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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.
 
ClinicalTrials.gov Identifier: NCT02314598
Recruitment Status : Terminated (No chance to meet the foreseen target of patients with study endpoint)
First Posted : December 11, 2014
Results First Posted : November 11, 2019
Last Update Posted : November 11, 2019
Sponsor:
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
Actual Primary Completion Date : May 16, 2017
Actual Study Completion Date : September 14, 2017

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



Primary Outcome Measures :
  1. Number of Patients With Abnormal Electrograms During a Lead Issue [ Time Frame: 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 :
  1. Proportion of Patients With Abnormal Electrograms and Lead Failure [ Time Frame: 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

  2. Additional Abnormal Electrogram Characteristics [ Time Frame: 1 month ]
    Identify additional characteristics in the Far-field Electrograms that may halp to identify patients at risk of a high voltage lead failure



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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02314598


Locations
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Slovakia
SUSCCH
Banska Bystrica, Slovakia, 97401
NUSCH
Bratislava, Slovakia, 83348
Sponsors and Collaborators
Medtronic BRC
  Study Documents (Full-Text)

Documents provided by Medtronic BRC:
Study Protocol  [PDF] August 27, 2014
Statistical Analysis Plan  [PDF] March 13, 2017


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Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT02314598     History of Changes
Other Study ID Numbers: TEC Study
First Posted: December 11, 2014    Key Record Dates
Results First Posted: November 11, 2019
Last Update Posted: November 11, 2019
Last Verified: October 2019