Study to Evaluate Tetanizing Burst Therapy in Patients Undergoing ICD Replacement

Not Applicable

• Conditions: Cardiac Electrophysiology

• Registration Number: NCT03628911
• Lead Sponsor: EP Sciences

Brief Summary

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

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-14
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Less pain after TBT impulse with ICD shock compared to ICD shock alone	5 minutes	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.

Secondary Outcome Measures

Name	Time	Method
The device performance of tetanizing burst therapy in subjects undergoing ICD replacement as assessed degree of muscle contraction (Rate of Force Development)	5 minutes	The force of contraction is recorded at the patient's left elbow with a myometer
The safety of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by adverse events	7 days	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.
The efficacy of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by NRS verbal score	5 minutes	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

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States