Clinical trial NCT05509517: A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery
Official title: Remote Heart Rhythm Monitoring Using Photoplethysmography-based Smartphone Technology for the Early Detection of Atrial Fibrillation and Adverse Events After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation and Flutter
Atrial Fibrillation
Postoperative Complications
Arrhythmia
Keywords: Atrial Fibrillation
Digital Health
Artificial Intelligence
Cardiac Surgery
Postoperative atrial fibrillation (POAF)
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to evaluate the clinical consequences following the detection of postoperative atrial fibrillation or flutter (POAF) using a remote heart rhythm monitoring strategy with a photoplethysmography based smartphone technology in the early postoperative period after discharge.

Detailed description: A predefined subgroup analysis of the outcomes described below will be performed in the following subgroups:

* Subjects not on anticoagulation drug therapy (for a planned duration of \>45 days) at discharge.
* Subjects with no history of AF prior to surgery and no POAF lasting \>24h in hospital.
* Subjects with a CHADSVASC score ≥ 4 or a CHADSVASC score ≥ 2 with at least one additional risk factor associated with the risk of developing POAF.

additional risk factors include:

* chronic obstructive pulmonary disease
* sleep apnea
* impaired renal function
* left atrial enlargement
* elevated body mass index
* combined CABG with valve repair or replacement

Eligibility criteria: Inclusion Criteria:

* Subject underwent any of (including a combination of) the following surgical procedures during index hospitalization. (coronary artery bypass graft, surgical repair or replacement of a cardiac valve)
* Subject provides informed consent
* Subject understands and agrees to comply with planned study procedures.
* Subject is able to perform heart rhythm measurement using the FibriCheck application at home.

Exclusion Criteria:

* Pacemaker dependent heart rhythm
* Permanent AF/Aflutter or AF/Aflutter present at the time of inclusion
* Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
* No smartphone available at home.

Primary outcomes:
measure: Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint)
timeFrame: 91 days
measure: Time to detection of a postoperative adverse event
timeFrame: 91 days
Secondary outcomes:
measure: Time to primary endpoint (primary outcome 1)
timeFrame: 91 days
measure: Proportion of participants with initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection
timeFrame: 91 days
measure: Post-operative atrial fibrillation (POAF) detection rate
timeFrame: 91 days
measure: Time to POAF detection
timeFrame: 91 days
measure: POAF detection rate in subjects with an indication for anticoagulation
timeFrame: 91 days
measure: Detection rate of POAF lasting more than 6 hours
timeFrame: 91 days
measure: The EQ-5D-5L questionnaire score evolution between inclusion and follow-up consultation
timeFrame: 91 days
measure: Number of mayor adverse cardiac outcomes (All-cause death, Ischemic stroke, Myocardial infarction, Systemic embolism)
timeFrame: Two years
measure: Number of mayor adverse cardiac outcomes (secondary outcome 9) with addition of cardiovascular hospitalisations
timeFrame: Two years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References: