Charlotte, NCNCT07287436Now EnrollingIRB Ready

Atrial Fibrillation (AF) Clinical Trial in Charlotte, NC

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

Sponsored by Boston Scientific Corporation

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Expert Care in Charlotte

Access atrial fibrillation (af) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related atrial fibrillation (af) treatment provided free

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Check if you qualify for this atrial fibrillation (af) clinical trial in Charlotte, NC

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Why Participate?

  • No-Cost Study Care

  • Local to Charlotte

    Convenient for NC 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 Charlotte site if eligible
  4. 4Begin participation

About This Atrial Fibrillation (AF) Study in Charlotte

The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for anticoagulation therapy to reduce the risk of stroke.

Sponsor: Boston Scientific Corporation

Who Can Participate

Inclusion Criteria

The subject is of legal age to participate in the study per the laws of their respective geography.
The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
The subject has an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.
The subject is deemed to be suitable for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy following WATCHMAN Elite Device implant.
The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
The subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria

The subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment upon study physician's discretion).
The subject has a documented life expectancy of less than 2 years.
The subject is currently enrolled, or plans to enroll, in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed.
The subject has a known contraindication to percutaneous catheterization procedure or is contraindicated for transesophageal echocardiography (TEE) or cardiac computed tomography (CT).
The subject has documented left ventricular ejection fraction (LVEF) \< 30%.
The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment.
The subject has a LAA anatomy that is incompatible with the device selection requirements outlined in the Instructions for Use (IFU).
The subject has a known hypercoagulability disorder, mechanical heart valve in any position, known amyloid cardiomyopathy, or recurrent deep vein thrombosis (DVT).
The subject has known history of complex atheroma with mobile plaque of the descending aorta and/or aortic arch.
The subject has estimated glomerular filtration rate (eGFR) \<30 ml/min (chronic kidney disease stage IV or V) or is on dialysis.
The subject has a cardiac tumor.
The subject has signs/symptoms of acute or chronic pericarditis.
The subject has an active infection.
The subject has documented surgical closure of the left atrial appendage.
The subject has a history of atrial septal repair or has an ASD/PFO device.
The subject had a prior procedure with any commercial LAAC device that was either aborted or unsuccessful.
The subject is contraindicated to oral short-term anticoagulation post-implant.
The subject is contraindicated to Aspirin and P2Y12 inhibitor.
The subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy.
The subject has an active bleed, or the subject has a major bleeding event per ISTH definitions within the 90 days prior to enrollment. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are a further exclusion regardless of timing of the bleeding event.
The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
The subject has a documented myocardial infarction (MI) as either a non-ST elevation MI (NSTEMI) or an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to enrollment.
The subject had or is planning to have any cardiac or non-cardiac invasive or surgical procedure within 30 days prior to or 60 days after the WATCHMAN Elite Device implant (including, but not limited to: cardioversion, percutaneous coronary intervention (PCI), cataract surgery, endoscopy, etc.)
The subject had cardiac ablation within the 60 days prior to or plans to have a cardiac ablation within 60 days after the WATCHMAN Elite implant
Platelet count ≤ 100,000/μL Pre-procedure Imaging Anatomical Exclusion Criteria:
The subject has a LAA anatomy that is incompatible with the device selection requirements outlined in the Instructions for Use (IFU).
The subject has an existing pericardial effusion with a circumferential echo-free space \> 5mm, a significant mitral valve stenosis (i.e., MV area \<1.5 cm2), and/or there is evidence (clinically or echocardiographically) of tamponade physiology.
The subject has intracardiac thrombus, LAA sludge (gelatinous, non-adherent, intracavitary echo-density more layered than dense spontaneous echo contrast (SEC) seen continuously throughout cardiac cycle) or dense SEC visualized by TEE prior to device implant.
The subject has a high-risk patent foramen ovale (PFO) with an atrial septal aneurysm excursion \> 15mm or length \> 15mm.

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 Charlotte?

Yes, this clinical trial (NCT07287436) has an active research site in Charlotte, NC 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 (AF) Treatment Options in Charlotte, NC

If you're searching for atrial fibrillation (af) treatment options in Charlotte, NC, this clinical trial (NCT07287436) 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 Charlotte research site is actively enrolling participants for this clinical trial. You'll receive care from experienced atrial fibrillation (af) 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 (af) clinical trials near you to find additional studies recruiting in your area.

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