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

• ClinicalTrials.gov Identifier: NCT05509517
• Recruitment Status: Completed
• First Posted: August 22, 2022
• Last Update Posted: November 30, 2023
• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Information provided by (Responsible Party): Universitaire Ziekenhuizen KU Leuven

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation and Flutter; Atrial Fibrillation; Postoperative Complications; Arrhythmia	Diagnostic Test: Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Remote Heart Rhythm Monitoring Using Photoplethysmography-based Smartphone Technology for the Early Detection of Atrial Fibrillation and Adverse Events After Cardiac Surgery
• Actual Study Start Date: November 2, 2021
• Actual Primary Completion Date: July 5, 2023
• Actual Study Completion Date: September 4, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

   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.

Secondary Outcome Measures :

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)

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Belgium

University Hospitals Leuven

Leuven, Belgium, 3000

Sponsors and Collaborators

Universitaire Ziekenhuizen KU Leuven

More Information

• Responsible Party: Universitaire Ziekenhuizen KU Leuven
• ClinicalTrials.gov Identifier: NCT05509517
• Other Study ID Numbers: S64572
• First Posted: August 22, 2022
• Last Update Posted: November 30, 2023
• Last Verified: November 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitaire Ziekenhuizen KU Leuven:

Atrial Fibrillation; Digital Health; Artificial Intelligence; Cardiac Surgery; Postoperative atrial fibrillation (POAF)

Additional relevant MeSH terms:

Atrial Fibrillation; Postoperative Complications; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes