Thousand Oaks, CANCT05913908Now EnrollingIRB Ready

Tricuspid Regurgitation Clinical Trial in Thousand Oaks, CA

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

Sponsored by CroiValve Limited

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Expert Care in Thousand Oaks

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

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

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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 Tricuspid Regurgitation Study in Thousand Oaks

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Sponsor: CroiValve Limited

Who Can Participate

Inclusion Criteria

Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
Patient is symptomatic despite medical therapy.
The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
Age ≥18 years
The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.

Exclusion Criteria

Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
Moderate or greater tricuspid valve stenosis.
Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
Ejection Fraction (EF) \<25%
Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation
Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg
Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
Severe respiratory instability with continuous use of home oxygen
Severe right ventricular dysfunction
Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI.
Stroke or transient ischemic event within 90 days prior to the index procedure
Acute myocardial infarction within 30 days before the index procedure
Renal insufficiency (eGFR \<25 ml/min) or currently on chronic dialysis
Active endocarditis within 6 months of the index procedure
Pulmonary embolism or deep vein thrombosis within the last 6 months
Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure
Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
Life expectancy \<1 year
Active infections requiring current antibiotic therapy
Known severe liver disease
Is on the waiting list for a transplant or has had a prior heart or lung transplant
Known active peptic ulcer or active GI bleed
Unable to take anticoagulant therapy
Any known major coagulation abnormalities, thrombocytopenia, platelets \< 50,000/ml or severe anemia Hb \<8 g/dl
Known patient is actively abusing drugs
Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium
Patients who are pregnant or intend to become pregnant
Any condition making it unlikely the Patient will be able to complete all protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result

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 (NCT05913908) 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.

Tricuspid Regurgitation Treatment Options in Thousand Oaks, CA

If you're searching for tricuspid regurgitation treatment options in Thousand Oaks, CA, this clinical trial (NCT05913908) 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 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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