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

Atrial Fibrillation Clinical Trial

— SURGICAL-AF 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05509517
• Other study ID #: S64572
• Status: Completed
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: September 4, 2023

Study information

• Verified date: November 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: September 4, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation
• Atrial Fibrillation and Flutter
• Postoperative Complications

Intervention

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).

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to primary endpoint (primary outcome 1)		91 days
Secondary	Proportion of participants with initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection		91 days
Secondary	Post-operative atrial fibrillation (POAF) detection rate		91 days
Secondary	Time to POAF detection		91 days
Secondary	POAF detection rate in subjects with an indication for anticoagulation		91 days
Secondary	Detection rate of POAF lasting more than 6 hours		91 days
Secondary	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
Secondary	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
Secondary	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