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Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent

Description

Detailed Description
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After re-placement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually the-reafter for a minimum of five years.

Phase

N/A

Inclusion and Exclusion Criteria

  • - Inclusion Criteria - Subjects will be required to meet all inclusion criteria:
  • Male or female, age 18 years or older
  • Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replace-ment as indicated in the preoperative evaluation
  • Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery
  • Provide written informed consent
  • Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up

  • - Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present:
  • Pure aortic insufficiency
  • Requires emergency surgery
  • Previous aortic valve replacement
  • Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
  • Requires multiple valve replacement/repair
  • Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal)
  • Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
  • Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery
  • Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery
  • Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis
  • Hyperparathyroidism
  • MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure
  • Presence of non-cardiac disease limiting life expectancy to less than 12 months
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Left ventricular ejection fraction ≤ 25%
  • Documented history of substance (drug or alcohol) abuse within the last 5 years
  • Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure
  • Pregnancy, lactation, or planning to become pregnant;
  • Currently incarcerated or unable to give voluntary informed consent
  • Leucopenia (WBC < 3.5x 103/

Sites

Please contact Jose Escobar to learn more about where you can participate in this trial. Please use the contact form on the right side.
Presentado por SC CTSI