Background: The HeartLight™ endoscopic ablation system (HL-EAS), has proven similar efficacy as irrigated radiofrequency guided pulmonary vein isolation (PVI) in prospective randomized studies though longer procedure times were reported. Most recently, the option of a new ablation mode (RAPID™) was added, during which the laser arc generator is swept around the PV antrum by an integrated motor drive at a pre-defined speed for continuous ablation. We sought to determine the performance of the new EAS (X3).

Methods: The study was prospective, multi-center, and historically controlled (comparison to pivotal HL study). The primary endpoint was ablation time defined as the time from insertion of the X3 catheter into the participant to the end of the last 30-minute wait period. Transtelephonic monitoring was performed starting at 90 days and continued through 12 months. 

Results: A total of 60 patients were enrolled at two centers. Except one all PVs were treated with RAPID mode.  Acute PVI was achieved in 225/228 of these PVs (98.7%). The ablation time, was significantly shorter with X3 than in the HL study (77.3 ± 25.8 min versus 173.8 ± 46.6 min; p<0.0001). Procedure time and fluoroscopy time were also significantly shorter (103.7 ± 32.3 min versus 236.0 ± 52.8min; p<0.0001; 6.9 ± 3.5 versus 35.6 ± 18.2). PVI after the first circular lesion was achieved in 91.6% of PVs (206/225). 

No device related serious adverse event was reported.

The 6-month and 12-month AF-Free rates for X3 compare favorably with the rates reported for HL, 89.5% versus 75.0% and 71.9% versus 61.1%, respectively.

Conclusions: The novel X3 generation EAS allows for rapid PVI by continuous lesion deployment. This was associated with a significant reduction in ablation and procedure times while maintaining the safety and chronic effectiveness

Clinical Trial Registration: NCT03470636