An interventional study of Tetanizing Burst Therapy in Cardiac Electrophysiology, sponsored by EP Sciences. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by EP Sciences · Not applicable, Interventional, and Treatment
This study evaluates whether the addition of tetanizing burst therapy reduces the pain associated with ICD shocks
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.
This is the only study on the registry with EP Sciences as lead sponsor.
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Tetanizing Burst Therapy tetanizes skeletal muscle with a brief burst of stimulation prior to ICD shock, thereby reducing muscular contraction due to the shock
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.
Time frame: 5 minutes
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
Time frame: 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.
Time frame: 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
Time frame: 5 minutes
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Sep 2020, 32 months after the start.
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This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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