HeartLight X3 pivotal study meets safety and efficacy endpoints

HeartLight X3’s direct visualisation feature

CardioFocus has announced that results from the HeartLight X3 Pivotal Study have been published online in the journal Circulation: Arrhythmia and Electrophysiology (CircEP), showing that all endpoints of the pivotal study were achieved.

The results demonstrated significantly faster pulmonary vein isolation (PVI) ablation and procedures times with the HeartLight X3 System compared to the previous generation system, the HeartLight Endoscopic Ablation System, and with comparable safety and efficacy.

The HeartLight X3 System allows the electrophysiologist (EP) to visualise the PVI procedure which, combined with the universally compliant Excalibur Balloon, allows the EP to achieve stable, effective contact with the pulmonary vein, CardioFocus said in a press release.

The primary endpoint of the study was to test whether ablation time with the HeartLight X3 system was less than the ablation time with the current HeartLight system. Results from this study showed the ablation time was significantly shorter with the X3 than the original HeartLight device (77.3±25.8 minutes versus 173.8±46.6 minutes; p<0.0001). Ablation time included a 30-minute post-ablation waiting period.

The secondary acute endpoint looked at procedure time, which was significantly shorter with X3 then the original HeartLight device (103.7±32.3 minutes versus 236±52.8 minutes; p<0.0001). Additionally, fluoroscopy time was significantly shorter with the new X3 device (6.9±3.5 versus 35.6±18.2; p<0.0001).

The HeartLight X3 system also showed improvement in chronic effectiveness at both six and 12 months. Freedom from symptomatic atrial fibrillation reported at six months was 89.5% versus 75% and 71.9% versus 61.1% at 12 months, for HeartLight X3 and conventional HeartLight, respectively.


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