Galaxy Medical, a developer of pulsed electric field (PEF) technology, has announced that the first patients in the ECLIPSE-AF study were successfully treated with the proprietary Centauri system by Ante Anić in Split, Croatia. The multicentre trial is designed to assess the safety and efficacy of the Centauri system and is intended to support CE mark approval.
The Centauri system is designed as an open energy platform with proprietary interface hardware and waveform control algorithms, which enable electrophysiologists to continue with the established point-by-point clinical workflow used in the majority of cardiac ablation procedures.
Ante Anić, EP lab director at University Hospital Split, Split, Croatia and the primary investigator of the ECLIPSE-AF study, said: “The Galaxy Medical Centauri System operated seamlessly within my atrial fibrillation ablation clinical workflow. Pulsed electric field energy is the future of EP and Centauri allowed me to deliver it with a standard focal ablation technique to patients under conscious sedation, and without compromising on the ablation catheter, contact force feedback, or cardiac mapping system.”
PEF technology utilises high voltage, high frequency bursts of electrosurgical energy to ablate tissue. This has the potential to improve the safety of cardiac ablation by reducing the unintentional conductive heating or cooling of extracardiac structures including the oesophagus, phrenic nerve, and airway. Efficacy may be enhanced with the creation of full-thickness, transmural lesions where the therapeutic dose of PEF energy is limited to the myocardium.
Jonathan Waldstreicher, CEO of Galaxy Medical commented: “In developing the Centauri System, our three main priorities are safety, interoperability, and efficacy. With the complete elimination of microbubbles, which may cause cerebral or coronary air emboli, we have addressed the primary safety concern with PEF technology in the heart. On interoperability, we integrate into today’s EP lab with the tools that electrophysiologists have come to depend on to deliver safe and effective patient-centred ablation procedures tailored to each patient’s unique anatomy, which will lead to more rapid uptake of this technology. And on efficacy, our research has consistently demonstrated that PEF with focal catheters yields predictable and transmural lesions as opposed to inconsistent ablation depth and intermittent electrical stunning associated with multipolar catheters with variable contact. We look forward to completing enrollment of the ECLIPSE-AF study and sharing the clinical experience in the near future.”
As part of the ECLIPSE-AF study, patients will be assessed and followed with extensive safety and efficacy procedures including acute demonstration of entrance and exit block, monitoring of acute ST-segment changes, assessment of microbubbles on intracardiac echocardiography, assessment of pulmonary vein anatomy, three-month electrophysiologic remapping to confirm durability of pulmonary vein isolation, Holter monitoring at long term follow-up, cerebral MRI and upper GI endoscopy.
The Centauri System is an investigational device and not approved for commercial use.