ECG Validation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-19

Study Completion Date

2023-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

NCT04865640

Cardiopulmonary Disease

COMPLETED

Clinical Validation Study for CPM Device

NCT05445206

Heart Failure

COMPLETED NA

Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch

NCT04176926

Atrial Fibrillation

COMPLETED

Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring

NCT06422468

Atrial Fibrillation

RECRUITING NA

Clinical Data Collection Study Using CPM System

NCT06007079

Heart Failure

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Comparison of test device ECG to reverence device ECG.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Cardiologist that interpret ECG strips to not know which strip is from the reference device and which is from the test device.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy

Generally healthy participants that are able to participate in study procedures (i.e. laying down, sitting up, shaving chest hair for ECG/Test device placement if needed).

Group Type ACTIVE_COMPARATOR

CPM Device

Intervention Type DEVICE

CPM device used in tangent with reference ECG for validation

Atrial Fibrillation Diagnosis

Participants with a diagnosis of atrial fibrillation that are able to participate in study procedures (i.e. laying down, sitting up, shaving chest hair for ECG/Test device placement if needed).

Group Type ACTIVE_COMPARATOR

CPM Device

Intervention Type DEVICE

CPM device used in tangent with reference ECG for validation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CPM Device

CPM device used in tangent with reference ECG for validation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Able to provide written, informed consent
* Individuals 18 years of age and older
* Willing and able to participate in the study procedures
* If in AF cohort: subjects must have a known diagnosis of AF

Exclusion Criteria

* Known allergy or sensitivity to ECG electrodes or any other silicone-based electrodes
* Injury or skin disturbance in the area of the test device or reference device
* Acute myocardial infarction within 90 days of screening or other cardiovascular diseases that increases subject risk or renders data uninterpretable (by discretion of the investigator)
* Stroke or TIA within 90 days of screening
* Significant tremor that prevents subject from being still
* History of abnormal life-threatening arrhythmias (by discretion of the investigator)
* Pregnant (method of assessment at study physician's discretion)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes