None listed
Conditions
Brief summary
The study aims to evaluate the performance of the Lubdub AECG device compared with a clinically accepted AECG device used in routine clinical care. Participants who are already referred for AECG monitoring will wear both devices at the same time for 24 to 48 hours. The study will assess the technological performance of the Lubdub AECG device during normal daily activities compared to the comparator AECG device. We expect to evaluate if the Lubdub AECG device will provide ECG recordings, signal quality and technological performance comparable to the clinically accepted AECG device, while maintaining high levels of participant usability and comfort.
Interventions
Participants will wear the Lubdub ambulatory electrocardiogram (AECG) device concurrently with a clinically accepted comparator AECG device. The purpose of this study is to evaluate the signal quality and performance of the Lubdub device compared with the comparator device. Clinical diagnosis and patient management will be based exclusively on the comparator device and standard clinical care and will not be influenced by the investigational device.
The Lubdub AECG device is an investigational de
Participants will wear the Lubdub ambulatory electrocardiogram (AECG) device concurrently with a clinically accepted comparator AECG device. The purpose of this study is to evaluate the signal quality and performance of the Lubdub device compared with the comparator device. Clinical diagnosis and patient management will be based exclusively on the comparator device and standard clinical care and will not be influenced by the investigational device. The Lubdub AECG device is an investigational device measuring approximately 150 mm × 150 mm. It has a three-arm design that supports the placement of three electrodes. The device is applied to the skin over the participant's left pectoral region, positioned along the left midclavicular line between the second and third intercostal spaces, to record the heart's electrical activity. Both devices will be applied by appropriately trained study personnel, including research staff and/or healthcare professionals experienced in the application and operation of AECG devices. All study personnel will receive training in the correct application, operation, and removal of the Lubdub AECG device before enrolling participants. The Lubdub AECG device and the comparator AECG device will be fitted and activated simultaneously during a single study visit at the cardiology clinic. Following application, participants will be asked to continue their usual daily activities while wearing both devices throughout the prescribed monitoring period. Participants will wear both the Lubdub AECG device and the comparator AECG device continuously for 24 to 48 hours, depending on the monitoring duration prescribed by their treating physician as part of routine clinical care. The duration of monitoring will be determined by the treating physician based on the participant's clinical presentation, including the frequency of symptoms or suspected arrhythmias. The devices will be applied once at the commencement of monitoring and removed at the completion of the monitoring period. Participant adherence will be assessed using device wear-time records and by reviewing the ECG data collected from both devices. Participants will receive both verbal and written instructions regarding device care, including guidance on maintaining normal daily activities while ensuring the devices remain securely in place throughout the monitoring period
Sponsors
Lubdub Technologies Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The participant has been referred for AECG monitoring as part of routine clinical care. Able and willing to provide written informed consent. Able and willing to wear both the Lubdub AECG device and a comparator AECG device concurrently for the required monitoring period, 24 to 48 hours. Able to comply with study procedures.
Exclusion criteria
Participants undergoing surgery or invasive medical procedures during the monitoring period. Participants with known allergies, skin sensitivities, or dermatological conditions that may preclude safe use of the study devices. Participants with active implantable medical devices.
Outcome results
None listed