Severe Aortic StenosisNCT04076150
Safety and Performance Study of the Optimum Transcatheter Aortic Valve
A study testing Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System in people with Severe Aortic Stenosis, run by Thubrikar Aortic Valve, Inc. at 1 site in Poland.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 sitePoland
- Study dates
- 18 May 2022to 18 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
- 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 operative mortality risk to > 15%.
- Geographically available and willing to comply with follow up.
Who cannot join
- 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*
Show all 26Show fewer
- 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 evidenced by peripheral MSCT;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
John Paul II Hospital, Dept. of Interventional Cardiology
Krakow, 31-202
Jaroslaw Trebacz, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Severe Aortic Stenosis
- Being tested
- Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV SystemDevice
Also called Transcatheter Aortic Valve Replacement
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving Optimum TAV | Experimental | Patients with symptomatic severe aortic stenosis that will be treated via transcatheter aortic valve implantation procedure Receives: Device: Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success
Valve deployed from delivery system successfully
Measured: 30 days
Correct Positioning
Deploying a single Optimum TAV in the intended anatomical position and confirming via fluoroscopy as determined by the implanting physician
Measured: 30 days
Intended Performance of Optimum TAV - Leaflet Function
Evaluate leaflet function by assessing the effective orifice area (EOA) (units: cm^2) via echocardiography
Measured: 30 days
Intended Performance of Optimum TAV - mean aortic valve gradient
Evaluate hemodynamics by assessing the mean aortic valve gradient (units: mmHg) via echocardiography
Measured: 30 days
Intended Performance of Optimum TAV - peak aortic valve velocity
Evaluate hemodynamics by assessing the peak aortic valve velocity (units: m/s) via echocardiography
Measured: 30 days
Intended Performance of Optimum TAV - Paravalvular Leak
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start18 May 2022
- Primary completion18 Dec 2022 (estimated)
- Study completion18 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thubrikar Aortic Valve, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076150
- Sponsor's protocol ID
- THUB-CLIN-2018-01
- Status last verified
- Sep 2022
- First submitted
- 9 Aug 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant
- ClinicalTrials.gov ID
- NCT04076150
- Acronym / sponsor ID
- THUB-CLIN-2018-01
- Conditions
- Severe Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Thubrikar Aortic Valve, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Study start
- 18 May 2022 (actual)
- Primary completion
- 18 Dec 2022 (estimated)
- Study completion
- 18 May 2027 (estimated)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Optimum TAV | Experimental | Device: Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV SystemPatients with symptomatic severe aortic stenosis that will be treated via transcatheter aortic valve implantation procedure |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
- Aortic valve annular diameter ≥ 21 and ≤ 23mm measured by MSCT (Multi-Slice Computed Tomography).
Key exclusion criteria (26 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV SystemAlso: Transcatheter Aortic Valve ReplacementTreating 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. | Device | Patients Receiving Optimum TAV |
Primary outcome
Device Success
Time frame: 30 days
Valve deployed from delivery system successfully
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
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
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System in people with Severe Aortic Stenosis, run by Thubrikar Aortic Valve, Inc. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mano Thubrikar, PhD (6106308284, mano.thubrikar@tavi.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Success (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.