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NCT05445726 · ClinicalTrials.gov registry record · Phase 2
ECG Validation Study
A Phase 2 study of Atrial Fibrillation, sponsored by Analog Device.
- Active
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
- 1
- Study location
NCT05445726: Active Phase 2 study of Atrial Fibrillation, sponsored by Analog Device.
NCT05445726 is a Phase 2 study of Atrial Fibrillation that is active but no longer recruiting, run by Analog Device. The registered enrollment target is 141 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05445726, a Phase 2 study of Atrial Fibrillation, is active but no longer recruiting, sponsored by Analog Device.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
- 1
- Study location
Study Summary
Subjects will be recruited and begin the study as they are identified and consent to the study. Recruiting can end when 140 subjects have initiated the study. The study does allow for additional subjects to be recruited if resources allow, leading to approximately 160 subjects. At the approximate midpoint of the study, intermediate data analysis will be performed. Enrollment will continue while this occurs. Upon arrival to the clinic on the day of the study visit, prior to the application of the reference and test devices, skin inspection of the application site will be conducted. The reference ECG device will be applied, and two initial ECGs will be taken. The precordial leads from the reference device will then be removed from the patient and the CPM Device will be applied to the participant's chest as described in the IFU materials supplied with the device (the study team will also have received training on the proper placement of the device prior to the initiation of the study). This device will be worn for the remainder of the clinic visit. On the CRF, the time that the CPM Device is placed on the chest will be denoted. The reference device and the test device will then take 2 additional ECG measurements simultaneously. During ECG measurements involving CPM device, it will be helpful to maintain silence during the entire measurement duration, as it helps the device to gather heart sounds signals without interference. The ECG results will be analyzed by certified medical personnel, where they will be asked to annotate various parameters of the ECGs. The certified medical personnel will then be asked to classify the ECGs and about the strips' clinical usability.
Primary Outcome
Test device AFIB detection vs reference device
Conditions Studied
Interventions
- DEVICE CPM Device
Study Locations (1)
Arizona
- Hope Research Institute - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2022-05-19 |
| Est. Completion | 2023-11-01 |
| Phase | Phase 2 |
What the registry record for NCT05445726 still lists
NCT05445726 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which CPM Device is the first listed.
NCT05445726 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT05445726 about?
NCT05445726 is a clinical study titled "ECG Validation Study". Subjects will be recruited and begin the study as they are identified and consent to the study. Recruiting can end when 140 subjects have initiated the study. The study does allow for additional subjects to be recruited if resources allow, leading to approximately 160 subjects. At the approximate mi...
What is the current status of trial NCT05445726?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2022-05-19. Estimated completion is 2023-11-01.
What conditions does trial NCT05445726 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT05445726?
The interventions under investigation include: CPM Device (DEVICE).
Who is sponsoring clinical trial NCT05445726?
This trial is sponsored by Analog Device, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05445726 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atrial Fibrillation
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Where NCT05445726's enrollment target sits among peer trials
141 125th of 202 higher than 78 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation 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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