Los Angeles, CANCT04905017Now EnrollingIRB Ready

Tricuspid Regurgitation Clinical Trial in Los Angeles, CA

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

Sponsored by Trisol Medical

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Expert Care in Los Angeles

Access tricuspid regurgitation specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related tricuspid regurgitation treatment provided free

Apply for This Los Angeles Location

Check if you qualify for this tricuspid regurgitation clinical trial in Los Angeles, CA

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Why Participate?

  • No-Cost Study Care

  • Local to Los Angeles

    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 Los Angeles site if eligible
  4. 4Begin participation

About This Tricuspid Regurgitation Study in Los Angeles

The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).

Sponsor: Trisol Medical

Who Can Participate

Inclusion Criteria

Age \>18 years.
Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
New York Heart Association (NYHA) Functional Class II to IVa.
Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricuspid valve replacement as determined by the local Heart Team.
Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation, and Guideline-Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.
Male or non-pregnant female.
Participant understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
Participant is willing and able to comply with the specified study requirements and follow-up evaluations.
Participant is anatomically suitable for the Trisol system, including trans-jugular access as per imaging requirements, and is approved by the Subject Screening Committee

Exclusion Criteria

Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
Stroke or transient ischemic event within the previous 90 days.
Acute myocardial infarction within the previous 90 days.
Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
Untreated clinically significant coronary artery disease requiring revascularization.
Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within the previous 30 days.
New or untreated right heart chamber or/and superior vena cava intracardiac mass, thrombus, or vegetation.
Systolic pulmonary arterial pressure (sPAP) \> 80 mmHg as measured by pulmonary pressure catheter.
Severe RV dysfunction with RV Stroke Work Index (RVSWI) g/m2/beat \<400 and Pulmonary Artery Pulsatile index (PAPi) \<2.
Ongoing sepsis, including active endocarditis.
Active infection requiring current antibiotic therapy.
Known bleeding diathesis or hypercoagulable state.
Blood dyscrasias as defined: leukopenia (WBC \<3000 cells/mm3), thrombocytopenia (platelet count \<50,000 cells/mm3).
Active gastrointestinal (GI) bleeding or history of GI bleed within the previous 60 days that would preclude anticoagulation.
LVEF \<25% as measured by resting echocardiogram within 30 days prior to index procedure.
Patients in whom transesophageal echocardiography is contraindicated.
Aortic, mitral or pulmonary valve disease (severe stenosis or severe regurgitation) requiring intervention or performed within 90 days prior to enrollment.
Severe tricuspid valve stenosis.
Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days prior to index procedure.
Need for emergent or urgent non cardiac surgery for any reason.
Contraindication or known allergy to device components, anticoagulation therapy with a vitamin K antagonist, or to contrast media that cannot be adequately premedicated.
History of cardiac transplantation, or participant currently listed for urgent transplant (e.g., UNOS Status 1).
Presence of any known life-threatening non-cardiac disease that will limit the subject's life expectancy to less than one year.
Contraindication or known hypersensitivity to anticoagulant therapy and/or antiplatelet therapy.
Venous anatomy unsuitable for implant delivery.
Pacemaker or ICD lead present that would prevent appropriate valve placement.
Active COVID-19 infection.
Comorbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.
Previously enrolled in this study or currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

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 Los Angeles?

Yes, this clinical trial (NCT04905017) has an active research site in Los Angeles, 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.

Tricuspid Regurgitation Treatment Options in Los Angeles, CA

If you're searching for tricuspid regurgitation treatment options in Los Angeles, CA, this clinical trial (NCT04905017) 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 Los Angeles research site is actively enrolling participants for this clinical trial. You'll receive care from experienced tricuspid 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 tricuspid regurgitation clinical trials near you to find additional studies recruiting in your area.

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Secure · Expert Care · Los Angeles, CA