- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05560828
Zio Real-World Evaluation
A Multi-centre Cohort Study Comparing Health Outcome Data From Holter Monitoring to 14 Day Zio Monitoring in People Where Ambulatory ECG Monitoring is Required
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed study is a multi-centre, cohort study that will collect 6-month control data from a cohort of participants wearing Holter devices (2018-2019) and match this data to a 6-month cohort of patients wearing Zio patches (2021 - 2022). An additional cohort of patients using the Zio patch from both the cardiology and stroke/TIA population will be included for the patient experience aspect of the study.
Other designs have been considered but from a pragmatic point of view and the need for a "real-world" evaluation this is the preferred alternative with the caveat that there may not be an exact match between the two patient groups.
The proposed study is a multi-centre, cohort study that will collect 6-month baseline data from a retrospective cohort of participants wearing Holter devices and match this data to a 6-month retrospective cohort of patients wearing Zio patches. Zio is standard of care at the NHS sites participating in this study, but it is not standard of care across the NHS. The standard of care received by patients involved in this study will not be affected by their participation in the study. However, should Zio be adopted more widely by the NHS, a change in pathway will be required. The Zio device is CE marked as a Class IIa and will be used within its intended purpose.
Two separate populations will be considered for this study: cardiology outpatients and patients at risk of (or who have had a previous) stroke or TIA. Each of these populations will comprise a control cohort for Holter monitor and a cohort for Zio service, which will be analysed separately. A separate cohort comprising of participants prescribed Zio will be included in a qualitative analysis to assess their experience of using Zio and previous experience of using Holter monitor within the past 2 years, where applicable. This will allow for a comparative analysis of patient experience. For patients in the cohort who have not had prior experience of using Holter monitor, a questionnaire will be administered to assess their experience of using Zio only.
Given the potential for a shift in the spectrum of the population that may be expected when Zio is implemented, propensity score matching will be utilised to compare the Holter and Zio cohorts for both the stroke/TIA and cardiology arms.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Anna Barnes
- Phone Number: 020 784 89527
- Email: anna.barnes@kcl.ac.uk
Study Contact Backup
- Name: Sarah Hammoudi
- Phone Number: 020 784 89527
- Email: sarah.hammoudi@kcl.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Data from stroke/TIA population:
- 18 years of age or older
- diagnosed with having had an ischaemic non-lacunar stroke or probable TIA by a stroke clinician or neurologist.
- Referred for ambulatory ECG monitoring
Data from cardiology population:
- 18 years of age or older
- experiencing symptomatic palpitations, dizziness, pre-syncope or syncope
- Referred for ambulatory ECG monitoring
Qualitative data will be collected via self-administered questionnaires from healthcare professionals who:
• are involved in prescribing the Zio XT service, fitting the Zio patch, interpreting the Zio report and making a treatment decision.
Qualitative data will be collected via self-administered questionnaires from patients who:
- are 18 years of age or older
- have been prescribed the Zio patch
- have been prescribed the Zio patch and the Holter monitor (within two years)
Exclusion Criteria:
Data from stroke/TIA population:
- History of AF or atrial flutter
- > 50% stenosis of a potentially symptomatic cervical artery (carotid or vertebral)
- Pre-existing indication or contraindication for permanent anticoagulation therapy
- Significant uncertainty of TIA diagnosis such as cases where TIA treatment isn't initiated
- New lacunar stroke reported on imaging which corresponds to the presenting stroke syndrome
Data from cardiology population:
Patients in whom 24-hour monitoring is required due to the following reasons:
- experiencing daily symptoms
- the need for AF rate control measurement
- the need for ectopic burden measurement
- Patients who are prescribed Implantable Loop Recorders and pacemakers in situ
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Zio Cohort
Patients who have been prescribed Zio
|
There will be no intervention.
Standard of care at participating NHS organizations will not be affected.
|
Holter Cohort
Patients who have been prescribed Holter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to device being fitted
Time Frame: 6 months
|
Time to device being fitted
|
6 months
|
Time to diagnosis
Time Frame: 6 months
|
Time to diagnosis
|
6 months
|
Time to treatment decision
Time Frame: 6 months
|
Time to treatment decision - referral for anticoagulant prescription or other clinical intervention, where needed
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resource utilisation
Time Frame: 6 months
|
Resource utilisation
|
6 months
|
Time to ECG report
Time Frame: 6 months
|
Time to ECG report
|
6 months
|
Time to repeat ambulatory ECG test referrals
Time Frame: 6 months
|
Time to repeat ambulatory ECG test referrals
|
6 months
|
Number of insertable cardiac monitors such as LINQ implants
Time Frame: 6 months
|
Number of insertable cardiac monitors such as LINQ implants
|
6 months
|
Number of hospital visits
Time Frame: 6 months
|
Number of hospital visits
|
6 months
|
Number of inconclusive follow-up appointments
Time Frame: 6 months
|
Number of inconclusive follow-up appointments
|
6 months
|
Number of device failures / adverse events
Time Frame: 6 months
|
Number of device failures / adverse events
|
6 months
|
Proportion of patients that undergo full monitoring following referral
Time Frame: 6 months
|
Proportion of patients that undergo full monitoring following referral
|
6 months
|
Diagnostic yield
Time Frame: 6 months
|
Diagnostic yield
|
6 months
|
"Rule out"
Time Frame: 6 months
|
"Rule out" - number of patients with non-clinically significant arrhythmia
|
6 months
|
Time to discharge of patients with non-clinically significant cardiac arrhythmia
Time Frame: 6 months
|
Time to discharge of patients with non-clinically significant cardiac arrhythmia
|
6 months
|
Settlement of patient's GP surgery - urban or rural area
Time Frame: 6 months
|
Settlement of patient's GP surgery - urban or rural area
|
6 months
|
Patient experience
Time Frame: 6 months
|
Patient experience of using Zio
|
6 months
|
Clinical experience of using Zio
Time Frame: 6 months
|
Clinical experience of using Zio
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KCLAI001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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