Therapy Coil Electrogram Collection Study (TEC)

Medtronic

Status

Terminated

Conditions

Lead Insulation Failure

Treatments

Other: No treatment

Study type

Observational

Funder types

Industry

Identifiers

NCT02314598

TEC Study

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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