Low Energy Therapy to Convert Ventricular Tachycardias (LEVER)

Boston Scientific

Status and phase: Terminated; Early Phase 1

Conditions: Ventricular Tachycardia

Treatments: Device: LEVER Acute Study System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02891863

91003730

Details and patient eligibility

About

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).

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

Acute Testing

Experimental group

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.

Treatment:

Device: LEVER Acute Study System