None listed
Conditions
Brief summary
This study will be conducted to determine if smart phone-based (Kardiamobile) single lead electrographic (sECG) recording systems have a superior yield for the diagnosis of hearth rhythm disorders compared to repeating traditional ambulatory monitoring (Holter) in patients with undiagnosed palpitations. Participants who meet the inclusion criteria will be randomised 1:1 to either the intervention group (Kardiamobile sECG) or control group (standard care with multiple ambulatory Holter monitors). This clinical trial will run over 2 years with a planned recruitment of 80 patients (40 in each group). A follow up period of 6 months will aid to determine which approach is superior for the diagnosis of symptom related-heart rhythm abnormalities. Control arm Patients randomised to the control arm will be managed as per standard care. Standard care will comprise of sequential ambulatory multi-day Holter monitors (5 days), up to 3 in number, over a period of 6 months, separated by at least 4 weeks. Intervention arm Patients randomised to the intervention arm will be offered the Alivecor KARDIAMOBILE (Smart phone-based sECG). The smartphone/smartwatch platform allows a single lead ECG recording of up to 5 minutes. Study outcomes The primary outcome of this study will be the proportion of patients in whom a definite diagnosis of palpitations is made with an underlying rhythm that correlated with symptoms (symptom-rhythm correlation) or a serious rhythm abnormality is recorded over the 6 month follow up period.
Interventions
Patients randomised to the intervention arm will be offered the Alivecor KARDIAMOBILE (Smart phone-based sECG). They will be taught how to use the device using proprietary videos available on the manufacturer’s website (https://www.alivecor.com/how-it-works/). The smartphone/smartwatch platform allows a single lead ECG recording of up to 5 minutes. A finger from each (or one) hand is placed on electrodes on the back of a smartphone case (Kardiamobile), or an Apple watch band (KARDIABAND), result
Patients randomised to the intervention arm will be offered the Alivecor KARDIAMOBILE (Smart phone-based sECG). They will be taught how to use the device using proprietary videos available on the manufacturer’s website (https://www.alivecor.com/how-it-works/). The smartphone/smartwatch platform allows a single lead ECG recording of up to 5 minutes. A finger from each (or one) hand is placed on electrodes on the back of a smartphone case (Kardiamobile), or an Apple watch band (KARDIABAND), resulting in a standard Lead I ECG recording which will aid diagnosis of arrhythmias. Patients will be asked to: a. Record and transmit a baseline sECG, save it as a PDF file and email to the secure server set up at Westmead Hospital, by using their de-identified study code in the subject line. This will also serve as their ‘test’ of usability; b. Record and transmit an indefinite number of sECGs during the time they experience subjective palpitations; c. Mandatory recording and transmitting an sECG on a minimum of once daily basis, but encouraged to send a sECG transmission twice daily (morning and night). The daily transmissions will monitor adherence. The follow-up and monitoring duration of the intervention group will last for a maximum of 6 months unless a definitive diagnosis is reached before that time, in which then the patient will no longer require monitoring.
Sponsors
Western Sydney Local Health District (WSLHD)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged greater than or equal to 18 years; 2. Symptomatic palpitations in whom initial 12 lead ECG has failed to detect arrhythmia. 3. At least two episodes of palpitations in the preceding 6 months; 4. Have a smartphone and/or a smartwatch capable of running the Alivecor application.
Exclusion criteria
Patients will be excluded if they are: 1. are unable or unwilling to provide informed consent; 2. Patients in whom palpitations are known to have a physiologic such as anaemia, thyroid dysfunction, heart failure, or women who are pregnant or breast feeding; 3. Concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary care physician could interfere with the conduct of the study including outcome assessments; 4. Inability or unwillingness to provide written informed consent; 5. Unable to complete study procedures; 6. Medical illness with anticipated life expectancy < 3 months; 7. Responsible primary care or other responsible physician believes it is not appropriate to participate in the study. 8. poor baseline sECG recording; 9. Lack of understanding of how to record sECG after initial consultation. 10. Do not have a smartphone and/or a smartwatch that is compatible with running the Alivecor application.
Outcome results
None listed