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Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
What is atrial fibrillation?
In atrial fibrillation the heart's upper chambers, the atria, quiver chaotically instead of beating in rhythm, so the heart beats irregularly and often too fast. Some people feel palpitations, breathlessness, fatigue, or dizziness; others feel nothing and learn of it from a routine check or a smartwatch alert. The real problem is that blood pools in the quivering atria and can form clots, which travel to the brain and cause stroke; strokes from AFib tend to be larger and more disabling than others. AFib becomes more common with age, high blood pressure, heart failure, sleep apnea, obesity, diabetes, heavy alcohol use, and thyroid disease, and it is classified as paroxysmal (comes and goes), persistent (lasts more than a week), or permanent.
Treatment has two goals. The first is preventing stroke, usually with an anticoagulant such as apixaban or rivaroxaban, chosen using a risk score; for people who cannot take blood thinners, a device can close the atrial appendage where most clots form. The second is controlling the rhythm or the rate, with medicines or with catheter ablation, which creates small scars that block the faulty electrical signals. Current guidelines favor earlier rhythm control than in the past. The research questions are practical: can a safer blood thinner protect against stroke without the bleeding that makes people stop taking them; can newer ablation technology make the procedure safer and more durable; and does everyone with occasional AFib need a blood thinner every day, or only when the rhythm actually appears. Our medical device clinical trials page covers the ablation and closure devices being tested.
Pulsed field ablation and what is new in AFib treatment
Traditional ablation burns or freezes heart tissue to block abnormal signals, and the heat or cold can injure the esophagus, phrenic nerve, or pulmonary veins nearby. Pulsed field ablation delivers very short, high voltage electrical pulses that open pores in heart muscle cells while leaving other tissue types largely unharmed. The first systems were approved by the FDA in December 2023 and early 2024, and large registries are now tracking long term safety and whether AFib stays away longer. The other major change is in blood thinners: factor XI inhibitors target a clotting protein involved in forming harmful clots but less important for stopping bleeding, and several are in Phase 3 trials against apixaban, the current standard. If they work, they would be the first new class of anticoagulant in more than a decade.
Types of atrial fibrillation clinical trials
Anticoagulant trials. Factor XI inhibitors compared with standard blood thinners for stroke prevention, and studies of how long and when to take anticoagulants, including the smartwatch guided REACT-AF trial.
Ablation trials. Long term follow up of pulsed field ablation, comparisons of ablation approaches, and ablation in people with heart failure or persistent AFib.
Device trials. Left atrial appendage closure devices and what blood thinning regimen to use after them.
Lifestyle and risk factor trials. Alcohol reduction programs, weight loss, and sleep apnea treatment, all of which reduce AFib episodes.
Post surgery AFib trials. Preventing the AFib that commonly follows heart surgery, for example with magnesium.
Detection studies. Wearables and patches that find undiagnosed AFib, often enrolling people with risk factors but no diagnosis.
New to research? Read how informed consent works, especially for device studies.
Who can participate in atrial fibrillation clinical trials?
Anticoagulant trials enroll adults with documented AFib and a stroke risk score high enough that a blood thinner is recommended, often excluding people with mechanical heart valves or very high bleeding risk. Ablation trials enroll people with symptomatic AFib, usually paroxysmal or persistent, who are candidates for the procedure, often after a medicine has failed. The smartwatch guided trial enrolls people 22 to 85 with paroxysmal AFib and low to moderate risk who are willing to wear a watch and take anticoagulants only when signaled. Lifestyle trials have wide doors. Detection studies enroll people at risk with no diagnosis. Eligibility always varies by study; our guide covers eligibility criteria.
Types of AFib, and why they matter for trials
Paroxysmal. Episodes that start and stop on their own, usually within a week. The usual target of ablation trials and of the smartwatch guided anticoagulation study.
Persistent. Lasts more than a week or needs treatment to stop. Ablation is harder, and several device trials focus here.
Long standing persistent and permanent. Continuous AFib for more than a year, or AFib that doctor and patient have decided not to try to convert. Trials focus on rate control and stroke prevention.
Study titles use these terms and often add "symptomatic" or a stroke risk score. Your AFib type, whether you take a blood thinner, and whether you have had an ablation tell you which studies fit.
How to enroll in an atrial fibrillation clinical trial
Identify your trial. Use the filters. Titles say "paroxysmal" or "persistent" and name the approach: anticoagulant, ablation, device, or lifestyle.
Select your preferred location. Enter your city or state. Anticoagulant trials run at dozens of sites; ablation trials at electrophysiology centers.
Explore study details. Click "Learn More" for the AFib type required, current blood thinner rules, and the visit schedule.
Complete the health profile. Click "Get started" to begin the 5-step application. Have three things ready: your AFib type and when it was diagnosed, your current blood thinner and heart medicines, and any prior ablation or cardioversion.
Submit the application. A clinical trial coordinator reviews it and contacts you. Nothing is decided until informed consent, and participation is voluntary at every step.