Atrial FibrillationAFMICS-IINCT05633797
The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery
A study testing FibriCheck in people with Atrial Fibrillation, run by Jessa Hospital at 1 site in Belgium.
Trial summary
The aim of this study is to investigate the occurrence of new-onset postoperative atrial fibrillation after totally endoscopic cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- FibriCheck
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Mar 2023to 9 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- Patients undergoing elective endoscopic cardiac surgery (totally endoscopic coronary artery bypass grafting or endoscopic valve replacement)
Who cannot join
- Preoperative atrial fibrillation
- Patients that do not understand Dutch or French or English
- Patients that do not have a smartphone
- Concomitant or redo surgeries
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the occurrence of new-onset postoperative atrial fibrillation after totally endoscopic cardiac surgery.
- Conditions
- Atrial Fibrillation
- Being tested
- FibriCheck
- Keywords
- Postoperative atrial fibrillation, Minimally invasive cardiac surgery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibriCheckDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Totally endoscopic cardiac surgery | Experimental | Patients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative. Receives: Device: FibriCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until 30 days postoperatively
Secondary outcomes (1)
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.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start22 Mar 2023
- Primary completion9 Nov 2024
- Study completion9 Nov 2024
Why it stopped: After the passing of the principal investigator, the clinical trial could not be continued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaaddin Yilmaz, MD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633797
- Sponsor's protocol ID
- f/2022/127
- Acronym
- AFMICS-II
- Status last verified
- May 2024
- First submitted
- 18 Nov 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05633797
- Acronym / sponsor ID
- AFMICS-II / f/2022/127
- Conditions
- Atrial Fibrillation
- Keywords
- Postoperative atrial fibrillation, Minimally invasive cardiac surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After the passing of the principal investigator, the clinical trial could not be continued.
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- 9 Nov 2024 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the occurrence of new-onset postoperative atrial fibrillation after totally endoscopic cardiac surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Totally endoscopic cardiac surgery | Experimental | Device: FibriCheckPatients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years old
- Patients undergoing elective endoscopic cardiac surgery (totally endoscopic coronary artery bypass grafting or endoscopic valve replacement)
Key exclusion criteria (4 listed)
- Preoperative atrial fibrillation
- Patients that do not understand Dutch or French or English
- Patients that do not have a smartphone
- Concomitant or redo surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibriCheckDuring 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. | Device | Totally endoscopic cardiac surgery |
Primary outcome
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.
1 secondary outcome
The effect of the closure of the pericardium on the development of new-onset postoperative atrial fibrillation
Time frame: Intraoperative
Results and safety
The study was stopped early (reason given: After the passing of the principal investigator, the clinical trial could not be continued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaaddin Yilmaz, MD principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibriCheck in people with Atrial Fibrillation, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: After the passing of the principal investigator, the clinical trial could not be continued.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurence of new-onset postoperative atrial fibrillation using constant electrocardiogram monitoring and photoplethysmography (FibriCheck) (time frame: Until 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.