Novel radiofrequency catheter achieves performance goals in patients with AF
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A novel multielectrode radiofrequency balloon catheter achieved its safety and effectiveness performance goals in the STELLAR investigational device exemption study, researchers reported at the AF Symposium.
For the STELLAR trial, researchers performed catheter ablation in 257 patients (mean age, 60 years; 65% men) with symptomatic, drug-refractory paroxysmal atrial fibrillation. The procedure consisted of pulmonary vein isolation with a balloon catheter (Heliostar, Biosense Webster) and confirmation of isolation with a diagnostic catheter (Lassostar, Biosense Webster), as well as use of a 3D electroanatomical mapping system.
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“With the growing prevalence of AFib, it is important that innovative tools are evaluated in various markets and patient populations to deliver value to patients across regions,” Sandeep Goyal, MD, FHRS, director of the electrophysiology lab at Piedmont Atlanta Hospital, who served as an investigator in the STELLAR study, said in a press release. “The results of this study provide further evidence of how [radiofrequency] balloon catheters can be an important tool for electrophysiologists when treating AFib.”
The primary effectiveness endpoint was 12-month freedom from documented AF, atrial flutter or atrial tachycardia of at least 30 seconds or continuously recorded on a standard 12-lead ECG. The Kaplan-Meier estimate at 12 months was 67.7%, with a 97.5% lower confidence bound of 61.9%, beating the performance goal of 50%, according to the researchers.
The rate of primary adverse events was 5.1%, beating the performance goal of 14%, Goyal and colleagues found.
In the per-protocol population of 238 patients, entrance block in targeted pulmonary veins was achieved in 100%, and pulmonary vein isolation without a focal catheter was achieved in 94.1%, according to the researchers.
The rate of clinical success, defined as time to 12-month symptomatic atrial arrhythmia recurrence, was 77.7%, and the rate of 12-month freedom from repeat ablation for AF/atrial flutter/atrial tachycardia was 92.2%.
The Atrial Fibrillation Effect on Quality of Life score improved as early as 3 months and rose a mean of 36.1 points between baseline and 12 months, according to the researchers.
Class I/III antiarrhythmic drug use dropped from 93.3% at baseline to 6.6% at 12 months, whereas use of direct current cardioversion fell from 12.2% at baseline to 0% at 12 months, Goyal and colleagues found.
The system is not yet approved for commercial use in the United States.
Reference:
- Biosense Webster. www.prnewswire.com/news-releases/late-breaking-data-on-pulmonary-vein-isolation-with-heliostar-balloon-ablation-catheter-presented-at-af-symposium-2023-301738674.html. Published Feb. 3, 2023. Accessed Feb. 9, 2023.
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Goyal S, et al. Late Breaking Clinical Trials and First Report Investigations and Best Abstract Award. Presented at: AF Symposium; Feb. 2-4, 2023; Boston.
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