
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
295
Start Date
January 2010
Completion Date
December 2017
Primary Completion Date
December 2017
Eligibility Criteria
Criteria:
Inclusion Criteria:
- 18 years or older
- Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned
replacement as indicated in the preoperative evaluation;
- Scheduled to undergo planned aortic valve replacement with or without concomitant
coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or
atrial appendage occlusion/removal.
- Signed and dated the informed consent form prior to investigation procedures;
- Geographically stable and agrees to attend Follow up assessments at the hospital of
surgical services for a maximum of 5 years.
Exclusion Criteria:
- Pure aortic insufficiency
- Requires emergency surgery
- Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
- Left ventricular ejection fraction of ≤ 25%
- Active endocarditis within 3 months prior to the scheduled aortic valve replacement
surgery
- Concomitant valve (mitral, tricuspid, or pulmonic) disease requiring repair with an
annuloplasty ring or replacement with prosthesis
- Prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a
bioprosthetic valve, mechanical valve, or annuloplasty ring.
- Myocardial infarction (MI) within 1 month prior to the scheduled aortic valve
replacement surgery
- Previously implanted with EDWARDS INTUITY Aortic valve; alcohol or drug abuser
- Disease limiting life expectancy to less than 12 months
- Pregnant or lactating
- Currently participating in another drug or device clinical investigation;
- Documented blood diatheses
- Requires non-cardiac procedures such as carotid procedures or mediastinal tumor
removal
- Had a stroke or transient ischemic attack (TIA) within 6-months prior to scheduled
aortic valve replacement surgery
- Study site pre-operative echocardiographic assessment shows evidence of an
intracardiac mass, thrombus, or vegetation
- Hemodynamic or respiratory instability requiring inotropic support, mechanical
circulatory support, or mechanical ventilation within 30 days of procedure
- Documented renal insufficiency as determined by Serum creatinine ≥ 200 µmol/L (2.27
mg/dL) at screening or end-stage renal disease requiring chronic dialysis
- Documented hyperparathyroidism
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Prof Axel Haverich, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01445171
Organization ID
2009-01
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Prof Axel Haverich, Study Director, MHH Hannover
Verification Date
February 2020