Study to Evaluate Tetanizing Burst Therapy in Patients Undergoing ICD Replacement

EP Sciences

Status

Unknown

Conditions

Cardiac Electrophysiology

Treatments

Device: Tetanizing Burst Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT03628911

TBT001

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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