La Jolla, CANCT03523416Now EnrollingIRB Ready

Heart Failure Clinical Trial in La Jolla, CA

Access cutting-edge heart failure treatment through this clinical trial at a research site in La Jolla. Study-provided care at no cost to qualified participants.

Sponsored by Edwards Lifesciences

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Expert Care in La Jolla

Access heart failure specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related heart failure treatment provided free

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Check if you qualify for this heart failure clinical trial in La Jolla, 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 La Jolla

    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 La Jolla site if eligible
  4. 4Begin participation

About This Heart Failure Study in La Jolla

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.

Sponsor: Edwards Lifesciences

Who Can Participate

Inclusion Criteria

A primary diagnosis of HFrEF (LVEF ≤ 40%), and
NYHA Class II, III, or IVa heart failure symptoms and
Documentation of at least one of the following in the past 12 months, such as:
Hospitalization for heart failure; or
Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months. Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.
Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA) Refined HFrEF Subgroup

Exclusion Criteria

Severe HF defined as one or more of the following:
Ambulatory NT-proBNP value \>5,000 pg/ml or BNP value \>1,600 pg/ml
Left ventricular end-diastolic diameter (LVEDD) \>8 cm
Left ventricular ejection fraction (LVEF) \< 20%
ACC/AHA Stage D HF or non-ambulatory NYHA Class IV HF
Inotropic infusion (continuous or intermittent) within the past 6 months
Active listing on the cardiac transplant waiting list
More than mild right ventricular dysfunction
Valve disease
Mitral regurgitation \> moderate
Mitral stenosis \> mild
Tricuspid regurgitation \> moderate
Aortic regurgitation \> moderate
Aortic stenosis \> moderate
Body mass index (BMI) ≥45
Myocardial infarction and/or any therapeutic invasive, non-valvular cardiac procedure within the past 3 months, or current indication for coronary revascularization
Stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolus within the past 6 months
Cardiac resynchronization therapy implanted within the past 12 months
Renal insufficiency as determined by serum creatinine (sCr) level \>2.5 mg/dL or estimated glomerular filtration rate (eGFR) \<25 ml/min/1.73 m2
Performance of the 6-minute walk test with a distance \<100 m or \>450 m
Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure
Presence of one or more of the following resting hemodynamic findings:
Mean pulmonary capillary wedge pressure (PCWP) \>35 mmHg
Mean right atrial pressure (RAP) \>15 mmHg
Mean PCWP-mean RAP gradient \< 5 mmHg
Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
Cardiac index \<1.8 L/min/m2

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 La Jolla?

Yes, this clinical trial (NCT03523416) has an active research site in La Jolla, 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.

Heart Failure Treatment Options in La Jolla, CA

If you're searching for heart failure treatment options in La Jolla, CA, this clinical trial (NCT03523416) 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 La Jolla research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure 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 heart failure clinical trials near you to find additional studies recruiting in your area.

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