Therapy Coil Electrogram Collection Study

Medtronic BRC46 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lead Insulation Failure

Interventions

No treatmentOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

SUSCCH

Banská Bystrica, Slovakia

NUSCH

Bratislava, Slovakia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.