Low Energy Therapy to Convert Ventricular Tachycardias

Early Phase 1

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Acute Testing	LEVER Acute Study System	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.

Primary Outcome Measures

Name	Time	Method
Conversion Efficacy of Low Energy VT Therapies	Acute - eg within 5 seconds of test therapy delivery	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.
System and Procedure Related Adverse Events	7 days post-procedure	All system and procedure-related adverse events through 7 days (-1/+3 days) post-procedure will be collected and tracked.

Secondary Outcome Measures