Condition category
Circulatory System
Date applied
28/07/2016
Date assigned
17/08/2016
Last edited
08/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
An implantable cardioverter defibrillator (ICD) is a small device that is used to treat people with dangerously abnormal heart rhythms. An ICD can give the heart electric pulses or shocks to get the heart rhythm back to normal. The ICD is inserted just under the collar bone and is connected to one or more electrode leads that are placed into the heart through a vein. Lead failures involving the insulation of the high-voltage part of the ICD lead may cause an electrical short during high-voltage shocks, preventing treatment from being delivered. There are currently limited means for detecting these lead failures. The aim of this study is to collect data to try to detect possible high-voltage insulation breaches.

Who can participate?
Participants aged 18 or over who have been implanted with an ICD and whose defibrillator lead has a possible high-voltage insulation breach

What does the study involve?
Participants wear a Holter monitor for up to 24 hours. A Holter monitor is a portable device that is attached to the skin via electrodes and collects data from the ICD. The collected data is used to try to detect possible high-voltage insulation breaches. Participants are followed up for up to 180 days after Holter monitoring to assess the functioning of their leads.

What are the possible benefits and risks of participating?
Participants may benefit if an insulation breach is detected. There are no risks of participating in the study other than possible mild skin irritation from the Holter monitor electrodes.

Where is the study run from?
Asheville Cardiology Associates (USA)

When is the study starting and how long is it expected to run for?
July 2016 to January 2019

Who is funding the study?
Medtronic (USA)

Who is the main contact?
Scott Sarazin

Trial website

Contact information

Type

Scientific

Primary contact

Mr Scott Sarazin

ORCID ID

Contact details

8200 Coral Sea Street NE
MS: MVS33
Mounds View
55112
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2, 05 APR 2016

Study information

Scientific title

Collect therapy coil electrograms from insulATion breaCHes (CATCH) Study: a prospective non-randomized multi-center post-market feasibility study

Acronym

CATCH

Study hypothesis

The primary objective of the study is to collect electrogram (EGM) data from subjects with potential insulation breaches in the high-voltage portion of defibrillator leads. This feasibility study is not powered to formally test a hypothesis.

Ethics approval

Mission Health Institutional Review Board, 22/06/2016, Ref: 16-06-1578

Study design

Prospective non-randomized multi-center post-market feasibility study

Primary study design

Observational

Secondary study design

Feasibility study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Implanted defibrillator lead high-voltage insulation breach

Intervention

Study subjects will wear a telemetry Holter monitor that stores continuous implanted device data for up to 24 hours. The study will be reviewing electrogram (EGM) data collected by the Holter monitor to try and determine potential lead insulation breaches in the high voltage portion of defibrillation leads. The duration of observation is between 2 and 24 hours. Study follow-up is up to 180 days after Holter monitoring to allow physician to determine lead function status.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Lead insulation breaches in the high-voltage portion of defibrillation leads, measured using EGM data at any time between the end of Holter monitor use to up to 180 days post-Holter use

Secondary outcome measures

There are no secondary outcome measures for this study

Overall trial start date

05/07/2016

Overall trial end date

05/01/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subject (or subject’s legally authorized representative) is willing and able to provide written informed consent
2. Subject is at least 18 years of age (or older, if required by local law)
3. Subject is willing and able to wear a Holter monitor for at least 2 hours and up to 24 hours
4. Subject has been implanted with a Medtronic ICD or CRT-D device
5. Subject’s defibrillator lead has a possible high voltage insulation breach, as suggested by device diagnostics exhibiting any of the following three characteristics:
5.1. Abrupt high voltage impedance decrease (25% decrease in daily impedance from baseline)
5.2. Non-physiologic noise on high voltage EGM
5.3. Less than 50% programmed shock energy delivered

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Subject has medical conditions that would limit study participation (per physician discretion)
2. Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by Medtronic

Recruitment start date

05/07/2016

Recruitment end date

05/01/2019

Locations

Countries of recruitment

United States of America

Trial participating centre

Asheville Cardiology Associates, PA
28803
United States of America

Sponsor information

Organisation

Medtronic, Inc. (USA)

Sponsor details

710 Medtronic Parkway
Minneapolis
55432
United States of America

Sponsor type

Industry

Website

www.medtronic.com

Funders

Funder type

Industry

Funder name

Medtronic

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes