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

Not Applicable

Completed

• Conditions: Arrhythmia; Atrial Fibrillation and Flutter; Postoperative Complications; Atrial Fibrillation
• Interventions: Diagnostic Test: Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)

• Registration Number: NCT05509517
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2021-11-02
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-22
• Status Verified: 2022-11
• Primary Completion: 2023-07-05
• Study Completion: 2023-09-04
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rhythm monitoring group	Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)	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.

Primary Outcome Measures

Name	Time	Method
Time to detection of a postoperative adverse event	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; 5. Wound related complications requiring surgical intervention or antibiotic treatment.; 6. Sepsis; 7. 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.
Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint)	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

Secondary Outcome Measures

Name	Time	Method
The EQ-5D-5L questionnaire score evolution between inclusion and follow-up consultation	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.
Number of mayor adverse cardiac outcomes (All-cause death, Ischemic stroke, Myocardial infarction, Systemic embolism)	Two years	Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)
Time to primary endpoint (primary outcome 1)	91 days
Proportion of participants with initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection	91 days
Post-operative atrial fibrillation (POAF) detection rate	91 days
Time to POAF detection	91 days
POAF detection rate in subjects with an indication for anticoagulation	91 days
Detection rate of POAF lasting more than 6 hours	91 days
Number of mayor adverse cardiac outcomes (secondary outcome 9) with addition of cardiovascular hospitalisations	Two years	Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium