Study to Evaluate Tetanizing Burst Therapy in Patients Undergoing ICD Replacement

Status unconfirmed · Not applicable

Conditions studied: Cardiac Electrophysiology

In brief

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

Key facts

Study ID

NCT03628911

Run by

EP Sciences

People needed

50

Starts

2018-01-01

Expected to finish

2020-12-01

Last updated by the study team

2019-09-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.