Newport Beach, CANCT05172973Now EnrollingIRB Ready

Aortic Valve Insufficiency Clinical Trial in Newport Beach, CA

Access cutting-edge aortic valve insufficiency treatment through this clinical trial at a research site in Newport Beach. Study-provided care at no cost to qualified participants.

Sponsored by Edwards Lifesciences

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Expert Care in Newport Beach

Access aortic valve insufficiency specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related aortic valve insufficiency treatment provided free

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Check if you qualify for this aortic valve insufficiency clinical trial in Newport Beach, 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 Newport Beach

    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 Newport Beach site if eligible
  4. 4Begin participation

About This Aortic Valve Insufficiency Study in Newport Beach

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Sponsor: Edwards Lifesciences

Who Can Participate

Inclusion Criteria

Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
Bioprosthetic valve size suitable for SAPIEN X4 THV
NYHA functional class ≥ II
Heart Team agrees the subject is at high or greater surgical risk
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
Failing valve has moderate or severe paravalvular regurgitation
Failing valve is unstable, rocking, or not structurally intact
Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
Increased risk of THV embolization
Surgical or transcatheter valve in the mitral position
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
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
Clinically significant coronary artery disease requiring revascularization
Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
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
Body mass index \> 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 Newport Beach?

Yes, this clinical trial (NCT05172973) has an active research site in Newport Beach, 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 Valve Insufficiency Treatment Options in Newport Beach, CA

If you're searching for aortic valve insufficiency treatment options in Newport Beach, CA, this clinical trial (NCT05172973) 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 Newport Beach research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic valve insufficiency 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 valve insufficiency clinical trials near you to find additional studies recruiting in your area.

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