Boston Scientific said that the FARAPULSE Pulsed Field Ablation (PFA) System has met the primary efficacy and safety endpoints in the ADVENT study in patients with paroxysmal, or intermittent, atrial fibrillation (AF).

FARAPULSE PFA System is a nonthermal treatment in which electric fields are used for selectively ablating heart tissue in AF patients.

The data indicated that the FARAPULSE PFA System was on par with standard-of-care therapies, thereby achieving the primary efficacy and safety endpoints. This was despite the majority of physicians involved having previous experience exclusively with thermal ablation, said Boston Scientific.

The endpoints of the ADVENT trial were assessed using Bayesian statistical approaches.

ADVENT is the first randomised clinical trial to compare the efficacy and safety of the FARAPULSE PFA System directly against standard-of-care ablation methods, either radiofrequency or cryoablation.

The multicentre, prospective, and randomised controlled study recruited 607 patients in the US having paroxysmal AF and who had been unsuccessfully treated in the past with at least one anti-arrhythmic medication.

Over the course of 12 months, the single-procedure, the PFA arm of the study demonstrated a single-procedure, off-drug treatment success rate of 73.3%. The thermal arm, on the other hand, achieved a rate of 71.3%.

According to Boston Scientific, the figures aligned with the primary efficacy endpoint.

The primary composite safety endpoint, which encompasses acute and chronic device- and procedure-related serious adverse events occurring within seven days of the procedure, was achieved. This was accompanied by a comparably low adverse event rate of 2.1% in the PFA arm of the trial and 1.5% in the thermal group.

The study’s secondary safety endpoint revealed the superiority of the FARAPULSE PFA System, exhibiting a substantially lower post-ablation narrowing of the pulmonary veins at three months (0.9%) compared to the thermal ablation group (12%).

Also, significantly shorter ablation times and reduced variability were observed within the PFA arm of the study using the FARAPULSE PFA System, with a mean of 29.2 minutes and a standard deviation of 14.3 minutes. This is in comparison to a mean of 50 minutes and a standard deviation of 24.6 minutes in the thermal arm.

Boston Scientific senior vice president and global chief medical officer Kenneth Stein said: “These data underscore the superior procedural efficiency of this novel technology, and real-world use continues to yield strong safety and efficacy outcomes.

“The performance of the FARAPULSE PFA System in this trial is an encouraging sign of the potential utilisation of the device in the U.S. and we look forward to further studying the system for the treatment of patients with persistent AF in the ADVANTAGE AF clinical trial, which began enrolment earlier this year.”

The FARAPULSE PFA System secured CE Mark in 2021.