Study to Evaluate Tetanizing Burst Therapy in Patients Undergoing ICD Replacement

Evaluation of the Ongoing Safety and Preliminary Efficacy of the Tetanizing Burst Therapy (TBT) System in Subjects Undergoing ICD Replacement Due to End-of-battery Life

This study evaluates whether the addition of tetanizing burst therapy reduces the pain associated with ICD shocks

Study Overview

• Status: Unknown
• Conditions: Cardiac Electrophysiology
• Intervention / Treatment: Device: Tetanizing Burst Therapy

Detailed Description

The implantable cardioverter defibrillator is a device designed to rescue patients from life-threatening arrhythmias by delivering a defibrillation shock to allow restoration of cardiac rhythm. These defibrillation shocks are extremely painful, owing to sudden rapid contraction of thoracic and abdominal skeletal muscle, which, in addition to the heart, are stimulated by the defibrillation shock. Tetanizing Burst Therapy is a novel electrical waveform which tetanizes skeletal muscle with a brief burst of stimulation prior to the ICD shock, thereby reducing muscular contraction due to the shock. This study is designed for those patients who are already undergoing ICD replacement.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jane Wilson; Phone Number: 8457218210; Email: janew@databean.com

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Michele Martucci, RN; Phone Number: 410-502-0517; Email: mmill148@jhmi.edu
      • Contact: Kathy Avara; Phone Number: 410-502-5616; Email: kavara1@jhmi.edu
      • Principal Investigator: Ronald Berger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female age 18-80 years, inclusive
• Ability to understand and provide written informed consent
• Normal sinus rhythm
• Standard transvenous left-sided ICD referred for device replacement due to end of battery life

Exclusion Criteria:

• Heart rate <40 or >90 bpm
• Atrial fibrillation or pacemaker dependent
• NYHA Class III/IV symptoms of HF
• MI within 90 days of enrollment
• Severe cardiac ischemia manifested by chest pain at rest or with minimal exercise
• History stroke or TIAs
• History of prior ICD pocket infection
• ICD lead resistance that is too high or too low in the opinion of the investigator
• Female who is pregnant or breastfeeding
• Prior heart transplant
• Serum electrolytes out of normal range at participating institution

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Less pain after TBT impulse with ICD shock compared to ICD shock alone	Each subject will receive 2 therapies in random order delivered 5 minutes apart: Tetanizing Burst Therapy + shock; and; Pure shock alone. Using the Numeric Pain Rating Scale (NRS) after each shock, the subject will be asked to provide a verbal score between 1 and 10, where 1 is no pain and 10 is the worst pain imaginable.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by NRS verbal score	After each shock, a blinded assessor will ask the subject to provide an NRS verbal score between 1 and 10, where 1 is no pain and 10 is the worst pain imaginable. The percent change in the NRS score will be calculated for each subject along with the change in skeletal muscle force waveform	5 minutes
The safety of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by adverse events	Incidence rates of all adverse events will be calculated and compared to event rates in the literature. They will also be analyzed by severity and relationship to the device and/or study procedures.	7 days
The device performance of tetanizing burst therapy in subjects undergoing ICD replacement as assessed degree of muscle contraction (Rate of Force Development)	The force of contraction is recorded at the patient's left elbow with a myometer	5 minutes

Collaborators and Investigators

• Sponsor: EP Sciences
• Investigators: Principal Investigator: Ronald Berger, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: TBT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes