Lead Insulation FailureTECNCT02314598

Therapy Coil Electrogram Collection Study

An observational study of Lead Insulation Failure, run by Medtronic BRC at 2 sites in Slovakia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lead Insulation Failure
What is being tested?: No treatment
How many people: 46 participants
Where: 2 sitesSlovakia
Study dates: Jan 2015to 14 Sep 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device followed-up at community hospitals

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Slovakia2 sites

SUSCCH
Banská Bystrica, 97401
NUSCH
Bratislava, 83348

Other trials in Slovakia

About this study

Conditions: Lead Insulation Failure
Being tested: No treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No treatmentOther

Study groups in NCT02314598
Study group	Role	What they receive
No treatment		Not described Receives: Other: No treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 hours

Secondary outcomes (2)

Proportion of Patients With Abnormal Electrograms and Lead Failure
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
Measured: 1 month
Additional Abnormal Electrogram Characteristics
Identify additional characteristics in the Far-field Electrograms that may halp to identify patients at risk of a high voltage lead failure
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201514 Sep 2017

First posted11 Dec 2014 (estimated)
Study startJan 2015
Primary completion16 May 2017
Study completion14 Sep 2017

Why it stopped: No chance to meet the foreseen target of patients with study endpoint

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lead Insulation FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02314598
Sponsor's protocol ID: TEC Study
Acronym: TEC
Status last verified: Oct 2019
First submitted: 30 Oct 2014
Last updated: 12 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Therapy Coil Electrogram Collection Study
ClinicalTrials.gov ID: NCT02314598
Acronym / sponsor ID: TEC / TEC Study
Conditions: Lead Insulation Failure
Study type: Observational
Recruitment status: TerminatedReason stopped: No chance to meet the foreseen target of patients with study endpoint
Enrolment: 46 participants (actual)
Lead sponsor: Medtronic BRCIndustry (pharma, biotech, devices)
Study start: Jan 2015 (actual)
Primary completion: 16 May 2017 (actual)
Study completion: 14 Sep 2017 (actual)
First posted: 11 Dec 2014 (estimated)
Results: Posted 12 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
No treatment	–	Other: No treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device followed-up at community hospitals

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No treatment	Other	No treatment

Primary outcome

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.

2 secondary outcomes

Proportion of Patients With Abnormal Electrograms and Lead Failure
Time frame: 1 month
Additional Abnormal Electrogram Characteristics
Time frame: 1 month

Results and safety

Results posted to the registry on 12 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	46	46

Primary outcome: Number of Patients With Abnormal Electrograms During a Lead Issue

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	All Study Participants n = 41
Value	0

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: No adverse event collected in this study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lead Insulation Failure, run by Medtronic BRC at 2 sites in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Abnormal Electrograms During a Lead Issue (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02314598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.