NCT02891863

Low Energy Therapy to Convert Ventricular Tachycardias

Low Energy Therapy Application to Convert Ventricular Tachycardias (LEVER)

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	LEVER Acute Study System	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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-09-08
• Last updated: 2017-07-17
• Results posted: 2017-07-17

Locations

1 site across 1 country: Australia