Back to resultsThe Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery (AFMICS-II)
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
FibriCheck
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Postoperative atrial fibrillation, Minimally invasive cardiac surgery
Eligibility Criteria
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
Sites / Locations
- Jessa HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Totally endoscopic cardiac surgery
Arm Description
Patients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05633797
Brief Title
The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery
Acronym
AFMICS-II
Official Title
The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
July 2, 2024 (Anticipated)
Study Completion Date
August 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jessa Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate the occurrence of new-onset postoperative atrial fibrillation after totally endoscopic cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Postoperative atrial fibrillation, Minimally invasive cardiac surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Totally endoscopic cardiac surgery
Arm Type
Experimental
Arm Description
Patients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative.
Intervention Type
Device
Intervention Name(s)
FibriCheck
Intervention Description
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.
Primary Outcome Measure Information:
Title
The occurence of new-onset postoperative atrial fibrillation using constant electrocardiogram monitoring and photoplethysmography (FibriCheck)
Description
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.
Time Frame
Until 30 days postoperatively
Secondary Outcome Measure Information:
Title
The effect of the closure of the pericardium on the development of new-onset postoperative atrial fibrillation
Description
It will be registered if the pericardium is closed unilateral, bilateral or left open.
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah Kaya, MD, PhD
Phone
011 33 71 05
Email
Abdullah.kaya@jessazh.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jade Claessens, MSc
Phone
011 33 71 07
Email
jade.claessens@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah Kaya, MD, PhD
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
State/Province
Limburg
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Kaya, MD, PhD
Phone
+3211337105
Email
abdullah.kaya@jessazh.be
First Name & Middle Initial & Last Name & Degree
Jade Claessens, MsC
Phone
+3211337107
Email
jade.claessens@jessazh.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery
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