SyncopePANDANCT07118124
Pediatric Adhesion and New Dermal Approach Study
A study testing Zio monitor in people with Syncope and Pediatric, run by iRhythm Technologies, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Syncope, Pediatric, Congenital Athymia
- What is being tested?
- Zio monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Aug 2025to 13 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is <18 years of age and ≥1 year of age and weighing ≥10 kg (22 pounds) at the time of device application.
- Child's legally authorized representative is willing and able to provide informed consent and be able to assist the Child in completing all visits for the study. If the Child is old enough to provide assent, it will also be captured.
- The prescribed Zio monitor wear time is planned to be up to 14 days.
Who cannot join
- Child has a known allergy to adhesives or hydrogels or with family history of adhesive skin allergies.
- Child has a visible skin injury or broken skin at location for study device placement.
- Child has skin damage and a discharge of clear fluid or pus at the location for study device placement.
- Child is unable or unwilling to participate or comply with study protocol.
- The local Investigator deems the Child has a condition that could limit the Child's ability or willingness to participate in the study, or ability to comply with study required procedures and/or follow-up visits. (It is understood that younger age groups of children may present development behavioral challenges in compliance with use of medical devices. Normal development stage should not be considered a reason for exclusion).
- The child has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the child or when real-time or in-patient monitoring should be prescribed.
- Child has an external or wearable cardiac defibrillator or may be exposed to high frequency surgical equipment near strong magnetic fields or devices such as MRI during the wear period.
- Child has a neuro-stimulator, as it may disrupt the quality of ECG data.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
St. Luke's Children's Hospital
Boise, Idaho, 83712
Boston Children's Hospital
Boston, Massachusetts, 02115
WashU Medicine
St Louis, Missouri, 63110
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Pediatric Adhesion and New Dermal Approach Study (PANDA)
The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. The Zio® monitor (Study Device) is an adhesive patch that is worn on the upper left chest for a specified period of time and is similar to a band aid. The Study Device contains a battery-powered heart monitor and will look at the heart rhythm and rate.
Read the detailed description
This is a prospective single-arm study to demonstrate adequate analyzable time for use in pediatric patients up to 14 days of device wear. The study will incorporate a simplified skin preparation procedure. The objective is to evaluate analyzable time of the Zio® monitor device over the wear duration (up to 14 days) in a population 1 to 17 years of age. The study will incorporate a simplified skin preparation procedure.
- Conditions
- Syncope, Pediatric, Congenital Athymia, Congenital Heart Disease, Arrhythmia, Arrhythmia in Children
- Being tested
- Zio monitor
- Keywords
- Pediatrics, PANDA Study, Zio monitor, Children, arrhythmia in children
- Medical subject headings
- Syncope, Heart Defects, Congenital, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zio monitorDevice
Evaluate analyzable time of the Zio monitor over the wear duration of up to 14 days in a pediatric population.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm study to analyzable time for use in pediatric patients up to 14 days | Other | Zio monitor Receives: Device: Zio monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Objective
The duration of non-artifact ECG signal as a proportion of the device total wear time will be assessed. The sample proportion with analyzable time >80% is assumed to be 90%. The performance objective will be met if the lower bound of the 95% confidence interval is at least 75%. Percent analyzable time is defined as the duration of non-artifact ECG signal as a proportion of the device total wear time.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Aug 2025
- Primary completion26 Sep 2025
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- iRhythm Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Berul, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118124
- Sponsor's protocol ID
- iRT-001-2025
- Acronym
- PANDA
- Status last verified
- May 2026
- First submitted
- 5 Aug 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Adhesion and New Dermal Approach Study (PANDA)
- ClinicalTrials.gov ID
- NCT07118124
- Acronym / sponsor ID
- PANDA / iRT-001-2025
- Conditions
- Syncope, Pediatric, Congenital Athymia, Congenital Heart Disease, Arrhythmia, Arrhythmia in Children
- Keywords
- Pediatrics, PANDA Study, Zio monitor, Children, arrhythmia in children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- iRhythm Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. The Zio® monitor (Study Device) is an adhesive patch that is worn on the upper left chest for a specified period of time and is similar to a band aid. The Study Device contains a battery-powered heart monitor and will look at the heart rhythm and rate.
Detailed description
This is a prospective single-arm study to demonstrate adequate analyzable time for use in pediatric patients up to 14 days of device wear. The study will incorporate a simplified skin preparation procedure. The objective is to evaluate analyzable time of the Zio® monitor device over the wear duration (up to 14 days) in a population 1 to 17 years of age. The study will incorporate a simplified skin preparation procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm study to analyzable time for use in pediatric patients up to 14 days | Other | Device: Zio monitorZio monitor |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child is <18 years of age and ≥1 year of age and weighing ≥10 kg (22 pounds) at the time of device application.
- Child's legally authorized representative is willing and able to provide informed consent and be able to assist the Child in completing all visits for the study. If the Child is old enough to provide assent, it will also be captured.
- The prescribed Zio monitor wear time is planned to be up to 14 days.
Key exclusion criteria (8 listed)
- Child has a known allergy to adhesives or hydrogels or with family history of adhesive skin allergies.
- Child has a visible skin injury or broken skin at location for study device placement.
- Child has skin damage and a discharge of clear fluid or pus at the location for study device placement.
- Child is unable or unwilling to participate or comply with study protocol.
- The local Investigator deems the Child has a condition that could limit the Child's ability or willingness to participate in the study, or ability to comply with study required procedures and/or follow-up visits. (It is understood that younger age groups of children may present development behavioral challenges in compliance with use of medical devices. Normal development stage should not be considered a reason for exclusion).
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 |
|---|---|---|
| Zio monitorEvaluate analyzable time of the Zio monitor over the wear duration of up to 14 days in a pediatric population. | Device | Single-arm study to analyzable time for use in pediatric patients up to 14 days |
Primary outcome
Performance Objective
Time frame: Up to 14 days
The duration of non-artifact ECG signal as a proportion of the device total wear time will be assessed. The sample proportion with analyzable time >80% is assumed to be 90%. The performance objective will be met if the lower bound of the 95% confidence interval is at least 75%. Percent analyzable time is defined as the duration of non-artifact ECG signal as a proportion of the device total wear time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Syncope
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
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.
Charles Berul, MD principal investigator
Children's National Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zio monitor in people with Syncope and Pediatric, run by iRhythm Technologies, Inc. at 4 sites in United States.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance Objective (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.