Adagio Medical’s FULCRUM‑VT Trial Delivers Strong Six‑Month VT Outcomes

Adagio Medical (NASDAQ: ADGM) reported positive six‑month results from its pivotal FULCRUM‑VT trial evaluating the vCLAS ventricular ablation system in patients with drug‑refractory ventricular tachycardia (VT). The open‑label, multi‑centre, single‑arm trial achieved 98% non‑inducibility of targeted VTs at the end of the procedure and a 2.4% rate of protocol‑defined major adverse events, suggesting a promising safety and effectiveness profile.

Shock reduction and VT recurrence

At six months, 84% of patients were free from implantable cardioverter‑defibrillator (ICD) shocks, and 59% had no VT recurrence, a composite measure that also accounts for anti‑arrhythmic drug escalation and antitachycardia pacing. The data showed more than an 80% reduction in the proportion of patients experiencing ICD shocks compared with the six months before ablation, pointing to a meaningful reduction in arrhythmia burden.

Consistent results across patient types

Outcomes were comparable in patients with both ischemic and non‑ischemic cardiomyopathy, with freedom from ICD shocks at six months around the mid‑80% range in each group. Investigators highlighted that this is one of the more challenging VT populations studied to date, making the consistency of results across structural heart‑disease subtypes clinically notable.

Medication use, readmissions, and procedure metrics

By six months, 72% of trial participants were able to reduce or discontinue amiodarone, indicating potential to lessen reliance on this commonly used but side‑effect‑prone anti‑arrhythmic. The study reported a low 1.9% 30‑day VT‑related hospital readmission rate, and mean ablation time was about 54 minutes per patient with an average of 11.5 lesions, underscoring procedural efficiency for this ultra‑low‑temperature ablation approach.

Regulatory and commercial implications

The FULCRUM‑VT results are intended to support a premarket approval (PMA) submission to the U.S. FDA for the vCLAS ventricular ablation system. Clinical experts and company leadership note that the outcomes compare favorably with published radiofrequency and emerging pulsed field ablation data, positioning Adagio’s ULTA technology as a potential new option in VT ablation if regulators ultimately grant approval.