Thousand Oaks, CANCT07086534Now EnrollingIRB Ready

Mitral Regurgitation Clinical Trial in Thousand Oaks, CA

Access cutting-edge mitral regurgitation treatment through this clinical trial at a research site in Thousand Oaks. Study-provided care at no cost to qualified participants.

Sponsored by Sierra Valve LLC

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Expert Care in Thousand Oaks

Access mitral regurgitation specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related mitral regurgitation treatment provided free

Apply for This Thousand Oaks Location

Check if you qualify for this mitral regurgitation clinical trial in Thousand Oaks, CA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Thousand Oaks

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Thousand Oaks site if eligible
  4. 4Begin participation

About This Mitral Regurgitation Study in Thousand Oaks

To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.

Sponsor: Sierra Valve LLC

Who Can Participate

Inclusion 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 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.

Exclusion Criteria

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 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Thousand Oaks?

Yes, this clinical trial (NCT07086534) has an active research site in Thousand Oaks, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mitral Regurgitation Treatment Options in Thousand Oaks, CA

If you're searching for mitral regurgitation treatment options in Thousand Oaks, CA, this clinical trial (NCT07086534) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Thousand Oaks research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mitral regurgitation specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mitral regurgitation clinical trials near you to find additional studies recruiting in your area.

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