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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02891863
Ethics application status
Date submitted
29/08/2016
Date registered
8/09/2016

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
Timepoint [1] 0 0
7 days post-procedure
Primary outcome [2] 0 0
Conversion Efficacy of Low Energy VT Therapies
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
Sex
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
NA
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
9
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Acute feasibility study of possible new product feature, confidential information


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02891863