Low Energy Therapy to Convert Ventricular Tachycardias

Ventricular Tachycardia Clinical Trial

— LEVER  

Official title:

Low Energy Therapy Application to Convert Ventricular Tachycardias (LEVER)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02891863
• Other study ID #: 91003730
• Status: Terminated
• Phase: Phase 0
• First received: August 29, 2016
• Last updated: September 1, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No