Low Energy Therapy to Convert Ventricular Tachycardias
Low Energy Therapy to Convert Ventricular Tachycardias
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).
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.
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.