Therapy Coil Electrogram Collection Study

Medtronic BRC2 sites in 1 country46 target enrollmentJanuary 2015

ConditionsLead Insulation Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lead Insulation Failure
Sponsor: Medtronic BRC
Enrollment: 46
Locations: 2
Primary Endpoint: Number of Patients With Abnormal Electrograms During a Lead Issue
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

September 14, 2017

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medtronic BRC

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Patients With Abnormal Electrograms During a Lead Issue

Time Frame: 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.