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

Aortic Stenosis Clinical Trial

— DurAVR™ EFS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05712161
• Other study ID #: SP0028
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: December 2033

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2033
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Device:
• DurAVRTM THV System
The DurAVR™ Transcatheter Heart Valve (THV) is a balloon expandable transcatheter aortic valve

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Montefiore Medical Center	Bronx	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Tucson Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Anteris Technologies Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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