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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02891863




Registration number
NCT02891863
Ethics application status
Date submitted
29/08/2016
Date registered
8/09/2016
Date last updated
17/07/2017

Titles & IDs
Public title
Low Energy Therapy to Convert Ventricular Tachycardias
Scientific title
Low Energy Therapy Application to Convert Ventricular Tachycardias (LEVER)
Secondary ID [1] 0 0
91003730
Universal Trial Number (UTN)
Trial acronym
LEVER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Tachycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - LEVER Acute Study System

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.


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
7 days post-procedure
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Acute - eg within 5 seconds of test therapy delivery

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT02891863
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kurt Roberts-Thompson, MD
Address 0 0
Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02891863