Actively Recruiting
Safety and Performance Study of the Optimum Transcatheter Aortic Valve
Led by Thubrikar Aortic Valve, Inc. · Updated on 2022-09-21
5
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
T
Thubrikar Aortic Valve, Inc.
Lead Sponsor
K
KCRI
Collaborating Sponsor
AI-Summary
What this Trial Is About
The TAVI (Thubrikar Aortic Valve, Inc.) -1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant
CONDITIONS
Official Title
Safety and Performance Study of the Optimum Transcatheter Aortic Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and capable to provide informed consent
- 70 years of age or older
- Echocardiographic or hemodynamic evidence of calcific (senile) aortic stenosis with either an aortic valve Effective Orifice Area (EAO) 4 1.0 cm2 or 0.6 cm2/m2, mean aortic valve gradient 35 mmHg or peak aortic valve velocity > 4 m/sec
- Symptoms due to native aortic stenosis with New York Heart Association (NYHA) functional classification of II or greater
- Aortic valve annular diameter 4 21 and 3 23 mm measured by Multi-Slice Computed Tomography (MSCT)
- STS score 4 8; or Logistic EuroScore I 4 15; or local heart team assessment indicating operative mortality risk > 15%
- Geographically available and willing to comply with follow up
You will not qualify if you...
- Congenital unicuspid or bicuspid aortic valve
- Noncalcified aortic valve
- Valve eccentricity that could compromise procedural success
- Severe (Grade 3 to 4) aortic, mitral, or tricuspid valve regurgitation
- Moderate to severe mitral stenosis
- Myocardial infarction within the past 30 days
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Left Ventricular Ejection Fraction (LVEF) < 30%
- Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
- Hemodynamic instability requiring inotropic drug therapy within past 14 days or mechanical support within past 6 months
- Significant aortic disease such as atheroma, thrombus, or aneurysm that precludes safe implant delivery
- Blood disorders including acute leukopenia, anemia, thrombocytopenia, bleeding history or coagulopathy
- Ineligible for or refuses blood transfusions
- Unfavorable peripheral vascular anatomy or disease preventing catheter passage from femoral artery to aorta
- Gastrointestinal bleeding within past 30 days
- Stroke or transient ischemic attack within past 3 months
- Renal insufficiency with serum creatinine > 3.0 mg/dL
- End-stage renal disease requiring dialysis
- Active infection needing treatment
- Need for emergency surgery or intervention other than investigational procedure
- Hypersensitivity or contraindication to procedural medications or device materials
- Life expectancy less than 1 year due to non-cardiac conditions
- Currently in other investigational drug or device studies
- Lacking capacity to provide informed consent due to cognitive or mental health issues
- International Normalized Ratio (INR) greater than 2.0 immediately before procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
John Paul II Hospital, Dept. of Interventional Cardiology
Krakow, Poland, 31-202
Actively Recruiting
Research Team
M
Mano Thubrikar, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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