Adagio Medical has announced the completion of enrolment in its Cryocure-VT trialof ultra-low temperature cryoablation for the treatment of monomorphic ventricular tachycardias.
Sixty patients with ischaemic and non-ischaemic cardiomyopathies underwent an endocardial ultra-low temperature cryoablation procedure using Adagio’s vCLAS catheter at nine centers in the European Union and Canada. The results of the trial will be used to support Adagio’s CE mark application for its vCLAS catheter in the second half of 2023.
“For years, with much of the energy in interventional electrophysiology directed towards a larger market of atrial fibrillation treatments, the field of VT ablations, and particularly new catheter technologies, has suffered from underinvestment,” said Petr Neuzil (Na Homolce Hospital, Prague, Czech Republic), the highest European enroller in the trial. “To this day we are forced to use the radiofrequency catheters originally developed and labelled for ablation of atrial arrhythmias in a much more stringent environment of a human ventricle, and in a much sicker patient population.
“The innovative vCLAS catheter is an extension of Adagio’s ultra-low temperature cryoablation platform, shown to be highly effective in the treatment of AF, but has been designed specifically for the treatment of ventricular tachycardias, with a bidirectionally deflectable shaft and 15 mm-long ablation element capable of creating large, transmural lesions, enabling the termination of arrhythmias deep in the myocardium.”
“The initial data from the Cryocure-VT trial published recently in the Journal of American College of Cardiology: EP demonstrated successful and efficient use of ultra-low temperature cryoablation across the range of established ablation strategies in conjunction with multiple commercially available electroanatomic mapping systems, making it an easy drop-in technology for any VT ablation programme,” added Tom De Potter (OLV Hospital Aalst Aalst, Belgium), the lead author of the manuscript.
“While long-term results are still being analysed, acutely, purely endocardial ultra-low temperature cryoablation appears to be quite effective in both ischaemic and non-ischaemic patients, the latter being challenging for current radiofrequency catheters due to mid-myocardial nature of their scars. Bringing Adagio’s ultra-low temperature cryoablation technology into routine clinical practice will accelerate the growth in VT ablation volumes, initially for patients with structural heart disease and eventually in patients with idiopathic ventricular arrhythmias.”
