Therapy Coil Electrogram Collection Study (TEC)

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 Overview

• Status: Terminated
• Conditions: Lead Insulation Failure
• Intervention / Treatment: Other: No treatment

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Slovakia
  • Banska Bystrica, Slovakia, 97401
    • SÚSCCH
  • Bratislava, Slovakia, 83348
    • NUSCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device followed-up at community hospitals

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No treatment	Other: No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 month

Collaborators and Investigators

• Sponsor: Medtronic BRC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): May 16, 2017
• Study Completion (Actual): September 14, 2017

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: TEC Study