Safety and Performance Study of the Optimum Transcatheter Aortic Valve

Trial details

Who runs it

Thubrikar Aortic Valve, Inc.

Trial code

NCT04076150

Record updated

21 September 2022

Original description

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 ImplantRead full original descriptionShow less

A First-in-Human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant

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

Inclusion: Willing and capable to provide informed consent; 70 years of age or older; Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve Effective Orifice Area (EAO) ≤ 1.0 cm2 or 0.6 cm2/m2, mean aortic valve gradient ≥35 mmHg or peak aortic valve velocity > 4 m/sec; Symptomatology due to native aortic stenosis resulting in a New York Heart Association (NYHA) functional classification of II or greater; Aortic valve annular diameter ≥ 21 and ≤ 23mm measured by MSCT (Multi-Slice Computed Tomography); A STS (Society of Thoracic Surgeons) score ≥ 8; or Logistic EuroScore I ≥ 15; or a determination by the local heart team that the co-morbidities not captured by the STS or EuroScore are expected to increase the operative mortality risk to > 15%; Geographically available and willing to comply with follow up.

Exclusion: Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months; *; Need for emergent surgery or intervention other than the investigational procedure; Currently participating in any other investigational drug or device study; Myocardial infarction within the past 30 days*; Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure; Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery; Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy; Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or small vessels) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT; Gastrointestinal bleeding within the past 30 days; *; Stroke or transient ischemic attack (TIA) within past 3 months;*; End stage renal disease requiring chronic dialysis; Active infection requiring ongoing treatment; Hypersensitivity or contraindication to procedural medication(s) and device material(s) (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated; Life expectancy < 1 year due to non-cardiac co-morbid conditions; Patient lacking capacity to provide informed consent (history of any cognitive or mental health status that would interfere with study participation); LVEF (Left Ventricular Ejection Fraction) < 30%; Renal insufficiency as demonstrated by a serum creatinine > 3.0 mg/dL; Subject found to have an International Normalized Ratio (INR) greater than 2.0 right before the procedure; At the time of procedure, if a subject's medical status has changed since enrollment, the subject shall be re-evaluated for eligibility; Congenital unicuspid or bicuspid aortic valve; Noncalcified aortic valve; Valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success; Severe (Grade 3 to 4) aortic, mitral, or tricuspid valve regurgitation; Moderate to severe mitral stenosis; Echocardiographic evidence of intracardiac mass, thrombus or vegetation; Patient ineligible for or refuses blood transfusions.

ClinicalTrials.gov NCT04076150