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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 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC

Tracking Information
First Submitted Date October 30, 2014
First Posted Date December 11, 2014
Results First Submitted Date June 20, 2018
Results First Posted Date November 12, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date January 2015
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2019)
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.
Original Primary Outcome Measures
 (submitted: December 8, 2014)
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.
Change History
Current Secondary Outcome Measures
 (submitted: October 21, 2019)
  • 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
  • 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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Therapy Coil Electrogram Collection Study
Official Title Therapy Coil Electrogram Collection Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Lead Insulation Failure
Intervention Other: No treatment
Study Groups/Cohorts No treatment
Intervention: Other: No treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 19, 2017)
46
Original Estimated Enrollment
 (submitted: December 8, 2014)
50
Actual Study Completion Date September 14, 2017
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number NCT02314598
Other Study ID Numbers TEC Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic BRC
Study Sponsor Medtronic BRC
Collaborators Not Provided
Investigators Not Provided
PRS Account Medtronic BRC
Verification Date October 2019