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

NCT05509517 | Completed

• 1 other identifier: S64572
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation and Flutter; Atrial Fibrillation; Postoperative Complications; Arrhythmia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

Study Arms (2)

Rhythm monitoring group

EXPERIMENTAL

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™)

Usual care

NO INTERVENTION

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.

Interventions

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).

Rhythm monitoring group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pacemaker dependent heart rhythm
• Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
• No smartphone available at home.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation; Postoperative Complications; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: August 22, 2022
• Study Start: November 2, 2021
• Primary Completion: July 5, 2023
• Study Completion: September 4, 2023
• Last Updated: November 30, 2023

Record last verified: 2022-11

Locations

BE (1)