Study to Evaluate Tetanizing Burst Therapy in Patients Undergoing ICD Replacement
NCT ID: NCT03628911
Last Updated: 2019-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-01-01
2020-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Tetanizing Burst Therapy
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
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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EP Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Ronald Berger, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TBT001
Identifier Type: -
Identifier Source: org_study_id
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