Safety and Performance Study of the Optimum Transcatheter Aortic Valve
Primary Purpose
Severe Aortic Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System
Sponsored by
About this trial
This is an interventional device feasibility trial for Severe Aortic Stenosis
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; *
- 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;
- Patient ineligible for or refuses blood transfusions;
- 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;*
- Renal insufficiency as demonstrated by a serum creatinine > 3.0 mg/dL;
- End stage renal disease requiring chronic dialysis;
- Active infection requiring ongoing treatment;
- Need for emergent surgery or intervention other than the investigational procedure;
- 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;
- Currently participating in any other investigational drug or device study;
- Patient lacking capacity to provide informed consent (history of any cognitive or mental health status that would interfere with study participation)
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.
Sites / Locations
- John Paul II Hospital, Dept. of Interventional CardiologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients Receiving Optimum TAV
Arm Description
Patients with symptomatic severe aortic stenosis that will be treated via transcatheter aortic valve implantation procedure
Outcomes
Primary Outcome Measures
Device Success
Valve deployed from delivery system successfully
Correct Positioning
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
Evaluate leaflet function by assessing the effective orifice area (EOA) (units: cm^2) via echocardiography
Intended Performance of Optimum TAV - mean aortic valve gradient
Evaluate hemodynamics by assessing the mean aortic valve gradient (units: mmHg) via echocardiography
Intended Performance of Optimum TAV - peak aortic valve velocity
Evaluate hemodynamics by assessing the peak aortic valve velocity (units: m/s) via echocardiography
Intended Performance of Optimum TAV - Paravalvular Leak
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04076150
First Posted
August 9, 2019
Last Updated
September 14, 2022
Sponsor
Thubrikar Aortic Valve, Inc.
Collaborators
KCRI
1. Study Identification
Unique Protocol Identification Number
NCT04076150
Brief Title
Safety and Performance Study of the Optimum Transcatheter Aortic Valve
Official Title
A First-in-Human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
December 18, 2022 (Anticipated)
Study Completion Date
May 18, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thubrikar Aortic Valve, Inc.
Collaborators
KCRI
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Aortic Stenosis
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients Receiving Optimum TAV
Arm Type
Experimental
Arm Description
Patients with symptomatic severe aortic stenosis that will be treated via transcatheter aortic valve implantation procedure
Intervention Type
Device
Intervention Name(s)
Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System
Other Intervention Name(s)
Transcatheter Aortic Valve Replacement
Intervention Description
Treating patients with severe symptomatic aortic stenosis via transcatheter aortic valve implantation by implanting the Optimum TAV inside the native diseased valve via a the Precision Catheter. The Optimum TAV and Precision Catheter together are the Optimum TAV System.
Primary Outcome Measure Information:
Title
Device Success
Description
Valve deployed from delivery system successfully
Time Frame
30 days
Title
Correct Positioning
Description
Deploying a single Optimum TAV in the intended anatomical position and confirming via fluoroscopy as determined by the implanting physician
Time Frame
30 days
Title
Intended Performance of Optimum TAV - Leaflet Function
Description
Evaluate leaflet function by assessing the effective orifice area (EOA) (units: cm^2) via echocardiography
Time Frame
30 days
Title
Intended Performance of Optimum TAV - mean aortic valve gradient
Description
Evaluate hemodynamics by assessing the mean aortic valve gradient (units: mmHg) via echocardiography
Time Frame
30 days
Title
Intended Performance of Optimum TAV - peak aortic valve velocity
Description
Evaluate hemodynamics by assessing the peak aortic valve velocity (units: m/s) via echocardiography
Time Frame
30 days
Title
Intended Performance of Optimum TAV - Paravalvular Leak
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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; *
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;
Patient ineligible for or refuses blood transfusions;
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;*
Renal insufficiency as demonstrated by a serum creatinine > 3.0 mg/dL;
End stage renal disease requiring chronic dialysis;
Active infection requiring ongoing treatment;
Need for emergent surgery or intervention other than the investigational procedure;
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;
Currently participating in any other investigational drug or device study;
Patient lacking capacity to provide informed consent (history of any cognitive or mental health status that would interfere with study participation)
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mano Thubrikar, PhD
Phone
6106308284
Email
mano.thubrikar@tavi.us
Facility Information:
Facility Name
John Paul II Hospital, Dept. of Interventional Cardiology
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslaw Trebacz, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Safety and Performance Study of the Optimum Transcatheter Aortic Valve
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