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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Lead Insulation Failure
Intervention Other: No treatment
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead
Period Title: Overall Study
Started 46
Completed 46
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
  47.8%
>=65 years
24
  52.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
6
  13.0%
Male
40
  87.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Slovakia Number Analyzed 46 participants
46
1.Primary Outcome
Title Number of Patients With Abnormal Electrograms During a Lead Issue
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description

46 subjects were enrolled and completed the study. All subjects met the inclusion and exclusion criteria.

5 subjects were excluded since they did not have an Holter recording with at least 12 hours of telemetry.

Arm/Group Title All Study Participants
Hide Arm/Group Description:
Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead
Overall Number of Participants Analyzed 41
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Proportion of Patients With Abnormal Electrograms and Lead Failure
Hide Description 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
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
There were no patients with a high voltage lead failure, therefore the proportions cannot be estimated nor compared.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Additional Abnormal Electrogram Characteristics
Hide Description Identify additional characteristics in the Far-field Electrograms that may halp to identify patients at risk of a high voltage lead failure
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
There were no patients with a high voltage lead failure, therefore the additional characteristics cannot be identified.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame No adverse event collected in this study
Adverse Event Reporting Description All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
 
Arm/Group Title All Study Participants
Hide Arm/Group Description Patients at risk of suspected insulation failure to the high voltage portion of the defibrillator lead
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   0/0 

41 out of the 46 enrolled subjects completed a Holter recording with at least 12 hours of telemetry, but none of them reached any study endpoint.

Therefore enrollment and study were closed and foreseen analyses could have not been performed

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ilaria Marcotullio
Organization: Medtronic
Phone: +39 06 32814218
EMail: ilaria.marcotullio@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT02314598    
Other Study ID Numbers: TEC Study
First Submitted: October 30, 2014
First Posted: December 11, 2014
Results First Submitted: June 20, 2018
Results First Posted: November 12, 2019
Last Update Posted: November 12, 2019