A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery (SURGICAL-AF 2)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Postoperative Complications; Arrhythmia; Atrial Fibrillation; Atrial Fibrillation and Flutter

Treatments: Diagnostic Test: Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)

Study type: Interventional

Funder types: Other

Identifiers

NCT05509517

S64572

Details and patient eligibility

About

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.

Full 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

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Rhythm monitoring group

Experimental group

Description:

Patients randomized to the rhythm monitoring arm will assess their heart rhythm with a photoplethismography (PPG) based smartphone application (FibriCheck™). Measurements are performed three times daily and while experiencing symptoms. The patients start measuring immediately after discharge and continues until the scheduled postoperative consultation with the cardiologist or cardiac surgeon at 21-91days after discharge.

Treatment:

Diagnostic Test: Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)

Usual care

No Intervention group

Description:

Patients randomized to the rhythm monitoring arm will be discharged without protocol mandated rhythm monitoring. A postoperative consultation is scheduled with the cardiologist or cardiac surgeon at 21-91days after discharge.