Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.

The primary objective is to assess the acute and long-term safety and feasibility of the DurAVR™ device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement as assessed by the Heart Team at the enrolling institutions.

This is a prospective, non-randomized, single-arm, multi-center Study. Subjects will be consented for follow-up to 10 years.

Inclusion Criteria:

• Subjects are eligible for entry in this study if ALL the following conditions are met:

  1. Symptomatic, severe native aortic stenosis in subjects 65 years or older
  2. Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
  3. Eligible for transfemoral delivery of the DurAVR™ THV
  4. Anatomy appropriate to accommodate safe placement of DurAVR™ THV (Preprocedural measurements by TTE and CT required: aortic annulus diameter 21-23 mm by CT)
  5. Understands the study requirements and the treatment procedures and provides written informed consent
  6. Subject agrees to complete all required scheduled follow-up visits.

Exclusion Criteria:

• Subjects are eligible for entry in this study if NONE of the following conditions are met:

Anatomical

1. Anatomy precluding safe placement of DurAVR™ THV

2. Pre-existing prosthetic heart valve in any position

3. Unicuspid or bicuspid aortic valve

4. Severe aortic regurgitation

5. Severe mitral or severe tricuspid regurgitation requiring intervention.

6. Moderate to severe mitral stenosis.

7. Hypertrophic obstructive cardiomyopathy

8. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.

9. Severe basal septal hypertrophy with outflow gradient

   Clinical

10. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.

11. Determined inoperable/ineligible for surgery by the Heart Team

12. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure

13. Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states

14. Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization

15. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support

16. Need for emergency surgery for any reason

17. Ventricular dysfunction with left ventricular ejection fraction (LVEF) < 30% as measured by resting echocardiogram

18. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).

19. Symptomatic carotid or vertebral artery disease

20. End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.

21. GI bleeding within the past 3 months

22. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, nitinol (titanium or nickel), ticlopidine and clopidogrel, contrast media

23. Ongoing sepsis, including active endocarditis (Duke Criteria) [49]

24. Subject refuses a blood transfusion

25. Life expectancy < 12 months due to associated non-cardiac co-morbid conditions

26. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent

27. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)

28. Currently participating in an investigational drug or another investigational device trial

29. Subject is contraindicated for MDCT or MRI Scans.

30. Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).