Implanted defibrillator lead high-voltage insulation breach Circulatory System
Conditions
Interventions
Study subjects will wear a telemetry Holter monitor that stores continuous implanted device data for up to 24 hours. The study will be reviewing electrogram (EGM) data collected by the Holter monitor
Sponsors
Medtronic, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject (or subject’s legally authorized representative) is willing and able to provide written informed consent 2. Subject is at least 18 years of age (or older, if required by local law) 3. Subject is willing and able to wear a Holter monitor for at least 2 hours and up to 24 hours 4. Subject has been implanted with a Medtronic ICD or CRT-D device 5. Subject’s defibrillator lead has a possible high voltage insulation breach, as suggested by device diagnostics exhibiting any of the following three characteristics: 5.1. Abrupt high voltage impedance decrease (25% decrease in daily impedance from baseline) 5.2. Non-physiologic noise on high voltage EGM 5.3. Less than 50% programmed shock energy delivered
Exclusion criteria
Exclusion criteria: 1. Subject has medical conditions that would limit study participation (per physician discretion) 2. Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by Medtronic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lead insulation breaches in the high-voltage portion of defibrillation leads, measured using EGM data at any time between the end of Holter monitor use to up to 180 days post-Holter use | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures for this study | — |
Countries
United States of America
Outcome results
None listed