Is NCT05723926 recruiting in Chattanooga, TN?

Yes, NCT05723926 is currently recruiting participants at its Chattanooga, TN location. This atrial fibrillation clinical trial is actively enrolling qualified participants.

How do I join the atrial fibrillation clinical trial in Chattanooga?

To join this clinical trial in Chattanooga, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Chattanooga clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Atrial Fibrillation Clinical Trial in Chattanooga, TN

About This Atrial Fibrillation Study in Chattanooga

Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). This randomized control trial aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke vs. only OAC.

Sponsor: Javelin Medical

Who Can Participate

Inclusion Criteria

Documented history of clinical AF

History of ischemic (i.e. non-hemorrhagic) stroke including symptoms of stroke resolving within 24 hours with positive neuro-imaging, meeting one of the following criteria: Group 1: Patient was on OAC at time of index stroke, with index stroke occurring \< 6 week from enrollment Group 2: Patient was not on OAC at time of stroke, with index stroke occurring \< 6 weeks from enrollment Group 3: Patient was on OAC at time of index stroke, with index stroke occurring 6 to 52 weeks from enrollment

Planned use of a Vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC) for the duration of the trial

Patient able to tolerate single antiplatelet therapy in addition to oral anticoagulation for 6 months, in the opinion of the investigator

Bilateral ultrasound or angiogram demonstrating all of the following:

Inner common carotid artery diameter range: ≥5.3 mm and ≤8.8 mm

Accessibility: up to 40 mm from skin to common carotid artery center

Implantation segment free of any atherosclerotic disease

Absence of carotid dissection or pre-existing stent(s) in common carotid artery

Absence of ≥50% stenosis of the internal carotid arteries as seen on ultrasound or angiography (CTA, MRA or DSA) i. For ultrasound, calculate the percentage of carotid stenosis using the Society of Radiologists in Ultrasound Consensus Criteria for Carotid Stenosis, where ≥50% stenosis is defined by internal carotid artery peak systolic velocity of ≥125 cm/sec, internal/common carotid peak systolic velocity ratio of 2 or more and end diastolic velocity of ≥40 cm/sec, or evidence of near occlusion. ii. For angiography, calculate the percentage of carotid stenosis using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria (\[D - N\]/D x 100, where N is the luminal diameter at the site of maximal narrowing and D is the diameter of normal distal internal carotid artery beyond the bulb where the artery walls are parallel.

Provision of informed consent

Exclusion Criteria

Contraindication to oral anticoagulation (e.g. history of intracranial hemorrhage, known hereditary or acquired coagulation disorders, or recurrent major bleeding)

Contraindication to additional single antiplatelet therapy for 6 months from randomization

Previously documented 50% or greater stenosis, or high-risk plaque in the opinion of the investigator, of the common carotid, internal carotid, subclavian, vertebral, or intracranial arteries that has not been treated with a revascularization procedure (i.e. stent or angioplasty)

Visualized active (acute/subacute) cervical or intracranial arterial thrombus (i.e. free-floating) on computed tomography (CT), magnetic resonance (MR), or digital subtraction (DS) angiography that is at risk of causing additional stroke/brain injury

Previously documented aneurysm of the internal carotid artery or its branches (i.e. ophthalmic, posterior communicating, anterior choroidal, anterior cerebral and middle cerebral arteries) that is 6 mm or greater in diameter.

Prior surgery or radiation of the neck at the implantation segment

Pre-existing percutaneous left atrial appendage occlusion device that was implanted after most recent ischemic stroke

Planned left atrial appendage occlusion procedure

Female who is pregnant or non-postmenopausal female who is not willing to use an effective method of birth control during duration of the trial

Overt systemic infection

Known sensitivity to nickel or titanium metals, or their alloys

Active participation in another investigational drug or device treatment trial

Any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the trial

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 Chattanooga?

Yes, this clinical trial (NCT05723926) has an active research site in Chattanooga, TN 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 Chattanooga, TN

If you're searching for atrial fibrillation treatment options in Chattanooga, TN, this clinical trial (NCT05723926) 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 Chattanooga 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.

Atrial Fibrillation Clinical Trial in Chattanooga, TN

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