Novel Ablation Technology Reduces Ventricular Tachycardia Recurrence

Current ablation procedures can be complex and may yield suboptimal safety and effectiveness, underscoring the need for a purpose-built ventricular therapy. Hospitals also seek options that enable durable lesions through an endocardial-only approach without added procedural risks. A new ventricular ablation system now reports pivotal six-month outcomes that meet predefined safety and effectiveness endpoints and suggest consistent performance across ischemic and non-ischemic cardiomyopathy.

Adagio Medical’s vCLAS Ventricular Ablation System reported six-month outcomes from the FULCRUM‑VT Investigational Device Exemption (IDE) trial designed for patients with drug‑refractory ventricular tachycardia (VT). The analysis met prespecified safety and effectiveness endpoints, including 84% freedom from implantable cardioverter defibrillator (ICD) shock and 59% freedom from any VT recurrence at six months. Targeted VT non‑inducibility at the end of the procedure was 98%, replicating results seen previously with CryoCure‑VT.

The system employs catheter‑based Ultra‑Low Temperature Ablation (ULTA) to create large, durable lesions that extend through diseased and healthy myocardium via an endocardial‑only approach. ULTA is intended to deliver effective lesion formation without the adjuncts commonly used with other energy sources. The platform is purpose‑built for ventricular substrates encountered in both ischemic and non‑ischemic disease.

The company stated that these six‑month data will be used to support a U.S. Food and Drug Administration (FDA) premarket approval application for vCLAS; the results have not yet been reviewed or approved by the agency. The system is CE Marked and available for treatment of monomorphic VT in select geographies, and it remains investigational in the United States. FULCRUM‑VT is a prospective, multicenter, open‑label, single‑arm IDE study conducted at 20 centers in the U.S. and Canada, enrolling 209 patients with structural heart disease, including both ischemic cardiomyopathy (ICM) and non‑ischemic cardiomyopathy (NICM).

Key outcomes included a 2.4% rate of protocol‑defined major adverse events, with four peri‑procedural deaths (1.9%), two of which (1.0%) were adjudicated as possibly device‑related by an independent committee. Freedom from device intervention (anti‑tachycardia pacing or shock) at six months was 61% for ICM and 63% for NICM, with freedom from ICD shock of 84% and 85%, respectively. Any VT recurrence at six months was defined to include monitor‑zone VT longer than 30 seconds, ICD shock, anti‑tachycardia pacing, or antiarrhythmic drug escalation. 

Additional findings included more than an 80% reduction in the number of patients experiencing ICD shock versus the equivalent pre‑ablation period, 72% of patients discontinuing or reducing amiodarone at six months, a 1.9% 30‑day VT‑related readmission rate, a mean ablation time of 54 minutes, and a mean of 11.5 ± 6 lesions per patient. All safety and recurrence data were independently adjudicated.

"FULCRUM-VT represents a seminal step forward in advancing ventricular tachycardia management by delivering positive, clinically meaningful results from the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic structural heart disease. Importantly, the study further highlights the potential of an endocardial-only approach using Adagio’s purpose-built ventricular ablation technology,” said Dr. Atul Verma, Director, Division of Cardiology, McGill University Health Centre in Montreal. 

“The results of the trial, which were consistent with earlier ULTA studies, combined an excellent safety profile with impressive clinical effectiveness, including reductions in both ICD shocks and the use of toxic antiarrhythmic medication – outcomes that matter most to patients and physicians managing this complex disease. Additionally, the ability to ablate these already compromised patients without ever needing to irrigate or use nitroglycerin, both of which carry added risk, is a real benefit of ULTA. The FULCRUM-VT results are quite encouraging for the broad use of this technology as a long-term solution for patients suffering from VT," said Dr. Verma.

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