DurAVR™ THV System: First-In-Human Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve.
The study will enroll up to 10 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment DurAVR™ THV System |
Device: DurAVR™ THV System
Transcatheter Aortic Valve Implantation (TAVI) Procedure
|
Outcome Measures
Primary Outcome Measures
- DurAVR™ prosthetic heart valve implant [Immediate post procedure]
Number of subjects for which a single DurAVR™ prosthetic heart valve was correctly positioned into the proper anatomical location
- Hemodynamic performance [Immediate post procedure]
Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI)
- All-cause mortality [30 days]
All-cause mortality
- All-cause mortality [1 year]
All-cause mortality
- Myocardial infarction [30 days]
Myocardial infarction
- Myocardial infarction [1 year]
Myocardial infarction
- Stroke [30 days]
Disabling Stroke (VARC-3 Guidelines)
- Stroke [1 year]
Disabling Stroke (VARC-3 Guidelines)
- Life-threatening bleeding [30 days]
Life-threatening bleeding (VARC-3 Guidelines)
- Life-threatening bleeding [1 year]
Life-threatening bleeding (VARC-3 Guidelines)
Other Outcome Measures
- DurAVR™ THV System ease of use [Intra-operative]
DurAVR™ THV System ease of use (Questionnaire)
- Adverse Events [Throughout the entire study, up to 1 year.]
VARC-3 defined adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Symptomatic, severe aortic stenosis
-
Eligible for delivery of the DurAVR™ THV
-
Anatomy appropriate to accommodate safe placement of DurAVR™ THV
-
Understands the study requirements and the treatment procedures and provides written informed consent.
-
Subject agrees to complete all required scheduled follow-up visits.
Exclusion Criteria:
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 < 1000mm3), 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) ≤ 40% 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
-
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 belongs to a vulnerable population.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tbilisi Heart and Vascular Clinic Ltd | Tbilisi | Georgia |
Sponsors and Collaborators
- Admedus Regen Pty Ltd.
Investigators
- Study Director: Chris Meduri, MD, Anteris Technologies
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SP0011