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

• ClinicalTrials.gov Identifier: NCT05712161
• Recruitment Status: Active, not recruiting
• First Posted: February 3, 2023
• Last Update Posted: January 31, 2024
• Sponsor: Anteris Technologies Ltd.
• Information provided by (Responsible Party): Anteris Technologies Ltd.

Tracking Information

• First Submitted Date: January 13, 2023
• First Posted Date: February 3, 2023
• Last Update Posted Date: January 31, 2024
• Actual Study Start Date: August 7, 2023
• Actual Primary Completion Date: December 29, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 25, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 25, 2023)

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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: January 25, 2023)

• Hospitalization (or re-hospitalization) [ Time Frame: 1 year ]
  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.
• Leaflet thickening and reduced motion [ Time Frame: 1year ]
  Assessing causes of valve leaflet thickening and reduced leaflet motion such as leaflet thrombosis, endocarditis, leaflet deterioration, and valve frame expansion issues.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
• Official Title: Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

A prospective, non-randomized, single-arm, multi-center study

Masking: None (Open Label)
Primary Purpose: Device Feasibility

Condition

• Aortic Stenosis
• Symptomatic Aortic Stenosis
• Severe Aortic Valve Stenosis
• Aortic Valve Calcification

Intervention

Device: DurAVRTM THV System

The DurAVR™ Transcatheter Heart Valve (THV) is a balloon expandable transcatheter aortic valve

Study Arms

Experimental: DurAVR™ THV System

TAVR procedure

Intervention: Device: DurAVRTM THV System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 25, 2023): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2033
• Actual Primary Completion Date: December 29, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05712161
• Other Study ID Numbers: SP0028
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Anteris Technologies Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Anteris Technologies Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Michael Reardon, MD; Methodist DeBakey Hospital

• PRS Account: Anteris Technologies Ltd.
• Verification Date: January 2024