Adagio Medical Reports Successful Pivotal Outcomes for vCLAS® Ventricular Ablation System
Adagio Medical Holdings, Inc. has reported compelling six-month clinical outcomes from its pivotal FULCRUM-VT Investigational Device Exemption (IDE) trial, marking a significant milestone in the advancement of catheter ablation therapies for ventricular tachycardia (VT). The findings, presented during a late-breaking clinical trial session at the Heart Rhythm Society 2026 meeting, are expected to play a central role in supporting the company’s forthcoming Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) for its vCLAS Ventricular Ablation System.
The FULCRUM-VT study evaluated the safety and effectiveness of Adagio’s proprietary ultra-low temperature cryoablation (ULTA) technology in a population of patients suffering from drug-refractory VT associated with structural heart disease. This includes individuals diagnosed with either ischemic cardiomyopathy (ICM) or non-ischemic cardiomyopathy (NICM), both of which are historically challenging to treat due to differences in arrhythmogenic substrates and disease progression.
At the six-month follow-up, the trial demonstrated a strong combination of procedural success, durable efficacy, and a favorable safety profile. One of the most notable outcomes was the achievement of 98% non-inducibility of targeted VT at the conclusion of the ablation procedure, indicating a high level of immediate procedural effectiveness. This metric is particularly significant, as non-inducibility of arrhythmia is widely regarded as a key procedural endpoint in VT ablation therapies.
In terms of longer-term outcomes, 84% of patients remained free from implantable cardioverter defibrillator (ICD) shocks at six months, highlighting a meaningful reduction in life-disrupting and potentially traumatic device interventions. Additionally, 59% of patients experienced complete freedom from any VT recurrence over the same period. This composite endpoint included episodes of sustained VT lasting more than 30 seconds, ICD shocks, anti-tachycardia pacing (ATP), and escalation of anti-arrhythmic drug (AAD) therapy.
Importantly, the study revealed consistent efficacy across both ICM and NICM patient populations. Historically, NICM patients have presented greater treatment challenges due to deeper myocardial arrhythmogenic substrates that are less accessible with conventional endocardial ablation technologies. However, the vCLAS system demonstrated equivalent outcomes between the two groups, suggesting that ULTA technology may overcome longstanding limitations in treating these complex cases.
Beyond arrhythmia suppression, the trial also demonstrated clinically meaningful improvements in patient management. There was an over 80% reduction in the number of patients experiencing ICD shocks during the six months following ablation compared to the six months prior. Furthermore, 72% of patients were able to either discontinue or reduce their dosage of amiodarone, a commonly used anti-arrhythmic medication associated with significant long-term toxicity risks. This reduction in drug dependence represents an important advancement in improving patient quality of life and minimizing adverse drug effects.
Hospitalization outcomes further underscored the therapy’s potential clinical and economic benefits. The study reported a low 1.9% rate of VT-related hospital readmissions within 30 days, a figure that compares favorably with historical benchmarks in VT ablation literature.
The FULCRUM-VT trial was designed as a prospective, multi-center, open-label, single-arm IDE study conducted across 20 leading centers in the United States and Canada. A total of 209 patients were enrolled, making it one of the largest and most comprehensive VT ablation studies to date. Notably, it is the first fully enrolled IDE trial in this field to include both ischemic and non-ischemic cardiomyopathy patients within a single study framework.
The patient population represented a particularly high-risk cohort, with an average left ventricular ejection fraction (LVEF) of approximately 35% (±10%), 34% diagnosed with NICM, and 79% experiencing congestive heart failure. These characteristics highlight the severity of disease among participants and reinforce the clinical relevance of the observed outcomes.
Additional procedural insights revealed a mean ablation time of 54 minutes per patient, with an average of 11.5 lesions delivered per procedure. These metrics suggest a relatively efficient workflow, particularly when compared to traditional VT ablation techniques, which can be time-intensive and technically demanding.
Safety outcomes from the trial were also encouraging. The overall rate of protocol-defined major adverse events was 2.4%, including four peri-procedural deaths (1.9%). Of these, only two events (1.0%) were adjudicated by an independent Clinical Events Committee as possibly related to the investigational device. All safety and efficacy endpoints were rigorously evaluated by independent committees, adding credibility to the findings.
Commenting on the results, Dr. Atul Verma, Director of the Division of Cardiology at the McGill University Health Centre, emphasized the clinical significance of the trial. He noted that FULCRUM-VT represents a major advancement in VT management, particularly as the first large-scale pivotal study to demonstrate strong outcomes in both ischemic and non-ischemic patient populations. He also highlighted the advantages of the endocardial-only approach enabled by ULTA technology, which eliminates the need for irrigation or adjunctive agents such as nitroglycerin—both of which can introduce additional procedural risks.
Dr. Verma further pointed out that the ability to achieve deep, effective lesions without compromising safety is a key differentiator of the vCLAS system. This is especially important for patients with advanced structural heart disease, where procedural risks are inherently higher.
From a corporate perspective, Todd Usen, Chief Executive Officer of Adagio Medical, described the results as a pivotal milestone for the company. He emphasized that ventricular arrhythmias are responsible for approximately 300,000 sudden cardiac deaths annually in the United States alone, underscoring the urgent need for more effective treatment options. According to Usen, the FULCRUM-VT trial validates the potential of ULTA technology to address this unmet need by delivering both strong efficacy and a highly favorable safety profile.
He also highlighted the procedural advantages of the vCLAS system, including improved catheter stability and the elimination of irrigation requirements, which may simplify workflows and enhance reproducibility across operators and clinical settings.
Adding further perspective, Dr. Matthew Hakimi noted that the FULCRUM-VT results compare favorably with established radiofrequency (RF) ablation benchmarks as well as emerging pulsed field ablation (PFA) technologies. He emphasized that the ability to safely navigate near critical structures, such as coronary arteries, while delivering precise and titratable lesion depths, positions ULTA as a versatile and potentially transformative platform for VT ablation.
In summary, the six-month results from the FULCRUM-VT trial provide robust evidence supporting the safety, efficacy, and clinical utility of Adagio Medical’s vCLAS Ventricular Ablation System. By demonstrating consistent outcomes across diverse and high-risk patient populations, along with meaningful reductions in arrhythmia burden, ICD interventions, medication use, and hospitalizations, the study sets a new benchmark in the evolving field of ventricular arrhythmia treatment. As Adagio moves forward with its FDA submission, these findings may pave the way for broader adoption of ULTA technology and a new standard of care for patients suffering from ventricular tachycardia.
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