Atrial Fibrillation and FlutterSURGICAL-AF 2NCT05509517
A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery
A study testing Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™) in people with Atrial Fibrillation and Flutter and Atrial Fibrillation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The objective of the study is to evaluate the clinical consequences following the detection of postoperative atrial fibrillation or flutter (POAF) using a remote heart rhythm monitoring strategy with a photoplethysmography based smartphone technology in the early postoperative period after discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation and Flutter, Atrial Fibrillation, Postoperative Complications
- What is being tested?
- Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Nov 2021to 4 Sep 2023
- 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
- Subject underwent any of (including a combination of) the following surgical procedures during index hospitalization. (coronary artery bypass graft, surgical repair or replacement of a cardiac valve)
- Subject provides informed consent
- Subject understands and agrees to comply with planned study procedures.
- Subject is able to perform heart rhythm measurement using the FibriCheck application at home.
Who cannot join
- Pacemaker dependent heart rhythm
- Permanent AF/Aflutter or AF/Aflutter present at the time of inclusion
- Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
- No smartphone available at home.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Heart Rhythm Monitoring Using Photoplethysmography-based Smartphone Technology for the Early Detection of Atrial Fibrillation and Adverse Events After Cardiac Surgery
The objective of the study is to evaluate the clinical consequences following the detection of postoperative atrial fibrillation or flutter (POAF) using a remote heart rhythm monitoring strategy with a photoplethysmography based smartphone technology in the early postoperative period after discharge.
Read the detailed description
A predefined subgroup analysis of the outcomes described below will be performed in the following subgroups:
- Subjects not on anticoagulation drug therapy (for a planned duration of >45 days) at discharge.
- Subjects with no history of AF prior to surgery and no POAF lasting >24h in hospital.
- Subjects with a CHADSVASC score ≥ 4 or a CHADSVASC score ≥ 2 with at least one additional risk factor associated with the risk of developing POAF. additional risk factors include:
- chronic obstructive pulmonary disease
- sleep apnea
- impaired renal function
- left atrial enlargement
- elevated body mass index
- combined CABG with valve repair or replacement
- Conditions
- Atrial Fibrillation and Flutter, Atrial Fibrillation, Postoperative Complications, Arrhythmia
- Being tested
- Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)
- Keywords
- Atrial Fibrillation, Digital Health, Artificial Intelligence, Cardiac Surgery, Postoperative atrial fibrillation (POAF)
- Medical subject headings
- Atrial Fibrillation, Postoperative Complications, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)Diagnostic test
Heart Rhythm assessment using the FibriCheck™ application with the patient's proprietary smartphone, three times daily, from discharge until follow-up consultation (day 21-91 after discharge).
| Study group | Role | What they receive |
|---|---|---|
| Rhythm monitoring group | Experimental | Patients randomized to the rhythm monitoring arm will assess their heart rhythm with a photoplethismography (PPG) based smartphone application (FibriCheck™). Measurements are performed three times daily and while experiencing symptoms. The patients start measuring immediately after discharge and continues until the scheduled postoperative consultation with the cardiologist or cardiac surgeon at 21-91days after discharge. Receives: Diagnostic Test: Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™) |
| Usual care | No intervention | Patients randomized to the rhythm monitoring arm will be discharged without protocol mandated rhythm monitoring. A postoperative consultation is scheduled with the cardiologist or cardiac surgeon at 21-91days after discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint)
Any of the following therapeutic interventions:
- Initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection
- Initiation or increase in dose regimen of anti-arrhythmic drug therapy (Vaughan-williams class 1 or 3)
- Cardioversion
- Cardiac implantable electronic device (CIED) implantation
Measured: 91 days
Time to detection of a postoperative adverse event
Prespecified postoperative adverse events:
1.1. Acute respiratory insufficiency 1.2. Pleural effusion 1.3. Pneumonia 1.4. Pulmonary Embolism 1.5. Pneumothorax 1.6. Atelectasis, leading to respiratory insufficiency
2.1. Acute myocardial infarction 2.2. Symptomatic arrhythmia 2.3. Pericardial effusion 2.4. Pericarditis 2.5. Endocarditis 2.6. Systemic embolism 2.7. Cardiogenic shock
3.1. Acute stoke including cerebrovascular accident (CVA) and transient ischemic attack (TIA)
4.1. Renal failure, defined as: >50% increase in serum creatinine or initiation of renal replacement therapy 4.2. Urinary tract infection, requiring antibiotic treatment
- Wound related complications requiring surgical intervention or antibiotic treatment.
- Sepsis
- Other unplanned hospitalisations will be classified by the research team as 'postoperative adverse event' or 'unrelated to the cardiac surgery procedure'. Such events will be reported with the study results.
Measured: 91 days
Secondary outcomes (9)
Time to primary endpoint (primary outcome 1)
Measured: 91 days
Proportion of participants with initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection
Measured: 91 days
Post-operative atrial fibrillation (POAF) detection rate
Measured: 91 days
Time to POAF detection
Measured: 91 days
POAF detection rate in subjects with an indication for anticoagulation
Measured: 91 days
Detection rate of POAF lasting more than 6 hours
Measured: 91 days
The EQ-5D-5L questionnaire score evolution between inclusion and follow-up consultation
EQ-5D-5L is a EuroQol five-dimension scale questionnaire. The participant rates his or her own level of impairment across dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) from 1 to 5 and global health rating on a visual analogue scale (EQ-VAS) from 1 to 100.
Measured: 91 days
Number of mayor adverse cardiac outcomes (All-cause death, Ischemic stroke, Myocardial infarction, Systemic embolism)
Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)
Measured: Two years
Number of mayor adverse cardiac outcomes (secondary outcome 9) with addition of cardiovascular hospitalisations
Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start2 Nov 2021
- Primary completion5 Jul 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation and FlutterStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509517
- Sponsor's protocol ID
- S64572
- Acronym
- SURGICAL-AF 2
- Status last verified
- Nov 2022
- First submitted
- 12 Jul 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Heart Rhythm Monitoring Using Photoplethysmography-based Smartphone Technology for the Early Detection of Atrial Fibrillation and Adverse Events After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05509517
- Acronym / sponsor ID
- SURGICAL-AF 2 / S64572
- Conditions
- Atrial Fibrillation and Flutter, Atrial Fibrillation, Postoperative Complications, Arrhythmia
- Keywords
- Atrial Fibrillation, Digital Health, Artificial Intelligence, Cardiac Surgery, Postoperative atrial fibrillation (POAF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 22 Aug 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 objective of the study is to evaluate the clinical consequences following the detection of postoperative atrial fibrillation or flutter (POAF) using a remote heart rhythm monitoring strategy with a photoplethysmography based smartphone technology in the early postoperative period after discharge.
Detailed description
A predefined subgroup analysis of the outcomes described below will be performed in the following subgroups:
- Subjects not on anticoagulation drug therapy (for a planned duration of >45 days) at discharge.
- Subjects with no history of AF prior to surgery and no POAF lasting >24h in hospital.
- Subjects with a CHADSVASC score ≥ 4 or a CHADSVASC score ≥ 2 with at least one additional risk factor associated with the risk of developing POAF. additional risk factors include:
- chronic obstructive pulmonary disease
- sleep apnea
- impaired renal function
- left atrial enlargement
- elevated body mass index
- combined CABG with valve repair or replacement
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythm monitoring group | Experimental | Diagnostic Test: Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)Patients randomized to the rhythm monitoring arm will assess their heart rhythm with a photoplethismography (PPG) based smartphone application (FibriCheck™). Measurements are performed three times daily and while experiencing symptoms. The patients start measuring immediately after discharge and continues until the scheduled postoperative consultation with the cardiologist or cardiac surgeon at 21-91days after discharge. |
| Usual care | No intervention | –Patients randomized to the rhythm monitoring arm will be discharged without protocol mandated rhythm monitoring. A postoperative consultation is scheduled with the cardiologist or cardiac surgeon at 21-91days after discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject underwent any of (including a combination of) the following surgical procedures during index hospitalization. (coronary artery bypass graft, surgical repair or replacement of a cardiac valve)
- Subject provides informed consent
- Subject understands and agrees to comply with planned study procedures.
- Subject is able to perform heart rhythm measurement using the FibriCheck application at home.
Key exclusion criteria (4 listed)
- Pacemaker dependent heart rhythm
- Permanent AF/Aflutter or AF/Aflutter present at the time of inclusion
- Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
- No smartphone available at home.
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 |
|---|---|---|
| Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)Heart Rhythm assessment using the FibriCheck™ application with the patient's proprietary smartphone, three times daily, from discharge until follow-up consultation (day 21-91 after discharge). | Diagnostic test | Rhythm monitoring group |
Primary outcome
Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint)
Time frame: 91 days
Any of the following therapeutic interventions: * Initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection * Initiation or increase in dose regimen of anti-arrhythmic drug therapy (Vaughan-williams class 1 or 3) * Cardioversion * Cardiac implantable electronic device (CIED) implantation
Time to detection of a postoperative adverse event
Time frame: 91 days
Prespecified postoperative adverse events: 1.1. Acute respiratory insufficiency 1.2. Pleural effusion 1.3. Pneumonia 1.4. Pulmonary Embolism 1.5. Pneumothorax 1.6. Atelectasis, leading to respiratory insufficiency 2.1. Acute myocardial infarction 2.2. Symptomatic arrhythmia 2.3. Pericardial effusion 2.4. Pericarditis 2.5. Endocarditis 2.6. Systemic embolism 2.7. Cardiogenic shock 3.1. Acute stoke including cerebrovascular accident (CVA) and transient ischemic attack (TIA) 4.1. Renal failure, defined as: >50% increase in serum creatinine or initiation of renal replacement therapy 4.2. Urinary tract infection, requiring antibiotic treatment 5. Wound related complications requiring surgical intervention or antibiotic treatment. 6. Sepsis 7. Other unplanned hospitalisations will be classified by the research team as 'postoperative adverse event' or 'unrelated to the cardiac surgery procedure'. Such events will be reported with the study results.
9 secondary outcomes
Time to primary endpoint (primary outcome 1)
Time frame: 91 days
Proportion of participants with initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection
Time frame: 91 days
Post-operative atrial fibrillation (POAF) detection rate
Time frame: 91 days
Time to POAF detection
Time frame: 91 days
POAF detection rate in subjects with an indication for anticoagulation
Time frame: 91 days
Detection rate of POAF lasting more than 6 hours
Time frame: 91 days
The EQ-5D-5L questionnaire score evolution between inclusion and follow-up consultation
Time frame: 91 days
Number of mayor adverse cardiac outcomes (All-cause death, Ischemic stroke, Myocardial infarction, Systemic embolism)
Time frame: Two years
Number of mayor adverse cardiac outcomes (secondary outcome 9) with addition of cardiovascular hospitalisations
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™) in people with Atrial Fibrillation and Flutter and Atrial Fibrillation, run by Universitaire Ziekenhuizen KU Leuven 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 4 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: finished, as of the sponsor's last update on 30 Nov 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint) (time frame: 91 days). The study lists 2 primary outcomes in all. 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 30 Nov 2023.