Safety and Performance Study of the Optimum Transcatheter Aortic Valve

September 14, 2022 updated by: Thubrikar Aortic Valve, Inc.

A First-in-Human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of the study is to assess the safety and performance of the Optimum TAV (Transcatheter Aortic Valve) in patients with symptomatic, severe aortic stenosis who are deemed high-risk for SAVR (Surgical Aortic Valve Replacement) or have contraindications or deemed inoperable for SAVR.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Kraków, Poland, 31-202
        • Recruiting
        • John Paul II Hospital, Dept. of Interventional Cardiology
        • Contact:
          • Jaroslaw Trebacz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients Receiving Optimum TAV
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
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.
Other Names:
  • Transcatheter Aortic Valve Replacement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Device Success
Time Frame: 30 days
Valve deployed from delivery system successfully
30 days
Correct Positioning
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
Evaluate hemodynamics by assessing the mean aortic valve gradient (units: mmHg) via echocardiography
30 days
Intended Performance of Optimum TAV - peak aortic valve velocity
Time Frame: 30 days
Evaluate hemodynamics by assessing the peak aortic valve velocity (units: m/s) via echocardiography
30 days
Intended Performance of Optimum TAV - Paravalvular Leak
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thubrikar Aortic Valve, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KCRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THUB-CLIN-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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