La Jolla, CANCT05537753Now EnrollingIRB Ready

Patent Foramen Ovale Clinical Trial in La Jolla, CA

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

Sponsored by Encore Medical Inc.

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Expert Care in La Jolla

Access patent foramen ovale specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related patent foramen ovale treatment provided free

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Check if you qualify for this patent foramen ovale 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 Patent Foramen Ovale Study in La Jolla

The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.

Sponsor: Encore Medical Inc.

Who Can Participate

Inclusion Criteria

Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and/or during Valsalva release
Cryptogenic stroke within the last 270 days; stroke is defined as acute focal neurological deficit, presumed to be due to focal ischemia, and confirmed by MRI or CT to be a new, neuroanatomically relevant cerebral infarct

Exclusion Criteria

Age \<18 years and age \>60 years
Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels
Intracardiac thrombus or tumor
Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina
Left ventricular aneurysm or akinesis
Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitral regurgitation
Aortic valve stenosis (gradient \>40 mmHg) or severe aortic valve regurgitation
Mitral or aortic valve vegetation or prosthesis
Left ventricular ejection fraction \<35%
Other identifiable cause of stroke, including but not limited to aortic arch plaques (protruding \>4 mm into the lumen), large artery atherosclerotic disease, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection
Evidence of a hypercoagulable disorder requiring anticoagulation therapy; this determination will be based on the evaluation of: anticardiolipin antibody (Ab) of the IgG or IgM type, Lupus anticoagulant, B2-glycoprotein-1 Ab, and fasting plasma homocysteine
Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum
Any history of atrial fibrillation/atrial flutter (chronic or intermittent)
Active endocarditis or other untreated infections
Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis (eGFR less than 30)
Severe liver disease (ALT 3X ULN) or documented cirrhosis
Lung disease requiring continuous home oxygen
Uncontrolled hypertension, defined as sustained elevated blood pressure \>160/90 mm Hg on medication
Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent test which must have been collected within the last year)
Anatomical or physiological structures that do not permit TEE
Anticipated need for treatment of structural cardiac defects other than PFO
Concomitant cardiac anomalies requiring an operative procedure
Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis)
Hypersensitivity to contrast medium or nickel
Contraindication to aspirin or clopidogrel
The required sheaths cannot be passed through the relevant vessels for access to the PFO
Vulnerable patient (e.g., incarcerated or cognitively challenged adults); see Section 7.2.1
Subject is unable or unwilling to provide informed consent
Subject is unable to comply with the protocol
Any other clinical reasons for which the patient would not be an appropriate candidate for the study, as determined by the site investigators

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 (NCT05537753) 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.

Patent Foramen Ovale Treatment Options in La Jolla, CA

If you're searching for patent foramen ovale treatment options in La Jolla, CA, this clinical trial (NCT05537753) 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 patent foramen ovale 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 patent foramen ovale clinical trials near you to find additional studies recruiting in your area.

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