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New treatment option for Mitral Regurgitation
Official title A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
ClinicalTrials.gov ID: NCT07086534
What this study is testing
- What it's testing
- To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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.
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Thousand Oaks, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thousand Oaks, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.