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Therapy Coil Electrogram Collection Study (TEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02314598
Recruitment Status : Unknown
Verified June 2017 by Medtronic BRC.
Recruitment status was:  Active, not recruiting
First Posted : December 11, 2014
Last Update Posted : June 20, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Lead Insulation Failure Other: No treatment

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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapy Coil Electrogram Collection Study
Actual Study Start Date : January 2015
Estimated Primary Completion Date : September 20, 2017
Estimated Study Completion Date : October 20, 2017

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

Primary Outcome Measures :
  1. Occurrence of abnormal electrograms during a lead issue [ Time Frame: 24 hours ]
    Electrograms will be collected during 24 hours and afterwards abnormalities in the electrograms will be visually identified.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02314598

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Banska Bystrica, Slovakia, 97401
Bratislava, Slovakia, 83348
Sponsors and Collaborators
Medtronic BRC

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Responsible Party: Medtronic BRC Identifier: NCT02314598     History of Changes
Other Study ID Numbers: TEC Study
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017