Ventricular Tachycardia
Conditions
Keywords
Implantable Cardioverter-Defibrillator
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.
Interventions
DEVICELEVER 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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System and Procedure Related Adverse Events | 7 days post-procedure | 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 | Acute - eg within 5 seconds of test therapy delivery | 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Acute Testing |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 9 |
| serious Total, serious adverse events | 3 / 9 |
Outcome results
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.
Time frame: Acute - eg within 5 seconds of test therapy delivery
Population: 6 of 9 subjects had at least one inducible VT, a total of 14 attempts to convert VT with multiple pulses were delivered and none converted the VT in any subject.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Testing | Conversion Efficacy of Low Energy VT Therapies | 0 percentage of VF conversion success |
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.
Time frame: 7 days post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Testing | System and Procedure Related Adverse Events | 5 participants |