Therapy Coil Electrogram Collection Study

Terminated

• Conditions: Lead Insulation Failure

• Registration Number: NCT02314598
• Lead Sponsor: Medtronic BRC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-11
• Study Start: 2015-01
• Primary Completion: 2017-05-16
• Study Completion: 2017-09-14
• Results First Submitted: 2018-06-20
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-21
• Last Update Submitted: 2019-10-21
• Results First Posted: 2019-11-12
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

SUSCCH; 🇸🇰 Banska Bystrica, Slovakia

NUSCH; 🇸🇰 Bratislava, Slovakia