DurAVR™ THV System: First-In-Human Study

Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: First In Human Study

A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.

Study Overview

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

Detailed Description

The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve.

The study will enroll up to 25 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Tbilisi Heart and Vascular Clinic LTD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Symptomatic, severe aortic stenosis
2. Eligible for delivery of the DurAVR™ THV
3. Anatomy appropriate to accommodate safe placement of DurAVR™ THV
4. Understands the study requirements and the treatment procedures and provides written informed consent.
5. Subject agrees to complete all required scheduled follow-up visits.

Exclusion Criteria:

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 < 1000mm3), 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) ≤ 40% 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
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 belongs to a vulnerable population.

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: Treatment; DurAVR™ THV System	Device: DurAVR™ THV System; Transcatheter Aortic Valve Implantation (TAVI) Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	30 days
DurAVR™ prosthetic heart valve implant	Number of subjects for which a single DurAVR™ prosthetic heart valve was correctly positioned into the proper anatomical location	Immediate post procedure
Hemodynamic performance	Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI)	Immediate post procedure
All-cause mortality	All-cause mortality	1 year
Myocardial infarction	Myocardial infarction	30 days
Myocardial infarction	Myocardial infarction	1 year
Stroke	Disabling Stroke (VARC-3 Guidelines)	30 days
Stroke	Disabling Stroke (VARC-3 Guidelines)	1 year
Life-threatening bleeding	Life-threatening bleeding (VARC-3 Guidelines)	30 days
Life-threatening bleeding	Life-threatening bleeding (VARC-3 Guidelines)	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
DurAVR™ THV System ease of use	DurAVR™ THV System ease of use (Questionnaire)	Intra-operative
Adverse Events	VARC-3 defined adverse events	Throughout the entire study, up to 1 year.

Collaborators and Investigators

• Sponsor: Anteris Technologies Ltd.
• Investigators: Study Director: Chris Meduri, MD, Anteris Technologies

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: TAVI; TAVR; Transcatheter Aortic Valve Implantation; Transcatheter valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: SP0011

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: No
• product manufactured in and exported from the U.S.: Yes