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
1 other identifier
interventional
50
1 country
1
Brief Summary
This study evaluates whether the addition of tetanizing burst therapy reduces the pain associated with ICD shocks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedSeptember 17, 2019
September 1, 2019
2.7 years
July 31, 2018
September 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
The efficacy of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by NRS verbal score
5 minutes
The safety of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by adverse events
7 days
The device performance of tetanizing burst therapy in subjects undergoing ICD replacement as assessed degree of muscle contraction (Rate of Force Development)
5 minutes
Interventions
Tetanizing Burst Therapy tetanizes skeletal muscle with a brief burst of stimulation prior to ICD shock, thereby reducing muscular contraction due to the shock
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EP Scienceslead
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Berger, MD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2018
First Posted
August 14, 2018
Study Start
January 1, 2018
Primary Completion
September 1, 2020
Study Completion
December 1, 2020
Last Updated
September 17, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share