Aortic Stenosis SymptomaticNCT06680427
Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
A study testing Siegel Transcatheter Aortic Valve (TAVR) in people with Aortic Stenosis Symptomatic, run by MiRus at 8 sites in United States.
Trial summary
The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Stenosis Symptomatic
- What is being tested?
- Siegel Transcatheter Aortic Valve (TAVR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- 26 Mar 2025to Dec 2025
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible for entry in this study if all the following conditions are met:
- Symptomatic, severe native aortic stenosis in subjects 50 years or older Aortic Valve Area (AVA) ≤ 1.0 cm2 or Aortic Valve Area (AVA) index ≤ 0.6 cm2/m2 and Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or dimensionless Index <0.25
- New York Heart Association Functional Class ≥ 2
- Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
- Eligible for transfemoral delivery of the Siegel TAVR
- Native aortic annulus suitable for safe placement of Siegel 23mm or 26mm transcatheter heart valve (preprocedural measurements by Transthoracic Echocardiogram (TTE) and Computed Tomography (CT) of area derived aortic annulus diameter)
- Understands the study requirements and the treatment procedures and provides written informed consent
- Subject agrees to complete all required scheduled follow-up visits.
Who cannot join
- Subjects will be excluded for entry in this study if any of the following conditions are met:
- Anatomical
- Anatomy precluding safe placement of Siegel TAVR
- Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Pre-existing prosthetic heart valve in any position (note, mitral ring is not an exclusion).
- Unicuspid or bicuspid aortic valve
Show all 39Show fewer
- Severe aortic regurgitation (>3+)
- Severe mitral or severe tricuspid regurgitation(>3+) requiring intervention.
- Moderate to severe mitral stenosis.
- Hypertrophic obstructive cardiomyopathy
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
- Severe basal septal hypertrophy with outflow gradient Clinical
- Evidence of an acute myocardial infarction ≤ 30 days before enrollment.
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
- Blood dyscrasias as defined: leukopenia (WBC < 3000 cell/mL, anemia (Hgb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mL), history of bleeding diathesis or coagulopathy.
- Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support within the past 30 days.
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of enrollment
- Need for emergency surgery for any reason
- Ventricular dysfunction with left ventricular ejection fraction (LVEF) < 30% as measured by resting echocardiogram
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
- Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy, or end stage renal disease requiring chronic dialysis
- GI bleeding within the past 3 months
- Severe lung disease with Forced Expiratory Volume in 1 second (FEV1) < 50% predicted or currently on home oxygen
- History of cirrhosis or any active liver disease
- Significant frailty as determined by the Heart Team (after objective assessment of frailty parameters).
- Significant abdominal or thoracic aortic disease (such as porcelain aorta, abdominal aortic aneurysm > 5.0 cm, severe calcification, aortic coarctation, etc.) that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR .
- Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 2/3 systemic pressure)
- A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, molybdenum, rhenium, ticlopidine and clopidogrel, contrast media
- Ongoing sepsis, including active endocarditis
- Body Mass Index (BMI) > 50 kg/m2
- Subject refuses a blood transfusion
- Life expectancy < 24 months due to associated non-cardiac co-morbid conditions
- Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent
- Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
- Currently participating in an investigational drug or another investigational device trial
- Subject is contraindicated for cardiac computed tomography (CT).
- Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Piedmont Healthcare
Atlanta, Georgia, 30309
Cleveland Clinic
Cleveland, Ohio, 44195
Cedars-Sinai Medical Center
Los Angeles, California, 90071
Atlantic Health System
Morristown, New Jersey, 07960
NCH Healthcare System
Naples, Florida, 34102
Columbia University Medical Center/ NYPH
New York, New York, 10032
Stanford
Palo Alto, California, 94304
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.
Read the detailed description
The Siegel™ Transcatheter Aortic Valve (TAVR) Early Feasibility Study is a prospective, non-randomized, single-arm, multi-center study conducted in the US. The primary objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.
- Conditions
- Aortic Stenosis Symptomatic
- Being tested
- Siegel Transcatheter Aortic Valve (TAVR)
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Stenosis
- 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.
Siegel Transcatheter Aortic Valve (TAVR)Device
Replacement of native aortic valve with the Siegel Transcatheter Aortic Valve (TAVR) by a transfemoral approach.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Device: Siegel Transcatheter Aortic Valve (TAVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of implantation of the Siegel TAVR
Technical success will be reported as freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device.
Measured: Immediate post procedure
All-cause mortality or disabling stroke
Mortality will be reported as rate of death/mortality at 30 days. Disabling stroke will be reported according to Valve Academic Research Consortium (VARC-3) Guidelines
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 posted8 Nov 2024
- Study start26 Mar 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis SymptomaticStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiRus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680427
- Sponsor's protocol ID
- MR-001
- Status last verified
- Sep 2025
- First submitted
- 5 Nov 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
- ClinicalTrials.gov ID
- NCT06680427
- Acronym / sponsor ID
- MR-001
- Conditions
- Aortic Stenosis Symptomatic
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MiRusIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Nov 2024 (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 Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.
Detailed description
The Siegel™ Transcatheter Aortic Valve (TAVR) Early Feasibility Study is a prospective, non-randomized, single-arm, multi-center study conducted in the US. The primary objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Siegel Transcatheter Aortic Valve (TAVR) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Symptomatic, severe native aortic stenosis in subjects 50 years or older Aortic Valve Area (AVA) ≤ 1.0 cm2 or Aortic Valve Area (AVA) index ≤ 0.6 cm2/m2 and Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or dimensionless Index <0.25
- New York Heart Association Functional Class ≥ 2
- Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
- Eligible for transfemoral delivery of the Siegel TAVR
- Native aortic annulus suitable for safe placement of Siegel 23mm or 26mm transcatheter heart valve (preprocedural measurements by Transthoracic Echocardiogram (TTE) and Computed Tomography (CT) of area derived aortic annulus diameter)
Key exclusion criteria (39 listed)
- Subjects will be excluded for entry in this study if any of the following conditions are met:
- Anatomical
- Anatomy precluding safe placement of Siegel TAVR
- Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Pre-existing prosthetic heart valve in any position (note, mitral ring is not an exclusion).
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 |
|---|---|---|
| Siegel Transcatheter Aortic Valve (TAVR)Replacement of native aortic valve with the Siegel Transcatheter Aortic Valve (TAVR) by a transfemoral approach. | Device | Treatment Arm |
Primary outcome
Technical success of implantation of the Siegel TAVR
Time frame: Immediate post procedure
Technical success will be reported as freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device.
All-cause mortality or disabling stroke
Time frame: 30 Days
Mortality will be reported as rate of death/mortality at 30 days. Disabling stroke will be reported according to Valve Academic Research Consortium (VARC-3) Guidelines
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 3 Dec 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Siegel Transcatheter Aortic Valve (TAVR) in people with Aortic Stenosis Symptomatic, run by MiRus at 8 sites in United States.
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 8 inclusion and 39 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of implantation of the Siegel TAVR (time frame: Immediate post procedure). The study lists 2 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 3 Dec 2025.