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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Atrial Fibrillation; Arrhythmia; Atrial Fibrillation and Flutter
• Intervention / Treatment: Diagnostic test: Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)

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 Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rhythm monitoring group; 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.	Diagnostic test: Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™); 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).
No Intervention: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint)	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	91 days
Time to detection of a postoperative adverse event	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.	91 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The EQ-5D-5L questionnaire score evolution between inclusion and follow-up consultation	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.	91 days
Number of mayor adverse cardiac outcomes (All-cause death, Ischemic stroke, Myocardial infarction, Systemic embolism)	Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)	Two years
Number of mayor adverse cardiac outcomes (secondary outcome 9) with addition of cardiovascular hospitalisations	Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)	Two years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): July 5, 2023
• Study Completion (Actual): September 4, 2023

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cardiac Surgery; Artificial Intelligence; Digital Health; Postoperative atrial fibrillation (POAF)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Postoperative Complications
• Other Study ID Numbers: S64572

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No