Aortic Valve StenosisNCT05909748
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
A study testing GEMINUS Transcatheter Aortic Valve Implantation system in people with Aortic Valve Stenosis, run by Valve Medical at 2 sites in Israel.
Trial summary
The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis. This is a prospective, open label, multicentre, single arm, first in human clinical study. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- GEMINUS Transcatheter Aortic Valve Implantation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- 21 May 2023to Apr 2030
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patient understands the implications of participating in the study and provides informed consent
- Patient is willing to comply with specified follow-up evaluation
- Severe aortic stenosis as per ACC/AHA 2020 guidelines (e.g. AVA ≤ 1.0 cm2 (or AVA index ≤ 0.6cm2/m2)* AND PV ≥ 4 m/sec or mean gradient ≥ 40 mmHg)** as determined by TTE/CT-TAVI
- May be larger with mixed AS/AR
- For low flow low gradient AS or paradoxical low flow severe AS must meet ACC/AHA guidelines (table 13 stages of AS in the guideline)
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- Cardiac Symptoms: ≥ NYHA Class II
- Patient ≥ intermediate surgical risk as assessed by the heart team or ≥75 years old.
- Aortic annulus diameter ≥22 mm and < 29 mm, assessed by CT TAVI
- Anatomically suitable for implantation of the GEMINUS device
- Peripheral vessels (common femoral and iliac arteries) of acceptable size (minimal diameter > 4mm), tortuosity, and calcification to accommodate the 12Fr catheter system.
- Patients assessed by the heart team to be at high risk for access site related bleeding/vascular complications due to the caliber/ calcification/ atherosclerosis of the iliofemoral vessels.
Who cannot join
- Patient not suitable for surgical bailout
- Congenital uni/bi/quadricuspid valve, or noncalcified aortic valve.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation ≥3+).
- Active or recent (within 6 months) endocarditis.
- Active systemic infections.
- Recent MI (≤ 1 month).
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- Any therapeutic invasive cardiac procedure (except BAV) performed within 30 days of the index procedure.
- Prosthetic heart valve in any position.
- Severe (> 3+) mitral, tricuspid or pulmonic regurgitation.
- Blood dyscrasias as defined: leukopenia (WBC<3000/mm3), acute anemia (Hb <8mg%), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Hemodynamic instability requiring inotropic support or mechanical support devices.
- Hypertrophic cardiomyopathy with or without obstruction (HCM).
- Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Active peptic ulcer or upper GI bleeding within the prior 3 months.
- Known hypersensitivity or contraindication to heparin, inability to tolerate antiplatelet therapy or sensitivity to contrast media (which cannot be adequately premedicated).
- Recent (<6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- Renal insufficiency (eGFR<30 mL/min) and/or end stage renal disease requiring chronic dialysis.
- Severe aortic disease, including abdominal aortic or thoracic aneurysm (lumen diameter > 5cm), marked tortuosity, or severe aortic arch atheroma.
- Life expectancy < 12 months due to non-cardiac co-morbid conditions.
- Currently participating in an investigational drug or another device study that has not reached its primary endpoint
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Ran Kornowski, Prof.
Ran Kornowski
- Not yet recruiting
Tel Aviv Sourasly Medical Center
Tel Aviv
Maayan Konigstein, Prof.
Maayan Konigstein, Prof
About this study
Official title: First in Human Study of the GEMINUS Transcatheter Aortic Valve Implantation System in Patients With Severe Symptomatic Aortic Stenosis
The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.
This is a prospective, open label, multicentre, single arm, first in human clinical study.
Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation
- Conditions
- Aortic Valve Stenosis
- Being tested
- GEMINUS Transcatheter Aortic Valve Implantation 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.
GEMINUS Transcatheter Aortic Valve Implantation systemDevice
Also called GEMINUS TAVI system
Implantation of the GEMINUS Transcatheter Aortic Valve Implantation system
| Study group | Role | What they receive |
|---|---|---|
| GEMINUS Transcatheter Aortic Valve Implantation system | Experimental | Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation Receives: Device: GEMINUS Transcatheter Aortic Valve Implantation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success (at exit from procedure room)
Technical success (at exit from procedure room) composite endpoint:
Freedom from mortality, Successful access, delivery of the device, and retrieval of the delivery System, Correct positioning of a single prosthetic heart valve into the proper anatomical location, Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Measured: immediately after procedure
Secondary outcomes (19)
Device success composite endpoint
Device success composite endpoint: Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication; Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)
Measured: 30 days
Early safety composite endpoint (VARC 3)
Early safety composite endpoint: Freedom from all-cause mortality; Freedom from all stroke; Freedom from ≥ VARC-3 type 2 bleeding; Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; Freedom from surgery or intervention related to the device
Measured: 30 days
Early safety composite endpoint (Modified VARC)
Early safety composite endpoint: Freedom from all-cause mortality; Freedom from all stroke; Freedom from ≥ Modified VARC type 3 bleeding; Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; Freedom from surgery or intervention related to the device
Measured: 30 days
Clinical efficacy composite endpoint
Clinical efficacy composite endpoint: Freedom from all-cause mortality; Freedom from all stroke; Freedom from hospitalization for procedure- or valve-related causes; Freedom from KCCQ Overall Summary Score <45 or decline from baseline of >10 point (i.e. Unfavourable Outcome)
Measured: 1, 2, 3, 4, 5 years
All-cause mortality
All-cause mortality
Measured: 30 days, 6 months, 1, 2, 3, 4, 5 years
Disabling stroke
Disabling stroke
Measured: 6 months, 2, 3, 4, 5 years
Any stroke
Any stroke
Measured: 30 days, 6 months, 1, 2, 3, 4, 5 years
Peri-procedural MI (per ARC-2)
Peri-procedural MI (per ARC-2).
Measured: within 2 days after procedure
Repeat hospitalization for procedure or valve related cause
Repeat hospitalization for procedure or valve related cause
Measured: 30 days, 6 months, 1, 2, 3, 4, 5 years
Repeat aortic valve intervention
Repeat aortic valve intervention
Measured: 30 days, 6 months, 1, 2, 3, 4, 5 years
AKI (Stage 3 or 4)
AKI (Stage 3 or 4)
Measured: 30 days
Bleeding ≥ VARC-3 type 2
Bleeding ≥ VARC-3 type 2
Measured: 30 days, 6 months, 1, 2, 3, 4, 5 years
Bleeding ≥ Modified VARC type 3
Bleeding ≥ Modified VARC type 3
Measured: 30 days, 6 months, 1, 2, 3, 4, 5 years
KCCQ- Kansas City Cardiomyopathy Questionnaire
Kansas City Cardiomyopathy Questionnaire, 0-5 (none- extremily)
Measured: 6 months, 1 year
Hemodynamic valve performance: Mean pressure gradient
Hemodynamic valve performance: Mean pressure gradient
Measured: pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Hemodynamic valve performance: peak velocity
Hemodynamic valve performance: peak velocity
Measured: pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Hemodynamic valve performance: aortic valve area
Hemodynamic valve performance: aortic valve area
Measured: pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Hemodynamic valve performance: aortic regurgitation
Hemodynamic valve performance: aortic regurgitation
Measured: pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
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 posted18 Jun 2023
- Study start21 May 2023
- Primary completionDec 2027 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valve Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ran Kornowski, Prof., Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909748
- Sponsor's protocol ID
- GEMINUS-001
- Status last verified
- Aug 2026
- First submitted
- 30 May 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Study of the GEMINUS Transcatheter Aortic Valve Implantation System in Patients With Severe Symptomatic Aortic Stenosis
- ClinicalTrials.gov ID
- NCT05909748
- Acronym / sponsor ID
- GEMINUS-001
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Valve MedicalIndustry (pharma, biotech, devices)
- Study start
- 21 May 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 18 Jun 2023 (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 main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.
This is a prospective, open label, multicentre, single arm, first in human clinical study.
Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GEMINUS Transcatheter Aortic Valve Implantation system | Experimental | Device: GEMINUS Transcatheter Aortic Valve Implantation systemClinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Patient understands the implications of participating in the study and provides informed consent
- Patient is willing to comply with specified follow-up evaluation
- Severe aortic stenosis as per ACC/AHA 2020 guidelines (e.g. AVA ≤ 1.0 cm2 (or AVA index ≤ 0.6cm2/m2)* AND PV ≥ 4 m/sec or mean gradient ≥ 40 mmHg)** as determined by TTE/CT-TAVI
- May be larger with mixed AS/AR
Key exclusion criteria (22 listed)
- Patient not suitable for surgical bailout
- Congenital uni/bi/quadricuspid valve, or noncalcified aortic valve.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation ≥3+).
- Active or recent (within 6 months) endocarditis.
- Active systemic infections.
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 |
|---|---|---|
| GEMINUS Transcatheter Aortic Valve Implantation systemAlso: GEMINUS TAVI systemImplantation of the GEMINUS Transcatheter Aortic Valve Implantation system | Device | GEMINUS Transcatheter Aortic Valve Implantation system |
Primary outcome
Technical success (at exit from procedure room)
Time frame: immediately after procedure
Technical success (at exit from procedure room) composite endpoint: Freedom from mortality, Successful access, delivery of the device, and retrieval of the delivery System, Correct positioning of a single prosthetic heart valve into the proper anatomical location, Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
19 secondary outcomes
Device success composite endpoint
Time frame: 30 days
Early safety composite endpoint (VARC 3)
Time frame: 30 days
Early safety composite endpoint (Modified VARC)
Time frame: 30 days
Clinical efficacy composite endpoint
Time frame: 1, 2, 3, 4, 5 years
All-cause mortality
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Disabling stroke
Time frame: 6 months, 2, 3, 4, 5 years
Any stroke
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Peri-procedural MI (per ARC-2)
Time frame: within 2 days after procedure
Repeat hospitalization for procedure or valve related cause
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Repeat aortic valve intervention
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
AKI (Stage 3 or 4)
Time frame: 30 days
Bleeding ≥ VARC-3 type 2
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Bleeding ≥ Modified VARC type 3
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
KCCQ- Kansas City Cardiomyopathy Questionnaire
Time frame: 6 months, 1 year
Hemodynamic valve performance: Mean pressure gradient
Time frame: pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Hemodynamic valve performance: peak velocity
Time frame: pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Hemodynamic valve performance: aortic valve area
Time frame: pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Hemodynamic valve performance: aortic regurgitation
Time frame: pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years
Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
Time frame: 30 days
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 Aug 2026.
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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.
Ran Kornowski, Prof. principal investigator
Rabin Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GEMINUS Transcatheter Aortic Valve Implantation system in people with Aortic Valve Stenosis, run by Valve Medical at 2 sites in Israel.
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 12 inclusion and 22 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 Brenda Koltun Reuven (972-542666688, brendak@medinol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (at exit from procedure room) (time frame: immediately after procedure). 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 Aug 2026.