In the study, 89% of patients treated with the company’s TactiCath SE for persistent AFib experienced no symptoms for up to 15 months after the procedure
Abbott headquarters. (Credit: Abbott)
Abbott announced that data from the PERSIST-END study showed positive outcomes for its TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in patients with persistent atrial fibrillation (AFib).
In the study, 89% of patients treated with the company’s catheter for persistent AFib experienced no symptoms for up to 15 months after the procedure.
The data also showed that patients reported significant quality-of-life improvements and a more than 50% reduction in the use of health care resources.
TactiCath SE has been designed to facilitate cardiac ablation procedure, a minimally invasive method to selectively disrupt the area of the heart generating abnormal heartbeats.
The device is used in combination with Abbott’s EnSite X EP System, the Advisor HD Grid Mapping catheter, and EnSite Omnipolar Technology (OT).
It was previously approved for the treatment of paroxysmal AFib and results from the PERSIST-END study had supported its approval in persistent AFib, last year.
Abbott electrophysiology business chief medical officer Christopher Piorkowski said: “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.
“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.”
PERSIST-END was a multi-centre, single-arm clinical trial conducted on 224 patients at 21 investigational sites in the US and Australia, from 2018 to 2021.
The study participants were assessed for safety, efficacy, and quality of life measures, for 15 months after the cardiac ablation procedure.
The rate of primary device or procedure-related serious adverse events (SAEs) within seven days of any ablation procedure is the primary safety endpoint of the study.
Freedom from AFib, atrial flutter or tachycardia, a new or increased dose of Class I/III antiarrhythmic drug (AAD), repeat ablation, and cardioversion include the primary efficacy.
The study has met all the primary safety, effectiveness and quality of life endpoints, with only 3.1% serious adverse events, which is consistent with other studies on the population.
The patients’ Atrial Fibrillation Effect on the QualiTy-of-life (AFEQT) score increased by more than 27 points after three months and more than 32 points after 15 months, said Abbott.
PERSIST-END study site principal investigator Douglas Gibson said: “Like many arrhythmias, persistent AFib can be difficult to treat and to date, we have had relatively few approaches approved specifically to treat this condition.
“The results of the PERSIST-END study show that Abbott’s TactiCath SE can help physicians ensure the majority of our persistent AFib patients will remain symptom-free following their therapy and will go on to experience dramatic improvements in their quality of life.”