CompletedNot Applicable

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

Belgium450 participantsStarted 2021-11-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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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.

What they're measuring

Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint)

Timeframe: 91 days

Time to detection of a postoperative adverse event

Timeframe: 91 days

Trial details

NCT IDNCT05509517

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-05

View on ClinicalTrials.gov More Atrial Fibrillation and Flutter trials