Adagio Medical ULTC Feasibility Study Shows 92.9% Non-Inducibility and No Major AEs
Adagio Medical’s ULTC feasibility study of 20 ventricular tachycardia patients at four U.S. centers reported no major adverse events at 7 or 30 days and achieved 92.9% arrhythmia non-inducibility. At 24 weeks, 72% reduced or stopped antiarrhythmics and 83.3% remained free of ICD shocks.
1. Study Overview
The multicenter early feasibility study enrolled 20 patients with ischemic and non–ischemic cardiomyopathy at four U.S. centers to evaluate ultralow temperature cardiac ablation under the FDA’s Early Feasibility Study framework, focusing on acute safety and performance.
2. Efficacy Outcomes
The study reported no major adverse events at 7 or 30 days, achieved 92.9% non-inducibility of targeted arrhythmias after ablation, and at 24 weeks saw 72% of patients reduce or discontinue antiarrhythmic medications and 83.3% remain free from implantable cardioverter-defibrillator shocks.
3. Future Directions
Following these favorable safety and performance data, Adagio Medical plans to initiate pivotal trials to seek full FDA approval and explore broader clinical applications of ULTC technology for treating scar-related ventricular tachycardia in challenging patient populations.