Trial Search Results

Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Edwards Lifesciences

Stanford Investigator(s):

Intervention(s):

  • Device: EDWARDS INTUITY valve

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Inclusion Criteria - Subjects will be required to meet all inclusion criteria:

      1. Male or female, age 18 years or older

      2. Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a
      planned replace-ment as indicated in the preoperative evaluation

      3. Is scheduled to undergo planned aortic valve replacement with or without
      concomitant coronary bypass surgery

      4. Provide written informed consent

      5. Geographically stable and agrees to attend follow-up assessments until all
      subjects have completed 5 years of follow up

Exclusion Criteria:

   - Exclusion Criteria - Subjects will not be eligible for trial participation if any of
   the following criteria are present:

      1. Pure aortic insufficiency

      2. Requires emergency surgery

      3. Previous aortic valve replacement

      4. 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

      5. Requires multiple valve replacement/repair

      6. Requires a surgical procedure outside of the cardiac area (e.g., vascular
      endarterectomy, vascular bypass, tumor removal)

      7. Aneurysm of the aortic root and/or ascending aorta requiring surgical
      intervention

      8. Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months
      prior to the scheduled AVR surgery

      9. Myocardial infarction (MI) within thirty (30) days prior to valve replacement
      surgery

   10. Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or
      end-stage renal disease requiring chronic dialysis

   11. Hyperparathyroidism

   12. MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic
      attack (TIA) within 6 months (180 days) of the procedure

   13. Presence of non-cardiac disease limiting life expectancy to less than 12 months

   14. Hypertrophic obstructive cardiomyopathy (HOCM)

   15. Left ventricular ejection fraction ≤ 25%

   16. Documented history of substance (drug or alcohol) abuse within the last 5 years

   17. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation

   18. Hemodynamic or respiratory instability requiring inotropic support, mechanical
      circulatory support, or mechanical ventilation within 30 days prior to the
      procedure

   19. Pregnancy, lactation, or planning to become pregnant;

   20. Currently incarcerated or unable to give voluntary informed consent

   21. Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L),
      or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding
      diathesis or coagulopathy

   22. History of myxomatous disease/connective tissue disorders (e.g., Marfan's
      Syndrome)

   23. Current or recent participation (within 6 weeks prior to surgery) in an
      investigational drug or device trial

      _____

      Intra-operative Exclusion Criteria

   24. Anatomic variances which contraindicate implant of the trial valve, such as:

         1. anomalous coronary arteries

         2. annular deformation or extensive calcification of the annulus or aortic root
         which cannot be removed

         3. significant calcium on the anterior mitral leaflet

         4. pronounced septal calcification

         5. position of coronary ostia relative to Model 8300ACD valve that would result
         in obstruction of blood flow

   25. Available devices are not suitably sized for the subject's annulus

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Fidelis F Sabalvaro, CCRP
650-498-1232
Recruiting