The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery

Overview

The aim of this study is to investigate the occurrence of new-onset postoperative atrial fibrillation after totally endoscopic cardiac surgery.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Diagnostic
  • Masking: None (Open Label)
• Study Primary Completion Date: July 2, 2024

Interventions

• Device: FibriCheck
  • During the patient’s intensive care unit (ICU) stay, they will be monitored constantly to detect atrial fibrillation (standard care). After ICU dismissal, patients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative. Patients need to use the FibriCheck application for a minimum of 3x/day and can perform extra measurements when symptoms are present.

Arms, Groups and Cohorts

• Experimental: Totally endoscopic cardiac surgery
  • Patients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative.

Clinical Trial Outcome Measures

Primary Measures

• The occurence of new-onset postoperative atrial fibrillation using constant electrocardiogram monitoring and photoplethysmography (FibriCheck)
  • Time Frame: Until 30 days postoperatively
  • New-onset postoperative atrial fibrillation will be detected until 30 days postoperatively. Constant electrocardiogram monitoring is performed at the intensive care unit (ICU). After dismissal from the ICU, the FibriCheck application is used to detect atrial fibrillation using photoplethysmography. Patients need to use the application three times a day and when symptoms are present.

Secondary Measures

• The effect of the closure of the pericardium on the development of new-onset postoperative atrial fibrillation
  • Time Frame: Intraoperative
  • It will be registered if the pericardium is closed unilateral, bilateral or left open.

Participating in This Clinical Trial

Inclusion Criteria

• >18 years old – Patients undergoing elective endoscopic cardiac surgery (totally endoscopic coronary artery bypass grafting or endoscopic valve replacement) Exclusion Criteria:

• Preoperative atrial fibrillation – Patients that do not understand Dutch or French or English – Patients that do not have a smartphone – Concomitant or redo surgeries

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Jessa Hospital
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Abdullah Kaya, MD, PhD, Principal Investigator, Jessa Hospital
• Overall Contact(s)
  • Abdullah Kaya, MD, PhD, 011 33 71 05, Abdullah.kaya@jessazh.be