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NCT07118124 · ClinicalTrials.gov registry record · NA
Pediatric Adhesion and New Dermal Approach Study
A NA study of Congenital Heart Disease and Arrhythmia, sponsored by iRhythm Technologies.
- Active
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 4
- Study locations
NCT07118124: Active NA study of Congenital Heart Disease and Arrhythmia, sponsored by iRhythm Technologies.
NCT07118124 is a NA study of Congenital Heart Disease and Arrhythmia that is active but no longer recruiting, run by iRhythm Technologies. The registered enrollment target is 36 participants, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07118124, a NA study of Congenital Heart Disease and Arrhythmia, is active but no longer recruiting, sponsored by iRhythm Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 4
- Study locations
Study 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. 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Zio monitor
Study Locations (4)
District of Columbia
- Children's National Hospital - Washington D.C.
Idaho
- St. Luke's Children's Hospital - Boise
Massachusetts
- Boston Children's Hospital - Boston
Missouri
- WashU Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-08-15 |
| Est. Completion | 2026-03 |
| Phase | NA |
What the registry record for NCT07118124 still lists
NCT07118124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (92% lower).
The record links to 6 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Zio monitor is the first listed.
NCT07118124 reports a single indexed study location in District of Columbia, Idaho, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07118124 about?
NCT07118124 is a clinical study titled "Pediatric Adhesion and New Dermal Approach Study". 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 l...
What is the current status of trial NCT07118124?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2025-08-15. Estimated completion is 2026-03.
What conditions does trial NCT07118124 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Arrhythmia, Syncope, Pediatric, Congenital Athymia.
What interventions are being tested in trial NCT07118124?
The interventions under investigation include: Zio monitor (DEVICE).
Who is sponsoring clinical trial NCT07118124?
This trial is sponsored by iRhythm Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07118124 being conducted?
This trial has 4 study locations across District of Columbia, Idaho, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07118124's enrollment target sits among peer trials
36 52nd of 63 higher than 11 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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