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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 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.

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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.

Conditions Studied

Interventions

  • DEVICE CPM Device

Study Locations (1)

Arizona

  • Hope Research Institute - Phoenix

Trial Details

FieldValue
Enrollment Target 141 participants
Start Date 2022-05-19
Est. Completion 2023-11-01
Phase Phase 2

Sponsor

Analog Device

5 total trials

What the Registry Record Tells You About NCT05445726

The ClinicalTrials.gov registry entry for NCT05445726 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (95% lower). The listed sponsor is Analog Device, which has 5 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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