Back to resultsLow Energy Therapy to Convert Ventricular Tachycardias (LEVER)
Primary Purpose
Ventricular Tachycardia
Status
Terminated
Phase
Early Phase 1
Locations
Australia
Study Type
Interventional
Intervention
LEVER Acute Study System
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Implantable Cardioverter-Defibrillator
Eligibility Criteria
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.
Sites / Locations
- Royal Adelaide Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acute Testing
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02891863
First Posted
August 29, 2016
Last Updated
April 18, 2017
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02891863
Brief Title
Low Energy Therapy to Convert Ventricular Tachycardias
Acronym
LEVER
Official Title
Low Energy Therapy Application to Convert Ventricular Tachycardias (LEVER)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Implantable Cardioverter-Defibrillator
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acute Testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
LEVER Acute Study System
Intervention Description
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.
Primary Outcome Measure Information:
Title
System and Procedure Related Adverse Events
Description
All system and procedure-related adverse events through 7 days (-1/+3 days) post-procedure will be collected and tracked.
Time Frame
7 days post-procedure
Title
Conversion Efficacy of Low Energy VT Therapies
Description
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.
Time Frame
Acute - eg within 5 seconds of test therapy delivery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Roberts-Thompson, MD
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Bollmann, MD
Organizational Affiliation
Hertz Centrum, Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Acute feasibility study of possible new product feature, confidential information
Learn more about this trial
Low Energy Therapy to Convert Ventricular Tachycardias
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