What side effects are associated with this type of intervention?

Common treatments for Ventricular Tachycardia include antiarrhythmic medications, catheter ablation, and implantable cardioverter-defibrillators (ICDs). Antiarrhythmic medications can cause side effects such as dizziness, fatigue, and proarrhythmia. Catheter ablation, including cryoablation, may lead to complications like bleeding, infection, damage to blood vessels, and arrhythmia recurrence. Specific to cryoablation, potential side effects include damage to surrounding tissues, phrenic nerve injury, and atrioesophageal fistula. The Adagio VT Cryoablation System trial aims to evaluate the safety and effectiveness of cryoablation in treating sustained monomorphic VT.

What prior FDA approvals exist?

The FDA has approved several treatments for Ventricular Tachycardia (VT), including antiarrhythmic drugs like amiodarone and sotalol, and implantable cardioverter-defibrillators (ICDs) for both primary and secondary prevention of sudden cardiac death. While cryoablation is a newer approach being studied for its efficacy in treating sustained monomorphic VT (SMVT), similar to the Adagio VT Cryoablation System, it is not yet widely established as a standard treatment. Traditional catheter ablation using radiofrequency energy is more commonly used and has been FDA-approved for treating various types of arrhythmias, including VT.

What other types of research exist?

Promising novel alternatives to the Adagio VT Cryoablation System for treating Ventricular Tachycardia in 2024 include: 1) Radiofrequency Ablation (RFA), which uses heat to destroy abnormal tissue and has been widely used with proven efficacy. 2) Stereotactic Body Radiotherapy (SBRT), a non-invasive technique that delivers precise radiation doses to target arrhythmogenic foci. 3) Electroporation-based therapies, such as Pulsed Field Ablation (PFA), which use electrical pulses to selectively ablate cardiac tissue with minimal damage to surrounding structures. 4) Advanced antiarrhythmic drugs, which are continually being developed to manage arrhythmias pharmacologically. These alternatives offer various benefits and should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Cryoablation

Cryoablation for Ventricular Tachycardia (FULCRUM-VT Trial)

N/A

Recruiting

Research Sponsored by Adagio Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Refractory to, or intolerant of, at least one Class III AAD

Subject has LVEF ≥ 20%, confirmed by echo or comparable technique during baseline evaluation or in the previous three months

Must not have

Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure

Idiopathic VT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12-months post cryoablation procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device that uses extreme cold to treat patients with a specific type of irregular heartbeat. It targets patients who have not responded to other treatments by freezing problematic heart tissue to stop abnormal signals.

Who is the study for?

This trial is for adults (18+) with recurrent, symptomatic ventricular tachycardia linked to heart disease who've had an ICD implanted and are unresponsive or intolerant to certain medications. Participants must have a left ventricular ejection fraction of at least 20% and have experienced VT in the past 6 months. Exclusions include allergies to contrast dye, recent heart procedures, pregnancy, other conflicting medical conditions or treatments.

What is being tested?

The study tests the safety and effectiveness of the Adagio VT Cryoablation System for treating Sustained Monomorphic Ventricular Tachycardia (SMVT). It involves using cold temperatures to destroy abnormal heart tissue causing rapid heartbeat.

What are the potential side effects?

Potential side effects may include discomfort at the ablation site, bleeding, blood vessel damage, arrhythmias during procedure recovery, reactions to contrast dye used during imaging if not managed properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a bad reaction or no response to a specific heart medication.

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My heart's pumping ability is at least 20%.

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I have had at least one spontaneous blood clot in my veins in the last 6 months.

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I need a procedure to correct heart rhythm problems due to heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a stroke, mini-stroke, or blood clot (except DVT after surgery) in the last 6 months.

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I have ventricular tachycardia with no known cause.

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I am allergic to contrast dye and it can't be managed medically.

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I do not have any current infections or serious illnesses.

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I cannot take heparin due to health reasons.

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I have a history of blood clotting or bleeding disorders.

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I have a history of cryoglobulinemia.

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I have a blood vessel condition that prevents access to my left ventricle.

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I have serious heart conditions or recent heart procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12-months post cryoablation procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12-months post cryoablation procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12-months post cryoablation procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Endpoint for Pivotal Phase

Primary Procedural Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with non-inducible VT or no further ablation targets meeting the criteria for ablation at the end of the cryoablation procedure.

Primary Safety Endpoint for EFS and Pivotal phases is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation procedure.

Secondary study objectives

Health Outcomes for EFS and Pivotal phases are defined as all-cause mortality at 12 months

Health Outcomes for EFS and Pivotal phases are defined as cardiac mortality at 12 months

Health Outcomes for EFS and Pivotal phases are defined as quality-of-life improvement as measured by reduction of VT burden at 6 and 12 months compared to baseline.

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: VT CryoablationExperimental Treatment1 Intervention

all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for SMVT

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ventricular Tachycardia (VT) include antiarrhythmic drugs, catheter ablation, and implantable cardioverter-defibrillators (ICDs). Antiarrhythmic drugs work by altering the electrical signals in the heart to prevent abnormal rhythms. Catheter ablation, including cryoablation, targets and destroys the abnormal heart tissue causing the arrhythmia. Cryoablation specifically uses extreme cold to create scar tissue, which interrupts the errant electrical pathways. Understanding these mechanisms is crucial for VT patients as it helps in selecting the most effective treatment, minimizing symptoms, and reducing the risk of sudden cardiac events.