The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery (AFMICS-II)

November 26, 2024 updated by: Jessa Hospital
The aim of this study is to investigate the occurrence of new-onset postoperative atrial fibrillation after totally endoscopic cardiac surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Hasselt, Limburg, Belgium
        • Jessa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Totally endoscopic cardiac surgery
Patients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until 30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessa Hospital

Investigators

  • Principal Investigator: Alaaddin Yilmaz, MD, Jessa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2023

Primary Completion (Actual)

November 9, 2024

Study Completion (Actual)

November 9, 2024

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • f/2022/127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on FibriCheck

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe