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Completed

NCT Number: NCT05509517

A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone 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.

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Key information

Conditions

Atrial Fibrillation and Flutter Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

Heart Rhythm assessment using the FibriCheck™ application with the patient's proprietary smartphone, three times daily, from discharge until follow-up consultation (day 21-91 after discharge).

Primary outcomes

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

    Time frame: 91 days

    Any of the following therapeutic interventions:

    • Initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection
    • Initiation or increase in dose regimen of anti-arrhythmic drug therapy (Vaughan-williams class 1 or 3)
    • Cardioversion
    • Cardiac implantable electronic device (CIED) implantation

  2. Time to detection of a postoperative adverse event

    Time frame: 91 days

    Prespecified postoperative adverse events:

    1.1. Acute respiratory insufficiency 1.2. Pleural effusion 1.3. Pneumonia 1.4. Pulmonary Embolism 1.5. Pneumothorax 1.6. Atelectasis, leading to respiratory insufficiency

    2.1. Acute myocardial infarction 2.2. Symptomatic arrhythmia 2.3. Pericardial effusion 2.4. Pericarditis 2.5. Endocarditis 2.6. Systemic embolism 2.7. Cardiogenic shock

    3.1. Acute stoke including cerebrovascular accident (CVA) and transient ischemic attack (TIA)

    4.1. Renal failure, defined as: >50% increase in serum creatinine or initiation of renal replacement therapy 4.2. Urinary tract infection, requiring antibiotic treatment

    • Wound related complications requiring surgical intervention or antibiotic treatment.
    • Sepsis
    • Other unplanned hospitalisations will be classified by the research team as 'postoperative adverse event' or 'unrelated to the cardiac surgery procedure'. Such events will be reported with the study results.

Secondary outcomes

  1. Time to primary endpoint (primary outcome 1)

    Time frame: 91 days

  2. Proportion of participants with initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection

    Time frame: 91 days

  3. Post-operative atrial fibrillation (POAF) detection rate

    Time frame: 91 days

  4. Time to POAF detection

    Time frame: 91 days

  5. POAF detection rate in subjects with an indication for anticoagulation

    Time frame: 91 days

  6. Detection rate of POAF lasting more than 6 hours

    Time frame: 91 days

  7. The EQ-5D-5L questionnaire score evolution between inclusion and follow-up consultation

    Time frame: 91 days

    EQ-5D-5L is a EuroQol five-dimension scale questionnaire. The participant rates his or her own level of impairment across dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) from 1 to 5 and global health rating on a visual analogue scale (EQ-VAS) from 1 to 100.

  8. Number of mayor adverse cardiac outcomes (All-cause death, Ischemic stroke, Myocardial infarction, Systemic embolism)

    Time frame: Two years

    Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)

  9. Number of mayor adverse cardiac outcomes (secondary outcome 9) with addition of cardiovascular hospitalisations

    Time frame: Two years

    Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: SURGICAL-AF 2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2022
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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