Cryoablation for Ventricular Tachycardia
(FULCRUM-VT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new system called the Adagio Medical vCLAS Ventricular Ablation System. It is designed to help individuals with a heart rhythm problem known as Sustained Monomorphic Ventricular Tachycardia (SMVT), which can occur due to heart scars. The study aims to determine the safety and effectiveness of this treatment. Individuals who have experienced SMVT episodes despite taking certain heart medications and have an implantable cardioverter defibrillator (ICD) may be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.
What prior data suggests that the Adagio Medical vCLAS Ventricular Ablation System is safe for treating Sustained Monomorphic Ventricular Tachycardia?
Research has shown that the Adagio Medical vCLAS Ventricular Ablation System is generally safe for treating sustained monomorphic ventricular tachycardia (SMVT). In one study, only 2.4% of patients experienced major side effects, indicating that most did not encounter serious problems from the treatment. However, there were a few serious issues, including four deaths during the procedure, with only two directly related to it.
Most patients had positive outcomes, with 84.3% not requiring shocks from their implantable cardioverter-defibrillator (ICD) six months post-procedure. These findings suggest that the treatment is well-tolerated and effective for many individuals.12345Why are researchers excited about this trial?
The Adagio Medical vCLAS Ventricular Ablation System is unique because it uses cryoablation, which involves freezing the heart tissue to treat ventricular tachycardia (VT). Unlike traditional ablation methods that use heat, cryoablation aims to minimize damage to surrounding healthy tissues and potentially decrease the risk of complications. Researchers are excited about this treatment because it promises improved precision and safety in targeting the specific heart areas causing the arrhythmias, making it a promising option for patients with VT.
What evidence suggests that the Adagio Medical vCLAS Ventricular Ablation System is effective for treating Sustained Monomorphic Ventricular Tachycardia?
Research has shown that the Adagio Medical vCLAS Ventricular Ablation System effectively treats sustained monomorphic ventricular tachycardia (SMVT). In one study, 97.4% of patients experienced immediate success, indicating the treatment's immediate effectiveness. During the procedure, 98% of abnormal heart rhythms were stopped. Six months later, 84.3% of patients did not receive any shocks from their implanted heart devices. This evidence suggests that the system is both effective and safe for managing SMVT. Participants in this trial will undergo a cryoablation procedure using the vCLAS Ventricular Ablation System to further assess its effectiveness and safety.12678
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with sustained monomorphic ventricular tachycardia (a specific type of abnormal heart rhythm). Participants should be suitable for ablation treatment and able to follow study procedures. People with conditions that could interfere with the study may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo an ablation procedure using the vCLAS Ventricular Ablation System for SMVT
Immediate Follow-up
Participants are monitored for Major Adverse Events within 7 days following the ablation procedure
Extended Follow-up
Participants are monitored for recurrent sustained MMVT and other safety endpoints
Long-term Follow-up
Participants are monitored for Serious Adverse Events and VT recurrence at 12 months
What Are the Treatments Tested in This Trial?
Interventions
- Adagio Medical vCLAS Ventricular Ablation System
Trial Overview
The study is testing a new procedure called ultra low temperature ablation using the Adagio Medical vCLAS system to treat abnormal heart rhythms by freezing small areas of heart tissue causing the problem.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
all enrolled patients will have a ablation procedure using the vCLAS Ventricular Ablation System (VTS Catheter and Console) for SMVT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adagio Medical
Lead Sponsor
Citations
Ultra-low-temperature cryoablation for ventricular tachycardia ...
This case demonstrated the effectiveness and safety of cryothermal ablation of multiple VTs in a patient with a nonischemic cardiomyopathy and electrical storm, ...
2.
investors.adagiomedical.com
investors.adagiomedical.com/news-releases/news-release-details/adagio-medical-submits-premarket-approval-application-fda-vclasrRelease Details
The trial achieved 97.4% acute clinical success and demonstrated compelling 6-month outcomes, including 84.3% freedom from ICD shock, only 2.4% ...
3.
investors.adagiomedical.com
investors.adagiomedical.com/news-releases/news-release-details/adagio-medical-announces-positive-pivotal-results-vclasrAdagio Medical Announces Positive Pivotal Results for vCLAS ...
Key findings included: 98% non-inducibility of targeted ventricular tachycardias (“VT”) se Events 84% freedom from implantable cardioverter ...
catheter ablation in treatment of cardiac arrhythmias
Adagio Medical VT Cryoablation System with vCLAS™ catheter is CE-Mark approved for the treatment of monomorphic ventricular tachycardia. EXPLORE CLINICAL TRIAL ...
NCT05675865 | Cryoablation for Monomorphic Ventricular ...
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained ...
6.
investors.adagiomedical.com
investors.adagiomedical.com/static-files/94760a47-05fd-450c-a333-319fafedae31Form 8-K for Adagio Medical Holdings INC filed 04/27/2026
Adagio Medical Announces Positive Pivotal Results for vCLAS® Ventricular Ablation System. 84% Freedom From Shock and 59% Freedom from VT ...
7.
medicaleconomics.com
medicaleconomics.com/view/adagio-medical-submits-fda-application-for-ventricular-tachycardia-ablation-systemAdagio Medical submits FDA application for ventricular ...
According to Adagio, the study achieved a 97.4% acute clinical success rate. At six months, 84.3% of patients remained free from implantable ...
8.
aerjournal.com
aerjournal.com/articles/ablation-methods-and-catheter-settings-ventricular-tachycardia-ablation-bench-bedside-0?language_content_entity=enAblation Methods and Catheter Settings for Ventricular ...
Following ablation, 89% of patients achieved non-inducibility of VT and 78% were free from ventricular arrhythmias at 3 months.27
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