Collect therapy coil electrograms from insulation breaches study
| ISRCTN | ISRCTN10583311 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10583311 |
| Secondary identifying numbers | Version 2, 05 APR 2016 |
- Submission date
- 28/07/2016
- Registration date
- 17/08/2016
- Last edited
- 31/10/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
8200 Coral Sea Street NE, MS: MVS33
Mounds View
55112
United States of America
Study information
| Study design | Prospective non-randomized multi-center post-market feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Feasibility study |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Collect therapy coil electrograms from insulATion breaCHes (CATCH) Study: a prospective non-randomized multi-center post-market feasibility study |
| Study acronym | CATCH |
| Study objectives | 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(s) | Mission Health Institutional Review Board, 22/06/2016, Ref: 16-06-1578 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 05/07/2016 |
| Completion date | 05/01/2019 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/07/2016 |
| Date of final enrolment | 05/01/2019 |
Locations
Countries of recruitment
- United States of America
Study participating centre
United States of America
Sponsor information
Industry
710 Medtronic Parkway
Minneapolis
55432
United States of America
| Website | www.medtronic.com |
|---|---|
"ROR" |
https://ror.org/00grd1h17 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Editorial Notes
31/10/2017: Internal review.
02/03/2017: The study was stopped on 21/02/2017 due to a participant recruitment issue.
