DurAVR™ THV System: First-In-Human Study

Symptomatic Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05182307
• Other study ID #: SP0011
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Anteris Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Calcification
• Aortic Valve Stenosis
• Constriction, Pathologic
• Severe Aortic Valve Stenosis
• Symptomatic Aortic Stenosis

Intervention

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

Locations

Country	Name	City	State
Georgia	Tbilisi Heart and Vascular Clinic Ltd	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Anteris Technologies Ltd.

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DurAVR™ THV System ease of use	DurAVR™ THV System ease of use (Questionnaire)	Intra-operative
Other	Adverse Events	VARC-3 defined adverse events	Throughout the entire study, up to 1 year.
Primary	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
Primary	Hemodynamic performance	Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI)	Immediate post procedure
Primary	All-cause mortality	All-cause mortality	30 days
Primary	All-cause mortality	All-cause mortality	1 year
Primary	Myocardial infarction	Myocardial infarction	30 days
Primary	Myocardial infarction	Myocardial infarction	1 year
Primary	Stroke	Disabling Stroke (VARC-3 Guidelines)	30 days
Primary	Stroke	Disabling Stroke (VARC-3 Guidelines)	1 year
Primary	Life-threatening bleeding	Life-threatening bleeding (VARC-3 Guidelines)	30 days
Primary	Life-threatening bleeding	Life-threatening bleeding (VARC-3 Guidelines)	1 year