Low Energy Therapy to Convert Ventricular Tachycardias

Study Overview
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Brief Summary
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The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility study that will assess and characterize early safety and effectiveness of low energy therapies in converting monomorphic ventricular tachycardias (MVTs).

Detailed Description
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The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility study that will assess and characterize early safety and effectiveness of low energy therapies in converting monomorphic ventricular tachycardias (MVTs). Subjects must be already indicated for standard of care VT procedure during which VT is likely to be induced (such as VT testing, VT ablation, VT mapping, or VT risk stratification testing.) The study patches will be applied to the subject's torso, and the patches will be connected to the LEVER Acute Study System. Pacing capture threshold capture may be assessed. If monomorphic VT is induced and reaches at least 170bpm (350ms/cycle), one or more of the low energy therapies will be applied under oversight of the investigator, in an attempt to treat and convert the VT.

Official Title
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Low Energy Therapy Application to Convert Ventricular Tachycardias (LEVER)

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: LEVER Acute Study System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a history of ventricular tachycardia indicated for ventricular testing procedures that may include VT induction, such as VT testing, VT ablation, VT mapping, or VT risk stratification testing. Subjects age 18 or above, or of legal age to give written informed consent specific to local laws and requirements Subjects who, in the opinion of the investigator, are suitable to be enrolled in a clinical study Exclusion Criteria: Subjects with any comorbidities that, in the opinion of the investigator, would exclude them from standard of care VT testing Subjects with VT that is known to be focal in nature Subjects whom the investigator believes are not hemodynamically stable enough to tolerate testing Subjects of childbearing age who may be pregnant. Subjects who are unwilling or unable to provide written informed consent. Subjects with any implanted device that emits electrical energy where either therapy cannot be temporarily disabled, or the subject cannot tolerate temporary disabling of therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute Testing<br>Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System. | Device: LEVER Acute Study System<br>* The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System and Procedure Related Adverse Events | All system and procedure-related adverse events through 7 days (-1/+3 days) post-procedure will be collected and tracked. | 7 days post-procedure | 
| Conversion Efficacy of Low Energy VT Therapies | Effectiveness of LEVER Acute Study System low energy therapies to convert MVTs will be collected and tracked as an aggregate success rate (%) on a per-attempt basis for each therapy tested. | Acute - eg within 5 seconds of test therapy delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable Cardioverter-Defibrillator