CardioFocus Finishes First-in-Human Pulsed Field Ablation Cases in VISION AF Trial

CardioFocus announced the first series of patients treated with its investigational OptiShot pulsed field ablation (PFA) system to treat paroxysmal atrial fibrillation (AFib) as part of its VISION AF clinical trial.

Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Hospital and Prof. Petr Neužil, Chief of Cardiology at Na Homolce Hospital, performed the first cases at Na Homolce Hospital, Prague, Czech Republic.

The first-in-human trial will treat up to 50 patients in the following months with a 12-month follow-up planned. This includes crucial remapping procedures to validate the novel technology’s efficacy.

“The OptiShot balloon catheter is unique among the advanced generation of PFA catheters, with its ability to deliver circumferential lesions to the pulmonary veins with endoscopic visual confirmation of electrode-tissue contact,” said Dr. Reddy. “Direct contact confirmation made me more confident that our acute treatment strategy with this system may provide good long-term outcomes.”

Professor Petr Neužil added, “The ultra-compliant balloon allows for adaptation to all anatomies with unparallelled tissue contact and precise pulsed electric field energy delivery. This design is focused on raising the bar for patient outcomes and we look forward to continuing the study.”

CardioFocus takes a portfolio approach to PFA—in addition to OptiShot, the company said it will continue trials to evaluate its investigational QuickShot PFA system. QuickShot is a large-area focal ablation catheter that integrates with other navigation technologies.

In the EU, the company said it’s treated more than 6,000 patients with its Centauri PFA system, which leverages a proprietary monopolar waveform with marketed contact-force sensing focal ablation catheters and mapping systems.

At the beginning of 2024, CardioFocus acquired Galvanize Therapeutics’ electrophysiology technology division. Included in the acquisition is the Centauri pulsed electric field generator, which has EU approval and is commercially available in the EU and U.K. The QuickShot catheter ablation system was also part of the deal.