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Safety and Performance Study of the Optimum Transcatheter Aortic Valve

ConditionSevere Aortic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorThubrikar Aortic Valve, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Patients Receiving Optimum TAVExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Device Success

Valve deployed from delivery system successfully

Time frame
30 days
2

Correct Positioning

Deploying a single Optimum TAV in the intended anatomical position and confirming via fluoroscopy as determined by the implanting physician

Time frame
30 days
3

Intended Performance of Optimum TAV - Leaflet Function

Evaluate leaflet function by assessing the effective orifice area (EOA) (units: cm\^2) via echocardiography

Time frame
30 days
4

Intended Performance of Optimum TAV - mean aortic valve gradient

Evaluate hemodynamics by assessing the mean aortic valve gradient (units: mmHg) via echocardiography

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thubrikar Aortic Valve, Inc.

Lead sponsor

KCRI

Collaborator

Source ClinicalTrials.gov
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