Safety and Performance Study of the Optimum Transcatheter Aortic Valve

NCT04076150 | Recruiting

• 1 other identifier: THUB-CLIN-2018-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Aortic Stenosis

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Patients Receiving Optimum TAV

EXPERIMENTAL

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

Interventions

Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System DEVICE

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.

Also known as: Transcatheter Aortic Valve Replacement

Patients Receiving Optimum TAV

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Willing and capable to provide informed consent;
• 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.

You may not qualify if:

• 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; \*

Sponsors & Collaborators

• Thubrikar Aortic Valve, Inc.: lead
• KCRI: collaborator

Study Sites (1)

John Paul II Hospital, Dept. of Interventional Cardiology

Krakow, 31-202, Poland

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Mano Thubrikar, PhD

CONTACT

6106308284; mano.thubrikar@tavi.us

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: September 3, 2019
• Study Start: May 18, 2022
• Primary Completion: December 18, 2022
• Study Completion (Estimated): May 18, 2027
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

PL (1)