The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery

Atrial Fibrillation Clinical Trial

— AFMICS-II  

Official title:

The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633797
• Other study ID #: f/2022/127
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: August 2, 2024

Study information

• Verified date: May 2024
• Source: Jessa Hospital
• Contact: Alaaddin Yilmaz, MD
• Phone: 011 33 71 04
• Email: alaaddin.yilmaz[@]jessazh.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2, 2024
• Est. primary completion date: July 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurence of new-onset postoperative atrial fibrillation using constant electrocardiogram monitoring and photoplethysmography (FibriCheck)	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.	Until 30 days postoperatively
Secondary	The effect of the closure of the pericardium on the development of new-onset postoperative atrial fibrillation	It will be registered if the pericardium is closed unilateral, bilateral or left open.	Intraoperative