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Low Energy Therapy to Convert Ventricular Tachycardias

NCT02891863 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-07-17

Study results available
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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).

Conditions

  • Ventricular Tachycardia

Interventions

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Kurt Roberts-Thompson, MD · Royal Adelaide Hospital

  • Andreas Bollmann, MD · Hertz Centrum, Leipzig

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02891863 on ClinicalTrials.gov