Assessing the safety and performance of a new transcatheter aortic valve

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and performance of the Optimum Transcatheter Aortic Valve (TAV) in patients suffering from symptomatic severe aortic stenosis. It targets individuals who are at high risk for traditional surgical aortic valve replacement (SAVR) or are considered inoperable. The study involves implanting the Optimum TAV system and monitoring its feasibility and safety outcomes in a first-in-human approach. Participants will be closely followed to assess their health and valve performance post-implantation.

Why it matters

Who can join: the full rules

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.

Where it's running

• John Paul II Hospital, Dept. of Interventional Cardiology
  Krakow, Poland Recruiting

Study contacts

• Study coordinator: Mano Thubrikar, PhD
• Email: mano.thubrikar@tavi.us
• Phone: 6106308284

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry of Transcatheter Aortic Valve Treatments at a Italian Center

  This registry tests how safe and effective transcatheter valve procedures are in adults with severe aortic stenosis treated at a single Italian center.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Pavia · NCT07596394

• CT-FFR-guided revascularization for people with severe aortic stenosis

  This study will see if adding CT-FFR (a noninvasive blood-flow test) to preoperative CT angiography helps doctors decide whether people with severe aortic stenosis need coronary revascularization before valve replacement.

  Recruiting Yan'an Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07469371

• RENATUS transcatheter aortic valve for severe aortic stenosis

  This trial tests the RENATUS transcatheter aortic valve in people with symptomatic severe aortic stenosis who are eligible for TAVR.

  Recruiting at 4 sites Beijing Balance Medical Technology Co., Ltd · Beijing and 3 other locations · NCT07414342

• Pre-emptive LAVA-ECMO support for complex, high-risk TAVR

  The team will try pre-emptive left atrial veno-arterial ECMO to stabilize adults with severe aortic stenosis undergoing complex, high-risk TAVR who are unstable or at risk of instability.

  Recruiting at 2 sites Atlantic Health System · Detroit, Michigan and 1 other locations · NCT07309029

• Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis

  This trial will test whether the DurAVR transcatheter heart valve works as well and is as safe as SAPIEN or Evolut valves in people with severe calcific aortic stenosis, and it also includes a registry for people needing valve‑in‑valve procedures.

  Recruiting Anteris Technologies Ltd. · Copenhagen, Capital Region of Denmark · NCT07194265

• Navitor TAVI valve in Japanese patients with severe aortic stenosis

  This study will try the Navitor transcatheter aortic valve with the FlexNav delivery system in about 100 Japanese adults with symptomatic severe aortic stenosis to track safety and how well the valve works.

  Recruiting at 3 sites Abbott Medical Devices · Fukuoka and 2 other locations · NCT07193888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.