Clinical trial NCT02891863: Low Energy Therapy to Convert Ventricular Tachycardias
Official title: Low Energy Therapy Application to Convert Ventricular Tachycardias (LEVER)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Ventricular Tachycardia
Keywords: Implantable Cardioverter-Defibrillator
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: System and Procedure Related Adverse Events
timeFrame: 7 days post-procedure
measure: Conversion Efficacy of Low Energy VT Therapies
timeFrame: Acute - eg within 5 seconds of test therapy delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
Study officials:
affiliation: Royal Adelaide Hospital
name: Kurt Roberts-Thompson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hertz Centrum, Leipzig
name: Andreas Bollmann, MD
role: PRINCIPAL_INVESTIGATOR
References: