“Single-shot” conformable catheter shows promising efficacy in paroxysmal atrial fibrillation

A first-in-human trial showed high efficacy, while serious adverse events were rare, using a shape-adaptive catheter in patients with paroxysmal atrial fibrillation (AF). This approach can offer mapping and ablation in a single procedure.

This first-in-human prospective, multicentre trial (NCT05144503, NCT05115214) assessed the safety, performance, and effectiveness of treating paroxysmal AF using a conformable pulmonary vein isolation catheter [1]. Using this conformable catheter with a shape-adaptive design, mapping and radiofrequency ablation can be performed in 1 procedure.

Participants were included if they had at least 2 documented ECG episodes of AF within 1 year of enrolment and recurrent, self-terminating AF, as well as failure or intolerance to at least 1 class I–IV anti-arrhythmic drug. A total of 85 patients were enrolled and treated, including 35 patients in the highest waveform cohort PULSE3.

At 1 year, 81.8% (95% CI 70.2–89.2) of the participants were arrhythmia-free in the total cohort, while in the PULSE3 cohort, this rate was 100% (95% CI 80.6–100). One patient (1.2%) had a serious adverse event of diplopia and vertigo (remission within 2 days). MRI analyses of the oesophagus showed minor erythaema, injury to the mucosa, and post-anaesthesia intubation irritation in 1 patient each; however, only the latter was considered procedure-related.

Remapping at day 75 post-ablation showed an increase in durability, with increasing pulse waveform reaching almost 100% in the PULSE3 cohort. “In this first-in-human study, the conformable pulsed field ablation catheter was efficacious, safe, and clinically effective for performing pulmonary vein isolation, and created durable lesions,” concluded Prof. Vivek Reddy (Icahn School of Medicine at Mount Sinai, NY, USA). However, the efficacy of this catheter is currently unknown in other lesion sets or other populations, such as patients with non-paroxysmal AF.

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   1. Reddy VY, et al. First-in-human clinical series of a novel conformable "single-shot" pulsed field ablation catheter for pulmonary vein isolation. Late-Breaking Science: ablation. EHRA Congress 2024, 7–9 April, Berlin, Germany.

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Posted on 29 April 20241 May 2024