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Tests treatment safety and results for Severe Aortic Stenosis
Official title Safety and Performance Study of the Optimum Transcatheter Aortic Valve
ClinicalTrials.gov ID: NCT04076150
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- 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...
- 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).
You likely can't join 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\
See the full eligibility 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...
- 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...
- Geographically available and willing to comply with follow up.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Krakow, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Krakow, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.