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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2026
  • participants needed
    600
  • sponsor
    Universitaire Ziekenhuizen Leuven
Updated on 4 October 2022
diagnostic procedure
fibrillation
coronary artery bypass graft

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.

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

Details
Condition Atrial Fibrillation and Flutter, Atrial Fibrillation, Postoperative Complications, Arrhythmia
Treatment Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)
Clinical Study IdentifierNCT05509517
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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