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

Anteris

Status

Active, not recruiting

Conditions

Severe Aortic Valve Stenosis

Symptomatic Aortic Stenosis

Aortic Stenosis

Aortic Valve Calcification

Treatments

Device: DurAVRTM THV System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05712161

SP0028

Details and patient eligibility

About

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

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Anatomy precluding safe placement of DurAVR™ THV
Pre-existing prosthetic heart valve in any position
Unicuspid or bicuspid aortic valve
Severe aortic regurgitation
Severe mitral or severe tricuspid regurgitation requiring intervention.
Moderate to severe mitral stenosis.
Hypertrophic obstructive cardiomyopathy
Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
Severe basal septal hypertrophy with outflow gradient

Clinical
Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
Determined inoperable/ineligible for surgery by the Heart Team
Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
Need for emergency surgery for any reason
Ventricular dysfunction with left ventricular ejection fraction (LVEF) < 30% as measured by resting echocardiogram
Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
Symptomatic carotid or vertebral artery disease
End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
GI bleeding within the past 3 months
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
Ongoing sepsis, including active endocarditis (Duke Criteria) [49]
Subject refuses a blood transfusion
Life expectancy < 12 months due to associated non-cardiac co-morbid conditions
Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent
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)
Currently participating in an investigational drug or another investigational device trial
Subject is contraindicated for MDCT or MRI Scans.
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).