Lead Insulation Failure
Conditions
Brief summary
This is a prospective, non-randomized, multicenter, post market release study which will collect electrograms (EGMs) from patients at risk of a suspected insulation failure to the high voltage portion of the defibrillator lead and will evaluate the electrogram signals.
Interventions
OTHERNo treatment
Sponsors
Medtronic BRC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is willing to sign and date the study Informed Consent form * Subject is at least 18 years of age (or older, if required by local law) * Subject is willing and able to wear a Holter monitor for up to 24 hours * Subject has been implanted with a Medtronic ICD or CRT-D device * Subject has an increased risk of lead insulation breach
Exclusion criteria
* Subject has medical conditions that would limit study participation * Subject is enrolled in one or more concurrent studies that would confound the results of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Abnormal Electrograms During a Lead Issue | 24 hours | Number of patients with at least one instance of abnormal noise during recording. Electrograms will be collected during 24 hours and afterwards abnormalities in the electrograms will be visually identified. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Abnormal Electrograms and Lead Failure | 1 month | Compare the proportion of patients with abnormal electrograms (e.g. high frequency spike) and a high voltage lead failure within 1 month to those patients with abnormal electrograms and no lead failure within 1 month |
| Additional Abnormal Electrogram Characteristics | 1 month | Identify additional characteristics in the Far-field Electrograms that may halp to identify patients at risk of a high voltage lead failure |
Countries
Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead | 46 |
| Total | 46 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 24 Participants | — |
| Age, Categorical Between 18 and 65 years | 22 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Slovakia | 46 participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 40 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Patients With Abnormal Electrograms During a Lead Issue
Number of patients with at least one instance of abnormal noise during recording. Electrograms will be collected during 24 hours and afterwards abnormalities in the electrograms will be visually identified.
Time frame: 24 hours
Population: 46 subjects were enrolled and completed the study. All subjects met the inclusion and exclusion criteria.~5 subjects were excluded since they did not have an Holter recording with at least 12 hours of telemetry.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Participants | Number of Patients With Abnormal Electrograms During a Lead Issue | 0 Participants |
Secondary
Additional Abnormal Electrogram Characteristics
Identify additional characteristics in the Far-field Electrograms that may halp to identify patients at risk of a high voltage lead failure
Time frame: 1 month
Population: There were no patients with a high voltage lead failure, therefore the additional characteristics cannot be identified.
Secondary
Proportion of Patients With Abnormal Electrograms and Lead Failure
Compare the proportion of patients with abnormal electrograms (e.g. high frequency spike) and a high voltage lead failure within 1 month to those patients with abnormal electrograms and no lead failure within 1 month
Time frame: 1 month
Population: There were no patients with a high voltage lead failure, therefore the proportions cannot be estimated nor compared.