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

Not Applicable

Active, not recruiting

• Conditions: Symptomatic Aortic Stenosis; Aortic Stenosis; Severe Aortic Valve Stenosis; Aortic Valve Calcification
• Interventions: Device: DurAVRTM THV System

• Registration Number: NCT05712161
• Lead Sponsor: Anteris Technologies Ltd.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-03
• Study Start: 2023-08-07
• Primary Completion: 2023-12-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DurAVR™ THV System	DurAVRTM THV System	TAVR procedure

Primary Outcome Measures

Name	Time	Method
Technical success	Immediate post procedure	Freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device.
All-cause mortality or disabling stroke	30days	Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines

Secondary Outcome Measures

Name	Time	Method
Major vascular, access-related, or cardiac structural complication	30days	complications according to VARC-3 Guidelines
All-cause mortality	30days	Mortality would be reported as rate of death/mortality at 30days.
VARC-3 Type 2-4 bleeding	30days	Rates of Type 2, 3, and 4 bleeding according to VARC-3 guidelines
Acute Kidney Injury stage 3 or 4	30days	AKI stage 3-4 according to VARC-3 guidelines
Moderate or severe aortic regurgitation	30days	aortic regurgitation according to VARC-3 guidelines
New permanent pacemaker due to procedure related conduction abnormalities	30days	Rate of pacemaker interventions in subjects experiencing conduction abnormalities
Disabling stroke	30days	Rate of disabling stroke according to VARC-3 Guidelines
Surgery or intervention related to the device, including aortic valve reintervention.	30days	Device related interventions

Trial Locations

Locations (5)

Columbia University Medical Center/NYPH; 🇺🇸 New York, New York, United States

Tucson Medical Center; 🇺🇸 Tucson, Arizona, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States