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
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
Treatments tested in this trial
- Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Thubrikar Aortic Valve, Inc.
Lead sponsor
KCRI
Collaborator
Source ClinicalTrials.gov