NCT05445726Active, not recruitingPhase 2
ECG Validation Study
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
Source: ClinicalTrials.gov · Last updated 6 Oct 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 141 (actual)
- First submitted
- 30 Jun 2022
- Start date
- 19 May 2022
- Primary completion date
- 2 Sept 2022
- Lead sponsor
- Analog Device, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT05445726
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 141
- From 19 May 2022 to the primary completion date, 2 Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy or sensitivity to ECG electrodes or any other silicone-based electrodes
- 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
- History of abnormal life-threatening arrhythmias (by discretion of the investigator)
Other
- Injury or skin disturbance in the area of the test device or reference device
- Significant tremor that prevents subject from being still
- Pregnant (method of assessment at study physician's discretion)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hope Research Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.