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Using Innovative Technology to Identify Postoperative Atrial Fibrillation in cardiac surgical patients after hospital discharge (iTIP)

Identifying postoperative Atrial Fibrillation in cardiac surgical patients after hospital discharge using an iPhone electrocardiogram (ECG)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000383662
Acronym
iTIP
Enrollment
44
Registered
2014-04-09
Start date
2014-04-01
Completion date
2015-06-16
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

AF is a major health and economic burden. Post-operative AF is thought to be mainly transient and reversible, however, there is very limited information about how often it may recur. Some research suggests it affects up to 8% of patients in the two years following surgery, but this is likely an under-estimate of the actual rate, as AF is often asymptomatic and there is no routine surveillance. The rationale for this study is to determine if a brief intervention increases knowledge about AF symptoms and whether a simple iPhone based handheld ECG device could be utilised to identify AF when recordings are obtained by post-operative cardiothoracic surgical patients.

Interventions

Patients will receive individualised education regarding atrial fibrillation (AF) and its health risks, and will be provided with education materials to take home. All consenting patients will be provided with a handheld iPhone ECG device (iECG); called the AliveCor Heart monitor which is an approved medical device (ARTG Identifier 208100). The iECG is a special cover that attaches to an iPhone, which enables a single lead ECG reading to be taken using an application on the iPhone. Patients wil

Patients will receive individualised education regarding atrial fibrillation (AF) and its health risks, and will be provided with education materials to take home. All consenting patients will be provided with a handheld iPhone ECG device (iECG); called the AliveCor Heart monitor which is an approved medical device (ARTG Identifier 208100). The iECG is a special cover that attaches to an iPhone, which enables a single lead ECG reading to be taken using an application on the iPhone. Patients will be taught how to record their own iECG. Patients will be asked to record an iECG four times per day for four weeks. Recordings will be spread out through the day at times suitable to the patient (e.g. Immediately before breakfast, lunch, dinner and sleep). Patients will also be advised to take additional iECG recordings, as soon as practicable, if they experience AF symptoms. Each iECG will be automatically transmitted to a secure server where each iECG will be analysed by the automated algorithm. iECGs will be monitored and reviewed by the research assistant for the presence of AF and also to ensure that patients are performing their ECG recordings. If AF, or any other clinically significant event is identified, the research assistant will contact the patient and advise them to arrange for urgent follow-up with their treating doctors, and will advise the treating doctor and specialists of the findings. Patients will also be asked to keep an AF symptom recurrence checklist for 4 weeks. They will be asked to self-report on the occurrence of AF, AF-related symptoms including palpitations, dizziness and syncope, and any medical or hospital presentation related to these.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age over 18 years, who have experienced postoperative AF following cardiac surgery and have reverted or been cardioverted back to sinus rhythm prior to discharge, and who have additional AF risk factors (eg. aged greater than or equal to 65 years, valve surgery, heart failure, or hypertension).

Exclusion criteria

Patients will be excluded if they are non-English speaking, have insufficient cognitive capacity for the consent and interview process, are not returning home (transferred to rehabilitation service), or do not have a telephone

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 5, 2026