Low Energy Therapy to Convert Ventricular Tachycardias

NCT02891863 | Terminated Early Phase 1 Results

• 1 other identifier: 91003730
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Ventricular Tachycardia

Keywords

Implantable Cardioverter-Defibrillator

Outcome Measures

Primary Outcomes (2)

• 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.

  7 days post-procedure

• 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.

  Acute - eg within 5 seconds of test therapy delivery

Study Arms (1)

Acute Testing

EXPERIMENTAL

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.

Device: LEVER Acute Study System

Interventions

LEVER Acute Study System 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.

Acute Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Royal Adelaide Hospital

Adelaide, Australia

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Greg Voss
• Organization: Boston Scientific CRM

gregory.voss@bsco.com

651-581-3068

Study Officials

• Kurt Roberts-Thompson, MD

  Royal Adelaide Hospital

  PRINCIPAL INVESTIGATOR

• Andreas Bollmann, MD

  Hertz Centrum, Leipzig

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 8, 2016
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 17, 2017
• Results First Posted: July 17, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)