Safety and Performance Study of the Optimum Transcatheter Aortic Valve

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

Study Overview

• Status: Recruiting
• Conditions: Severe Aortic Stenosis
• Intervention / Treatment: Device: Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mano Thubrikar, PhD; Phone Number: 6106308284; Email: mano.thubrikar@tavi.us

Study Locations

• Poland
  • Kraków, Poland, 31-202
    • Recruiting
    • John Paul II Hospital, Dept. of Interventional Cardiology
    • Contact: Jaroslaw Trebacz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willing and capable to provide informed consent;
2. 70 years of age or older;
3. 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.
4. Symptomatology due to native aortic stenosis resulting in a New York Heart Association (NYHA) functional classification of II or greater.
5. Aortic valve annular diameter ≥ 21 and ≤ 23mm measured by MSCT (Multi-Slice Computed Tomography).
6. 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%.
7. Geographically available and willing to comply with follow up.

Exclusion Criteria:

1. Congenital unicuspid or bicuspid aortic valve;
2. Noncalcified aortic valve;
3. Valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success;
4. Severe (Grade 3 to 4) aortic, mitral, or tricuspid valve regurgitation;
5. Moderate to severe mitral stenosis;
6. Myocardial infarction within the past 30 days*
7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
8. LVEF (Left Ventricular Ejection Fraction) < 30%;
9. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure;
10. Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months; *
11. Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery;
12. Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy;
13. Patient ineligible for or refuses blood transfusions;
14. 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;
15. Gastrointestinal bleeding within the past 30 days; *
16. Stroke or transient ischemic attack (TIA) within past 3 months;*
17. Renal insufficiency as demonstrated by a serum creatinine > 3.0 mg/dL;
18. End stage renal disease requiring chronic dialysis;
19. Active infection requiring ongoing treatment;
20. Need for emergent surgery or intervention other than the investigational procedure;
21. Hypersensitivity or contraindication to procedural medication(s) and device material(s) (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated;
22. Life expectancy < 1 year due to non-cardiac co-morbid conditions;
23. Currently participating in any other investigational drug or device study;
24. Patient lacking capacity to provide informed consent (history of any cognitive or mental health status that would interfere with study participation)

25. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients Receiving Optimum TAV; Patients with symptomatic severe aortic stenosis that will be treated via transcatheter aortic valve implantation procedure

Device: Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System; 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.; Other Names: Transcatheter Aortic Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Valve deployed from delivery system successfully	30 days
Correct Positioning	Deploying a single Optimum TAV in the intended anatomical position and confirming via fluoroscopy as determined by the implanting physician	30 days
Intended Performance of Optimum TAV - Leaflet Function	Evaluate leaflet function by assessing the effective orifice area (EOA) (units: cm^2) via echocardiography	30 days
Intended Performance of Optimum TAV - mean aortic valve gradient	Evaluate hemodynamics by assessing the mean aortic valve gradient (units: mmHg) via echocardiography	30 days
Intended Performance of Optimum TAV - peak aortic valve velocity	Evaluate hemodynamics by assessing the peak aortic valve velocity (units: m/s) via echocardiography	30 days
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.	30 days

Collaborators and Investigators

• Sponsor: Thubrikar Aortic Valve, Inc.
• Collaborators: KCRI

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Anticipated): December 18, 2022
• Study Completion (Anticipated): May 18, 2027

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: THUB-CLIN-2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No