The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2017
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.
- Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System
- Aortic Valve bioprosthesis
Arms, Groups and Cohorts
- Other: Study Valve
- Subjects act as own control
Clinical Trial Outcome Measures
- 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).
Participating in This Clinical Trial
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 Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Edwards Lifesciences
- Provider of Information About this Clinical Study
- Overall Official(s)
- Prof Axel Haverich, Study Director, MHH Hannover
Citations Reporting on Results
Laufer G, Haverich A, Andreas M, Mohr FW, Walther T, Shrestha M, Rahmanian P, Holzhey D, Roth M, Schmitz C, Schramm R, Giot C, Wahlers TCW. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg. 2017 Aug 1;52(2):281-287. doi: 10.1093/ejcts/ezx103.
Haverich A, Wahlers TC, Borger MA, Shrestha M, Kocher AA, Walther T, Roth M, Misfeld M, Mohr FW, Kempfert J, Dohmen PM, Schmitz C, Rahmanian P, Wiedemann D, Duhay FG, Laufer G. Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2854-60. doi: 10.1016/j.jtcvs.2014.07.049. Epub 2014 Aug 1.
Kocher AA, Laufer G, Haverich A, Shrestha M, Walther T, Misfeld M, Kempfert J, Gillam L, Schmitz C, Wahlers TC, Wippermann J, Mohr FW, Roth M, Skwara A, Rahmanian P, Wiedemann D, Borger MA. One-year outcomes of the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. J Thorac Cardiovasc Surg. 2013 Jan;145(1):110-5; discussion 115-6. doi: 10.1016/j.jtcvs.2012.07.108. Epub 2012 Oct 8.
Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509.
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