Therapy Coil Electrogram Collection Study

Lead Insulation Failure Clinical Trial

— TEC  

Official title:

Therapy Coil Electrogram Collection Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02314598
• Other study ID #: TEC Study
• Status: Terminated
• Start date: January 2015
• Est. completion date: September 14, 2017

Study information

• Verified date: October 2019
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: September 14, 2017
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lead Insulation Failure

Intervention

Other:
• No treatment

Locations

Country	Name	City	State
Slovakia	SUSCCH	Banska Bystrica
Slovakia	NUSCH	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 hours
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	1 month
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	1 month