Collect therapy coil electrograms from insulation breaches study
- Conditions
- Implanted defibrillator lead high-voltage insulation breachCirculatory System
- Registration Number
- ISRCTN10583311
- Lead Sponsor
- Medtronic, Inc. (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ead 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 Outcome Measures
Name Time Method There are no secondary outcome measures for this study