"Persistent AF patients face a higher risk of complications such as stroke, heart failure, and death," said Uri Yaron, Worldwide President of Biosense Webster, Inc. "This approval and data from the PRECEPT study help to further our commitment to advancing AF treatment, providing electrophysiologists with state-of-the-art options for their patients."
The PRECEPT study enrolled a total of 381 patients with documented symptomatic persistent AF who did not respond or were intolerant of one or more AADs (Class I or III). The study was conducted at 27 sites across the United States and Canada.1 The primary effectiveness endpoint was freedom from documented recurrence of atrial flutter/atrial tachycardia episodes of 30 seconds or longer and freedom from additional five failure modes: acute procedural failure, use of a non-study catheter, repeat procedures, use of new/higher dose antiarrhythmic drugs, surgical AF ablation.1 A tailored ablation strategy was used, allowing for pulmonary vein isolation (PVI) and additional left atrial ablations (PVI+) at the operator's discretion based on the patient's disease state.1 The study resulted in a 4.7 percent primary adverse event (PAE) rate which is comparable to PAE rates reported in paroxysmal AF studies using CF-sensing RF catheters.4,5,6
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About Atrial Fibrillation
Atrial fibrillation (AF) is the most common type of cardiac arrhythmia (abnormal heart rhythm) and affects nearly one percent of the population.7 During AF, the upper chambers of the heart, the atria, beat rapidly or in an uncontrolled manner, which can feel like a flutter. When the heart beats erratically, it does not pump blood as efficiently as it should. When oxygen is not being properly delivered to all parts of the body, the patient may feel ill or experience other AF symptoms. AF may not be life-threatening; however, it is important to seek treatment to control the symptoms, as AF can lead to stroke.
As with any medical treatment, individual results may vary. Only a cardiologist or electrophysiologist can determine whether ablation is an appropriate course of treatment. There are potential risks including bleeding, swelling or bruising at the catheter insertion site, and infection. More serious complications are rare, which can include damage to the heart or blood vessels; blood clots (which may lead to stroke); heart attack; or death. These risks need to be discussed with your doctor and recovery takes time. The success of this procedure depends on many factors, including your physical condition and your body's ability to tolerate the procedure. Use care in the selection of your doctors and hospital, based on their skill and experience.