Low Energy Therapy to Convert Ventricular Tachycardias

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

LEAP 2 Chronic EFS

NCT07287423

Cardiac Pacemaker Cardiac Rhythm Disorder Bradycardia

RECRUITING NA

Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia

NCT02130765

Monomorphic Ventricular Tachycardia

TERMINATED NA

MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure

NCT00262119

Atrial Fibrillation Heart Failure, Congestive

COMPLETED PHASE4

LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy

NCT05910866

Bradycardia Heart Failure Pacemaker-Induced Cardiomyopathy +2 more

RECRUITING NA

Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) With Omnipolar Mapping Technology

NCT06701292

Atrial Fibrillation

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventricular Tachycardia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

LEVER Acute Study System

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No