Study: Ultra-Low Cryoablation Tech Effectively Treats Ventricular Tachycardia

Adagio Medical Holdings Inc. is sharing encouraging preliminary acute (within seven days) safety and efficacy results from its FULCRUM-VT Study evaluating Ultralow Temperature Cryoablation (ULTC) for treating sustained monomorphic ventricular tachycardia (SMVT) in patients with both ischemic and nonischemic cardiomyopathy.

A total of 207 patients underwent ventricular tachycardia (VT) ablation using Adagio’s ULTC system at 19 U.S. and Canadian sites. The study included patients with both ischemic and non-ischemic cardiomyopathies (LVEF=35+/-10%, 33% NICM, 75% with congestive heart failure). Mean procedure duration was 206+/- 68 minutes and acute clinical success, defined as non-inducibility of target ventricular arrhythmias, was 97.4%, with all clinically-relevant ventricular tachycardias eliminated in 96.7% of patients tested by post-ablation programmed electrical stimulation. Key safety findings included a 2.5% rate of major adverse events including four (1.9%) peri-procedural deaths, of which one (0.5%) was adjudicated by an independent clinical events committee as definitely related to the investigational device.

“The patient profile in FULCRUM-VT is representative of what we see in real-world practice. The ability of Adagio’s ULTC system to produce deep, titratable endocardial lesions without irrigation and without concerns for catheter stability make it a promising tool for a broad patient population. These factors, along with the broad inclusion criteria for the study, fueled swift enrollment,” said Travis Richardson, M.D., assistant professor of Medicine, Clinical Cardiac Electrophysiology, at Vanderbilt University Medical Center. “FULCRUM-VT not only included patients with ischemic myopathy, but also a large number with nonischemic disease, whose VT is often more difficult to treat due to deep substrate. Despite this, the acute effectiveness across the study population was excellent. This, along with the favorable safety profile of the ULTC System, is encouraging. VT is a largely undertreated condition, partially because the available treatment tools make ablation procedures challenging, and I have hope that ULTC will help to change that. We look forward to the six-month primary efficacy endpoint results of the FULCRUM-VT trial, which the company currently plans to share at the Heart Rhythm 2026 conference.”

The FULCRUM-VT Study is a prospective, multi-center ULTC investigation evaluating acute safety and effectiveness in patients with scar-related VT refractory to antiarrhythmic drug therapy and a left ventricular ejection fraction greater than 20%. Long-term outcomes as well as analysis of the effectiveness in different myocardial substrates will be reported in the future. Study results will be used to apply for U.S. Food and Drug Administration premarket approval (PMA) for Adagio’s vCLAS Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT.

“We are pleased with the preliminary FULCRUM-VT acute data, which highlight the potential of Adagio’s proprietary ULTC technology to transform treatment for patients with ventricular tachycardia,” Adagio Medical CEO Todd Usen stated. “On behalf of the entire Adagio Medical team, I want to thank all of the investigators, research coordinators and patients who have supported this study and whose commitment to serving this underserved population of patients will bring us one step closer to a purpose-built solution for VT.”

Adagio is a medical device company developing and commercializing products to treat cardiac arrhythmias using its proprietary, catheter-based ULTC technology. ULTC is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue. The company is currently focused on treating ventricular tachycardia with its purpose-built, CE Marked vCLAS Cryoablation System. The vCLAS Cryoablation System is commercially available to treat monomorphic ventricular tachycardia in Europe and select other geographies but is limited to investigational use in the United States.