Hope Research Institute
Phoenix, Arizona, 85018, United States
NCT Number: NCT05445726
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 2
Phoenix, Arizona, 85018, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CPM device used in tangent with reference ECG for validation
Time frame: Baseline
Test device AFIB detection vs reference device
Time frame: Baseline
Test device NSR detection vs reference device
Time frame: Baseline
Test device ECG strip vs reference device
Analog Device, Inc.
Other
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06808217
Arrhythmias, Cardiac, Atrial Fibrillation
Vienna, Austria
View Trial DetailsNCT05501873
Arrhythmias, Cardiac, Atrial Fibrillation
Brisbane, Australia
View Trial DetailsNCT06748157
Arrhythmias, Cardiac, Atrial Fibrillation
New York, United States
View Trial DetailsNCT06521463
Arrhythmias, Cardiac, Atrial Fibrillation
Birmingham, Alabama, United States
View Trial Details