CardioFocus Releases Positive Pulsed Field Ablation Data

CardioFocus, a company specializing in ablation treatment for cardiac arrhythmias, has published 12-month results from its ECLIPSE AF trial in the journal Circulation: Arrhythmia & Electrophysiology.

ECLIPSE AF was a multi-center, single-arm prospective first-in-human study to evaluate CardioFocus’ Centauri system with commercial focal ablation catheters. 82 patients were enrolled and treated at two centers in the European Union (EU).

Results demonstrated 90.2% 12-month freedom from clinically significant atrial arrhythmia in paroxysmal atrial fibrillation (AFib) patients undergoing de novo pulmonary vein isolation (PVI) using three commercial contact-force sensing focal catheters with the Centauri system’s optimized WAVE1 pulsed field ablation (PFA) waveform.

The system has since received CE mark approval and is sold in the EU and UK. It’s been used with Abbott’s TactiCath sensor enabled, Boston Scientific’s IntellaNav StablePoint, and Johnson & Johnson MedTech’s ThermoCool SmartTouch ablation catheters in over 6,000 patients.

Paroxysmal and persistent AFib patients were treated in the study, with 80.2% 12-month freedom from clinically significant atrial arrhythmia. The waveform was optimized with invasive 90-day remapping and showed overall chronic PVI durability rate of 89%, per pulmonary vein, in patients treated in the optimized PFA cohorts.

Dr. Ante Anić, Head of Electrophysiology, University Hospital Split, Split, Croatia, and Principal Investigator of the study said that waveform science is key to deliver safe, effective therapy with pulsed electric fields.

“Along with my extensive clinical experience with PFA technologies, the study results in this peer-reviewed publication confirm that using a traditional point-by-point workflow with focal catheters and an optimized waveform will deliver excellent clinical results,” said Dr. Anić. “In only a few seconds per application we can achieve excellent ablation depths that produce durable PVI lesions and high rates of freedom from AF while retaining an excellent safety profile.”

Dr. Johan Vijgen, Division Chief of Electrophysiology at Jessa Hospital, Hasselt, Belgium, and Co-Investigator in the study said performing remapping in the study was integral to optimizing the PFA waveform and procedural workflow.

“The iterative process of assessing and improving the index ablation treatment strategy resulted in durable PVI and exceptional long-term arrhythmia survival rates,” Dr. Vijgen explained.

“We are committed to advancing the science of PFA in electrophysiology,” added CardioFocus CEO Steve Ogilvie. “We customize our proprietary pulsed electric field waveforms with each catheter system to deliver precise treatments to improve patient outcomes and we are thrilled with the excellent results in the ECLIPSE AF clinical study.”

Last month, the company announced the first series of patients had been treated with its investigational OptiShot PFA system to treat paroxysmal AFib as part of its VISION AF clinical trial.