Collection of ElectroMagnetic Interference Signals Induced by an Electrosurgery Device in Patients with ICDs or CRT-Ds (Collect EMI Study)

Summary

This acute, non-randomized, multi-center data collection study is designed to collect electromagnetic interference (EMI) signals (electrograms, sense marker and ECG) during electrosurgery when a patient implanted with an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) is under surgery. The data will be used for prototyping an automatic EMI detection algorithm for future ICD or CRT-D devices.
This type of algorithm may significantly reduce service burdens for clinicians and Medtronic, and reduce inappropriate ICD therapies as well. Specifically, electrosurgery noise signals from ICD/CRT-D leads will be recorded in order to investigate feasibility of noise rejection with digital signal processing while maintaining high sensitivity to detect ventricular arrhythmias and also providing adequate backup bradycardiac pacing.

Participant Eligibility

1) Patients already implanted with a market-released Medtronic ICD device (single or dualchamber) or Medtronic CRT-D device with wireless telemetry and any chronic rightventricular (RV) endocardial leads

2) Patients having surgery which requires using a commercial monopolar electrosurgery device (e.g. electrocautery and/or non-cardiac radio frequency ablation surgical tool)

3) Patients who are at least 18 years of age

4) Patients willing and able to give informed consent

Note: Patients undergoing ICD/CRT-D replacements or lead revisions that meet the inclusion
criteria, and none of the exclusion criteria, can be enrolled. Collection of EGM data will
be from the currently implanted, chronic RV leads.