Loma Linda, CANCT05147792Now EnrollingIRB Ready

Atrial Fibrillation Clinical Trial in Loma Linda, CA

Access cutting-edge atrial fibrillation treatment through this clinical trial at a research site in Loma Linda. Study-provided care at no cost to qualified participants.

Sponsored by Conformal Medical, Inc

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Expert Care in Loma Linda

Access atrial fibrillation specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related atrial fibrillation treatment provided free

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Check if you qualify for this atrial fibrillation clinical trial in Loma Linda, CA

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Why Participate?

  • No-Cost Study Care

  • Local to Loma Linda

    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 Loma Linda site if eligible
  4. 4Begin participation

About This Atrial Fibrillation Study in Loma Linda

The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.

Sponsor: Conformal Medical, Inc

Who Can Participate

Inclusion Criteria

Male or non-pregnant female aged ≥18 years
Documented non-valvular AF (paroxysmal, persistent, or permanent)
High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care
Able to comply with the protocol-specified medication regimen and follow-up evaluations
The subject (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).

Exclusion Criteria

Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO/ASD closure device, history of surgical ASD repair or history of surgical LAAO closure)
Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or prosthetic mechanical heart valve)
History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
Documented active systemic infection
Symptomatic carotid artery disease (defined as \>50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \<50% stenosis noted at the site of prior treatment
Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure
Recent (within 30 days of index procedure) stroke or transient ischemic attack
Recent (within 30 days of index procedure) myocardial infarction
Vascular access precluding delivery of implant with catheter-based system
Severe heart failure (New York Heart Association Class IV)
Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant
Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)
Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3
Known allergy, hypersensitivity or contraindication to aspirin, heparin, or that would preclude any P2Y12 inhibitor therapy, or to device materials (e.g., nickel, titanium), or the subject has contrast sensitivity that cannot be adequately pre-medicated
Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
Unable to undergo general anesthesia
Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years
A condition which precludes adequate transesophageal echocardiographic assessment Echo exclusion criteria:
Left atrial appendage anatomy which cannot accommodate a commercially available control device or the CLAAS Implant per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for both the investigational (CLAAS) and a commercially available device in order to be enrolled in the trial)
Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by TEE
Left ventricular ejection fraction (LVEF) \<30%
Moderate or large pericardial effusion \>10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
Atrial septal defect that warrants closure
High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \> 15 mm) or large shunt (early \[within 3 beats\] and/or substantial passage of bubbles, e.g., \>20)
Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2)
Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
Evidence of cardiac tumor

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 Loma Linda?

Yes, this clinical trial (NCT05147792) has an active research site in Loma Linda, 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.

Atrial Fibrillation Treatment Options in Loma Linda, CA

If you're searching for atrial fibrillation treatment options in Loma Linda, CA, this clinical trial (NCT05147792) 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 Loma Linda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced atrial fibrillation 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 atrial fibrillation clinical trials near you to find additional studies recruiting in your area.

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