Adagio Medical has announced successful first-in-human use of ultra-low temperature cryoablation (ULTC) for the treatment of monomorphic ventricular tachycardia (VT).
The two-hour mapping and ablation procedure was performed by Tom De Potter, associate director, Cardiovascular Center Department of Cardiology, Electrophysiology Section at the Cardiovascular Center OLV Hospital, Aalst, Belgium. Procedural success was ascertained by the lack of the inducible arrhythmia after a set of ULTC lesions was delivered to isolate inferior-posterior ischaemic scar in the patient’s left ventricle. No procedural complications were observed, and the patient remained arrhythmia-free through the first 30 days of the follow-up.
“This first procedure marks the beginning of a prospective, multicentre study for Adagio’s VT Cryoablation System, which will support future CE mark submission,” said Olav Bergheim, president and CEO of Adagio. “The system leverages our unique iCLAS platform technology for the ablation of atrial arrhythmias which is commercially available in Europe and is undergoing US Food and Drug Administration (FDA) IDE trial in the USA. The VT catheter is designed to meet stringent anatomic and physiologic requirements of ventricular ablations.”
VT and ventricular fibrillation are important causes of sudden cardiac death, accounting for as many as 450,000 annual deaths in the USA alone. Implantable cardiac defibrillators reduce the incidence of death in patients with arrhythmias, but are not curative, and can contribute to reduced quality of life in patients with recurring episodes.
“Catheter ablations for the treatment of ventricular tachycardia have been proven effective in preventing recurring arrhythmias in cardiomyopathy patients who are refractory to the anti-arrhythmic drug therapy,” commented De Potter. “These ablation procedures can be very technical, and current energy sources are often insufficient to terminate arrhythmia circuits beyond subendocardial surface.”
“The unique advantage of Adagio’s ultra-low temperature cryoablation is its ability to create fully transmural, contiguous lesions through thick ventricular tissue,” added Lucas Boersma at St Antonius Hospital Nieuwegein and professor at Amsterdam UMC , a study investigator and a pioneer of ULTC technology. “If proven safe and effective, this feature of ULTC will undoubtedly make it a go-to tool for any centre performing VT interventions.”
Adagio Medical VT Cryoablation study will enroll up to 40 patients with monomorphic VT of both ischaemic and non-ischaemic origin at six academic medical centres in Europe and Canada. To date, this is the only registered study designed to evaluate acute and long-term safety and effectiveness of cryoablation in VT patients.