Mitral RegurgitationNCT07086534
A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
A study testing GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System in people with Mitral Regurgitation, run by Sierra Valve LLC at 1 site in United States.
Trial summary
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to 31 May 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older(≥ 18 years)
- Subject has severe MR (Grade lll or greater per the ASE criteria, which includes severity grades of 3+ and 4+). Severity grades (3+)/ (4+) MR confirmed by core lab review on transthoracic or transesophageal echocardiography.
- For patients with primary mitral regurgitation: Deemed high or prohibitive surgical risk (STS score 8 for valve replacement or > 6 for valve repair or determined by the site heart team due to documented surgical risk factors) For patients with secondary mitral regurgitation: undergone optimal guideline-directed medical therapy (GDMT) for at least one month as determined by the local heart team; coronary revascularization, and cardiac resynchronization therapy (CRT) if clinically indicated, all of which have proven to be ineffective. Local heart team has determined that mitral valve surgery is not an option.
- Anatomically suitable for TEER with GeminiOne device as confirmed by site investigators, core lab, and eligibility committee.
- Feasible transseptal catheterization and femoral vein access.
- Written informed consent from subject or legal representative.
Who cannot join
- History of heart transplantation, prior mitral valve replacement surgery, or transcatheter mitral valve procedure.
- Leaflet anatomy that precludes optimal positioning of the GeminiOne device, as determined by site investigators, core lab, and eligibility committee.
- Evidence of severe calcification or significant cleft in the grasping area of the mitral valve leaflets.
- Left ventricular ejection fraction (LVEF)< 20%
- Left ventricular end-systolic diameter(LVESD)> 60mm
- Mobile leaflet length less than 10mm
Show all 21Show fewer
- Mitral valve effective orifice area (EOA) < 3.5cm or a high risk of mitral stenosis developing after device implantation, as judged by site investigators, core lab, and eligibility committee.
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Presence of severe non-mitral valve disease requiring intervention.
- Severe pulmonary artery hypertension(sPAP >70mmHg).
- Severe right ventricular dysfunction. 12, Active endocarditis or history of mitral valve endocarditis. Active rheumatic heart disease or leaflets severely degenerated from rheumatic disease.
- 13. Severe untreated coronary artery stenosis requiring revascularization or other cardiovascular disease requiring surgery.
- 14.Patents with extreme frailty. 15.Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure besides dilated cardiomyopathy.
- 16. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) < 25 mL/min.
- 17. Blood cachexia including granulocytopenia(WBC<3x10^9/L),acute anemia(HB <90g/L)thrombocytopenia (PLT <50x10^9/L), severe coagulopathy, or contraindications to anticoagulant and antiplatelet therapy.
- 18. Evidence of an acute myocardial infarction within the past 4 weeks. 19.Evidence of stroke within the prior 90 days. 20. Any percutaneous cardiac intervention, carotid surgery, or any cardiac surgery within 30 days prior to procedure.
- 21. Severe symptomatic carotid artery stenosis exceeding 70% confirmed by imaging.
- 22. Subjects with underlying medical or psychiatric conditions that may interfere with trial evaluation (e.g. cancer, infection, severe metabolic disease). Additionally, any case deemed unsuitable for the study by the local heart team.
- 23.Life expectancy of less than 12 months. 24. Participation in another investigational drug or device study within the past 1 month.
- 25. Subjects deemed unlikely to complete the trial due to potential non-compliance, as judged by the investigator.
- 26. Any anatomic characteristic or presence of atrial septal occluders, which would preclude the performance of the transseptal approach.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Los Robles Regional Medical Centre
Thousand Oaks, California, 91360
Saibal Kar, Saibal.Kar@hcahealthcare.com
About this study
Official title: A Clinical Study of GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for the Treatment of Severe, Symptomatic Mitral Regurgitation (MR).
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
Read the detailed description
This study is a prospective, multi-center, non-randomized clinical trial. All enrolled subjects will receive the investigational GeminiOne TEER System in a single-arm design. The trial will be conducted at up to seven clinical centers located in the United States, Canada, and Europe.
The GeminiOne TEER System is intended for use in adult patients with severe symptomatic mitral regurgitation (MR) who have suitable anatomy for both device implantation and transfemoral trans-septal access for left atrial delivery.
Key Inclusion Criteria:
Primary MR: Patients must be deemed high-risk for surgical intervention by the site's heart team.
Secondary MR: Patients must have failed to respond to optimal guideline-directed medical therapy (GDMT) for at least one month, and must also have received appropriate coronary revascularization and cardiac resynchronization therapy (CRT), if indicated.
Initially, up to 15 subjects will be treated. The total duration of the study is expected to be approximately 72 months. The enrollment period will span approximately 12 months. Subjects who receive the investigational device will be followed for 60 months post-implantation.
- Conditions
- Mitral Regurgitation
- Being tested
- GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeminiOne Transcatheter Edge-to-Edge Repair (TEER) SystemDevice
The GeminiOne TEER System consists of a TEER clip implant, transcatheter delivery system and a guide sheath.
The clip is made of cobalt-chromium-nickel alloy with a nickel-titanium alloy gripper, covered with a braided mesh of polyethylene terephthalate (PET) materials.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving the treatment of GeminiOne TEER system | Experimental | Not described Receives: Device: GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Absence of device or procedure related major adverse events at 30 days
MAE is defined as the occurrence of any of the following within 30 days: death, myocardial infarction (Ml) stroke, MVARC-defined Grade 3 Acute Kidney Injury (AKl), major access site and vascular complications, major cardiac structural complications or cardiac surgery due to GeminiOne device failure.
Measured: 30 days
Effectiveness: Acute procedural success (APS)
APS is defined as the successful implantation of the GeminiOne device and achieving residual MR of 2+ or less at discharge. lf the discharge echocardiogram is unavailable or difficult to interpret, an echocardiogram taken at 30 days can be used instead. A death before discharge or a reoperation of the mitral valve within 30 days is considered an acute procedural failure.
Measured: 30 days
Secondary outcomes (9)
All-cause mortality and stroke
Measured: 30 days, 12 months and annually thereafter
Cardiovascular mortality
Measured: 30 days, 12 months and annually thereafter
Rate of cardiovascular rehospitalization
Measured: 30 days, 12 months and annually thereafter
Mitral valve surgery or re-intervention
Measured: 30 days, 12 months and annually thereafter
Change in NYHA functional class
Measured: 30 days, 12 months and annually thereafter
Mitral valve hemodynamics
Includes degree of residual mitral regurgitation and mean mitral valve gradient.
Measured: 30 days, 12 months and annually thereafter
Change in 6-Minute Walk Test (6MWT) performance
Measured: 30 days, 12 months and annually thereafter
Change in Quality of Life as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: 30 days, 12 months and annually thereafter
Incidence of serious adverse events (SAEs)
A SAE is defined as any adverse event that meets one or more of the following criteria:<
- Death
- life-threatening or results in serious illness or injury
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Results in a congenital anomaly/birth defect, fetal death, or fetal distress
- Requires medical or surgical intervention to prevent permanent impairment to a body structure or body function
- considered an important medical event that may jeopardize the patient or subject and/or may require intervention to prevent one of the outcomes listed above, based on appropriate medical judgment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start26 Mar 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sierra Valve LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086534
- Sponsor's protocol ID
- EFSGemini1US
- Status last verified
- Apr 2026
- First submitted
- 15 Jul 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for the Treatment of Severe, Symptomatic Mitral Regurgitation (MR).
- ClinicalTrials.gov ID
- NCT07086534
- Acronym / sponsor ID
- EFSGemini1US
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sierra Valve LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 25 Jul 2025 (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.
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
Detailed description
This study is a prospective, multi-center, non-randomized clinical trial. All enrolled subjects will receive the investigational GeminiOne TEER System in a single-arm design. The trial will be conducted at up to seven clinical centers located in the United States, Canada, and Europe.
The GeminiOne TEER System is intended for use in adult patients with severe symptomatic mitral regurgitation (MR) who have suitable anatomy for both device implantation and transfemoral trans-septal access for left atrial delivery.
Key Inclusion Criteria:
Primary MR: Patients must be deemed high-risk for surgical intervention by the site's heart team.
Secondary MR: Patients must have failed to respond to optimal guideline-directed medical therapy (GDMT) for at least one month, and must also have received appropriate coronary revascularization and cardiac resynchronization therapy (CRT), if indicated.
Initially, up to 15 subjects will be treated. The total duration of the study is expected to be approximately 72 months. The enrollment period will span approximately 12 months. Subjects who receive the investigational device will be followed for 60 months 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 |
|---|---|---|
| Subjects receiving the treatment of GeminiOne TEER system | Experimental | Device: GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older(≥ 18 years)
- Subject has severe MR (Grade lll or greater per the ASE criteria, which includes severity grades of 3+ and 4+). Severity grades (3+)/ (4+) MR confirmed by core lab review on transthoracic or transesophageal echocardiography.
- For patients with primary mitral regurgitation: Deemed high or prohibitive surgical risk (STS score 8 for valve replacement or > 6 for valve repair or determined by the site heart team due to documented surgical risk factors) For patients with secondary mitral regurgitation: undergone optimal guideline-directed medical therapy (GDMT) for at least one month as determined by the local heart team; coronary revascularization, and cardiac resynchronization therapy (CRT) if clinically indicated, all of which have proven to be ineffective. Local heart team has determined that mitral valve surgery is not an option.
- Anatomically suitable for TEER with GeminiOne device as confirmed by site investigators, core lab, and eligibility committee.
- Feasible transseptal catheterization and femoral vein access.
Key exclusion criteria (21 listed)
- History of heart transplantation, prior mitral valve replacement surgery, or transcatheter mitral valve procedure.
- Leaflet anatomy that precludes optimal positioning of the GeminiOne device, as determined by site investigators, core lab, and eligibility committee.
- Evidence of severe calcification or significant cleft in the grasping area of the mitral valve leaflets.
- Left ventricular ejection fraction (LVEF)< 20%
- Left ventricular end-systolic diameter(LVESD)> 60mm
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 |
|---|---|---|
| GeminiOne Transcatheter Edge-to-Edge Repair (TEER) SystemThe GeminiOne TEER System consists of a TEER clip implant, transcatheter delivery system and a guide sheath. The clip is made of cobalt-chromium-nickel alloy with a nickel-titanium alloy gripper, covered with a braided mesh of polyethylene terephthalate (PET) materials. | Device | Subjects receiving the treatment of GeminiOne TEER system |
Primary outcome
Safety: Absence of device or procedure related major adverse events at 30 days
Time frame: 30 days
MAE is defined as the occurrence of any of the following within 30 days: death, myocardial infarction (Ml) stroke, MVARC-defined Grade 3 Acute Kidney Injury (AKl), major access site and vascular complications, major cardiac structural complications or cardiac surgery due to GeminiOne device failure.
Effectiveness: Acute procedural success (APS)
Time frame: 30 days
APS is defined as the successful implantation of the GeminiOne device and achieving residual MR of 2+ or less at discharge. lf the discharge echocardiogram is unavailable or difficult to interpret, an echocardiogram taken at 30 days can be used instead. A death before discharge or a reoperation of the mitral valve within 30 days is considered an acute procedural failure.
9 secondary outcomes
All-cause mortality and stroke
Time frame: 30 days, 12 months and annually thereafter
Cardiovascular mortality
Time frame: 30 days, 12 months and annually thereafter
Rate of cardiovascular rehospitalization
Time frame: 30 days, 12 months and annually thereafter
Mitral valve surgery or re-intervention
Time frame: 30 days, 12 months and annually thereafter
Change in NYHA functional class
Time frame: 30 days, 12 months and annually thereafter
Mitral valve hemodynamics
Time frame: 30 days, 12 months and annually thereafter
Change in 6-Minute Walk Test (6MWT) performance
Time frame: 30 days, 12 months and annually thereafter
Change in Quality of Life as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 30 days, 12 months and annually thereafter
Incidence of serious adverse events (SAEs)
Time frame: 12 months
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 24 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System in people with Mitral Regurgitation, run by Sierra Valve LLC at 1 site 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 6 inclusion and 21 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 24 Apr 2026. 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 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?
Contact Jianfong Tan (+19495397412, Jianfong@Sierravalve.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Absence of device or procedure related major adverse events at 30 days (time frame: 30 days). 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 24 Apr 2026.