Clinical trial NCT05712161: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Symptomatic Aortic Stenosis
Severe Aortic Valve Stenosis
Aortic Valve Calcification
Keywords: TAVI
TAVR
Transcatheter Valve
Transcatheter Aortic Valve Implantation
Lead sponsor: Anteris Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, non-randomized, single-arm, multi-center study
Primary purpose: DEVICE_FEASIBILITY

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.

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).

Primary outcomes:
measure: All-cause mortality or disabling stroke
timeFrame: 30days
measure: Technical success
timeFrame: Immediate post procedure
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30days
measure: Disabling stroke
timeFrame: 30days
measure: Major vascular, access-related, or cardiac structural complication
timeFrame: 30days
measure: VARC-3 Type 2-4 bleeding
timeFrame: 30days
measure: Acute Kidney Injury stage 3 or 4
timeFrame: 30days
measure: Moderate or severe aortic regurgitation
timeFrame: 30days
measure: New permanent pacemaker due to procedure related conduction abnormalities
timeFrame: 30days
measure: Surgery or intervention related to the device, including aortic valve reintervention.
timeFrame: 30days
Other outcomes:
measure: Hospitalization (or re-hospitalization)
timeFrame: 1 year
measure: Leaflet thickening and reduced motion
timeFrame: 1year
Locations:
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Methodist DeBakey Hospital
name: Michael Reardon, MD
role: STUDY_CHAIR
References: