Los Angeles, CANCT03003299Now EnrollingIRB Ready

Aortic Stenosis Clinical Trial in Los Angeles, CA

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

Sponsored by Edwards Lifesciences

Quick Self-Assessment

See if you qualify for this Los Angeles location

Preparing your pre-screening questions…

Expert Care in Los Angeles

Access aortic stenosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related aortic stenosis treatment provided free

Apply for This Los Angeles Location

Check if you qualify for this aortic stenosis clinical trial in Los Angeles, 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 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 Aortic Stenosis Study in Los Angeles

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Sponsor: Edwards Lifesciences

Who Can Participate

Inclusion Criteria

Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
NYHA Functional Class ≥ II.
Heart Team agrees the patient is low to intermediate risk.
Heart Team agrees valve implantation will likely benefit the patient.
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
Severe regurgitation (\> 3+) or stenosis of any other valve
Failing valve has moderate or severe paravalvular regurgitation
Failing valve is unstable, rocking, or not structurally intact
Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
Increased risk of embolization of THV
Known bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
Anatomical characteristics that would preclude safe access to the apex (Transapical)
Evidence of an acute myocardial infarction ≤ 30 days before enrollment
Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
Untreated clinically significant coronary artery disease requiring revascularization
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
Emergency interventional/surgical procedures within 30 days prior to the procedure
Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
Hypertrophic cardiomyopathy with obstruction
LVEF \< 30%
Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
Stroke or transient ischemic attack within 90 days of enrollment
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
Renal insufficiency and/or renal replacement therapy at the time of screening
Active bacterial endocarditis within 180 days of the procedure
Patient refuses blood products
Estimated life expectancy \< 24 months
Positive urine or serum pregnancy test in female subjects of childbearing potential
Currently participating in an investigational drug or another device 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 (NCT03003299) 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.

Aortic Stenosis Treatment Options in Los Angeles, CA

If you're searching for aortic stenosis treatment options in Los Angeles, CA, this clinical trial (NCT03003299) 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 aortic stenosis 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 aortic stenosis clinical trials near you to find additional studies recruiting in your area.

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