Los Angeles, CANCT05172960Now EnrollingIRB Ready

Aortic Stenosis, Severe Clinical Trial in Los Angeles, CA

Access cutting-edge aortic stenosis, severe 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

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Preparing your pre-screening questions…

Expert Care in Los Angeles

Access aortic stenosis, severe specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related aortic stenosis, severe treatment provided free

Apply for This Los Angeles Location

Check if you qualify for this aortic stenosis, severe clinical trial in Los Angeles, CA

Secure & Confidential

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, Severe Study in Los Angeles

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Sponsor: Edwards Lifesciences

Who Can Participate

Inclusion Criteria

Severe, calcific AS
Native aortic annulus size suitable for SAPIEN X4 THV
NYHA functional class ≥ II
The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
Aortic valve is unicuspid, bicuspid or non-calcified
Pre-existing mechanical or bioprosthetic valve in any position
Severe aortic regurgitation (\> 3+)
Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
Left ventricular ejection fraction \< 20%
Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation
Increased risk of coronary artery obstruction after THV implantation
Myocardial infarction within 30 days prior to the study procedure
Hypertrophic cardiomyopathy with subvalvular obstruction
Subjects with planned concomitant ablation for atrial fibrillation
Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)
Endocarditis within 180 days prior to the study procedure
Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
Renal insufficiency and/or renal replacement therapy
Leukopenia, anemia, thrombocytopenia
Inability to tolerate or condition precluding treatment with antithrombotic therapy
Hypercoagulable state or other condition that increases risk of thrombosis
Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
Subject refuses blood products
BMI \> 50 kg/m2
Estimated life expectancy \< 24 months
Female who is pregnant or lactating
Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
Participating in another investigational drug or device study that has not reached its primary endpoint
Subject considered to be part of a vulnerable population

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 (NCT05172960) 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, Severe Treatment Options in Los Angeles, CA

If you're searching for aortic stenosis, severe treatment options in Los Angeles, CA, this clinical trial (NCT05172960) 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, severe 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, severe clinical trials near you to find additional studies recruiting in your area.

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