NCT03628911

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: EP Sciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Electrophysiology

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2018-08-14
• Last updated: 2019-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study