Study Stopped
No chance to meet the foreseen target of patients with study endpoint
Therapy Coil Electrogram Collection Study
TEC
1 other identifier
observational
46
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2015
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
December 11, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2017
CompletedResults Posted
Study results publicly available
November 12, 2019
CompletedNovember 12, 2019
October 1, 2019
2.4 years
October 30, 2014
June 20, 2018
October 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With Abnormal Electrograms During a Lead Issue
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.
24 hours
Secondary Outcomes (2)
Proportion of Patients With Abnormal Electrograms and Lead Failure
1 month
Additional Abnormal Electrogram Characteristics
1 month
Study Arms (1)
No treatment
Interventions
Eligibility Criteria
Patients with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device followed-up at community hospitals
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic BRClead
Study Sites (2)
SUSCCH
Banská Bystrica, 97401, Slovakia
NUSCH
Bratislava, 83348, Slovakia
Limitations and Caveats
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
Results Point of Contact
- Title
- Ilaria Marcotullio
- Organization
- Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2014
First Posted
December 11, 2014
Study Start
January 1, 2015
Primary Completion
May 16, 2017
Study Completion
September 14, 2017
Last Updated
November 12, 2019
Results First Posted
November 12, 2019
Record last verified: 2019-10