Abbott (NYSE:ABT) announced today that a study showed its TactiCath ablation catheter often led to more than a year of freedom from AFib symptoms.
The Persist-End study showed that 89% of patients treated for persistent AFib with the company’s TactiCath contact force ablation catheter, Sensor Enabled (TactiCath SE), remained symptom-free for up to 15 months after the procedure.
According to a news release, the data, presented at the annual meeting of the Heart Rhythm Society, also showed quality of life improvements and a more than 50% reduction in the use of healthcare resources.
The prospective, multi-center, single-arm clinical trial spanning from 2018 to 2021 included 224 patients across 21 sites in the U.S. and Australia. Patients were evaluated for 15 months after cardiac ablation with a primary safety endpoint defined as the rate of primary device and/or procedure-related serious adverse events occurring within seven days of any ablation procedure. Primary efficacy was defined as freedom from documented AFib, atrial flutter or tachycardia 30 seconds or longer, new or increased dose of Class I/III antiarrhythmic drug (AAD), repeat ablation and cardioversion through 15 months.
Abbott said the study met all of its primary safety, effectiveness and quality of life endpoints with a 3.1% rate of serious adverse events, consistent with other studies in the persistent AFib population. In total, 61.6% of patients remained free from arrhythmia recurrence, any new or increased Class I/III AAD, repeat ablation or cardioversion.
“Ablation therapy is an increasingly important option for people living with cardiac arrhythmias because it allows physicians to treat the cause of the arrhythmia at its source. However, it can be a challenging procedure because the right amount of pressure needs to be applied to the heart wall to be effective, but not so much as to cause other problems,” CMO of Abbott’s electrophysiology business Dr. Christopher Piorkowski said in the release. “We developed TactiCath SE to provide clear information on whether the device is making contact with the heart wall and whether the pressure is enough to achieve the therapeutic goals. The outcomes are clear – the system delivers safe and effective results.”