Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis With Insufficiency
- Sponsor
- Edwards Lifesciences
- Enrollment
- 295
- Locations
- 6
- Primary Endpoint
- Percent of Early Adverse Events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Percent of Early Adverse Events
Time Frame: Events occuring within 30 days of procedure
Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Percent of Late Adverse Events
Time Frame: Events occurring >= 31 days and up through 5 years post-implant
Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).