A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery

Remote Heart Rhythm Monitoring Using Photoplethysmography-based Smartphone Technology for the Early Detection of Atrial Fibrillation and Adverse Events After Cardiac Surgery

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.

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

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.