A First-in-Human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Aortic Stenosis
- Sponsor
- Thubrikar Aortic Valve, Inc.
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Device Success
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Detailed Description
The purpose of the study is to assess the safety and performance of the Optimum TAV (Transcatheter Aortic Valve) in patients with symptomatic, severe aortic stenosis who are deemed high-risk for SAVR (Surgical Aortic Valve Replacement) or have contraindications or deemed inoperable for SAVR.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
- •Myocardial infarction within the past 30 days\*
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
- •LVEF (Left Ventricular Ejection Fraction) \< 30%;
- •Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure;
- •Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months; \*
Outcomes
Primary Outcomes
Device Success
Time Frame: 30 days
Valve deployed from delivery system successfully
Correct Positioning
Time Frame: 30 days
Deploying a single Optimum TAV in the intended anatomical position and confirming via fluoroscopy as determined by the implanting physician
Intended Performance of Optimum TAV - Leaflet Function
Time Frame: 30 days
Evaluate leaflet function by assessing the effective orifice area (EOA) (units: cm\^2) via echocardiography
Intended Performance of Optimum TAV - mean aortic valve gradient
Time Frame: 30 days
Evaluate hemodynamics by assessing the mean aortic valve gradient (units: mmHg) via echocardiography
Intended Performance of Optimum TAV - peak aortic valve velocity
Time Frame: 30 days
Evaluate hemodynamics by assessing the peak aortic valve velocity (units: m/s) via echocardiography
Intended Performance of Optimum TAV - Paravalvular Leak
Time Frame: 30 days
Evaluate proper valve sealing by assessing paravalvular leak via echocardiography and fluoroscopy. If paravalvular leak is determined, it will be classified as mild, moderate, or severe.