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
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 measure
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 (if study stopped)
Participant recruitment issue
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
Funders
Funder type
Industry
Funder name
Medtronic
Alternative name(s)
Medtronic Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Basic results (scientific)
Publication list