Low Energy Therapy to Convert Ventricular Tachycardias (LEVER)

Low Energy Therapy Application to Convert Ventricular Tachycardias (LEVER)

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).

Study Overview

• Status: Terminated
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: LEVER Acute Study System

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Royal Adelaide Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute Testing; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Kurt Roberts-Thompson, MD, Royal Adelaide Hospital; Principal Investigator: Andreas Bollmann, MD, Hertz Centrum, Leipzig

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Implantable Cardioverter-Defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 91003730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Acute feasibility study of possible new product feature, confidential information