The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery

NCT05633797 | Terminated

• 1 other identifier: f/2022/127
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Postoperative atrial fibrillation; Minimally invasive cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The effect of the closure of the pericardium on the development of new-onset postoperative atrial fibrillation

  Intraoperative

Study Arms (1)

Totally endoscopic cardiac surgery

EXPERIMENTAL

Patients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative.

Device: FibriCheck

Interventions

FibriCheck DEVICE

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.

Totally endoscopic cardiac surgery

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Alaaddin Yilmaz, MD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 1, 2022
• Study Start: March 22, 2023
• Primary Completion: November 9, 2024
• Study Completion: November 9, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)