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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Stenosis; Aortic Valve Calcification; Severe Aortic Valve Stenosis; Symptomatic Aortic Stenosis
• Intervention / Treatment: Device: DurAVRTM THV System

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DurAVR™ THV System; TAVR procedure	Device: DurAVRTM THV System; The DurAVR™ Transcatheter Heart Valve (THV) is a balloon expandable transcatheter aortic valve

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization (or re-hospitalization)	Hospitalization (or re-hospitalization). Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay. Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition.	1 year
Leaflet thickening and reduced motion	Assessing causes of valve leaflet thickening and reduced leaflet motion such as leaflet thrombosis, endocarditis, leaflet deterioration, and valve frame expansion issues.	1year

Collaborators and Investigators

• Sponsor: Anteris Technologies Ltd.
• Investigators: Study Chair: Michael Reardon, MD, Methodist DeBakey Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: TAVI; TAVR; Transcatheter Aortic Valve Implantation; Transcatheter Valve
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve, Calcification of
• Other Study ID Numbers: SP0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes