Atrial FibrillationSUSTAINERNCT06098664
Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
Atrial fibrillation (AF) initially starts in a paroxysmal form, which is mainly based on the presence of triggers. Progression of AF is accompanied by structural and electrical remodelling which can typically be described as a progressive change in electrophysiological properties of the myocardium caused by… 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?
- AI-enabled ECG score for Atrial Fibrillation (DNN score) and Atrial voltage map in sinus rhythm
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jun 2023to 1 Dec 2023
- Phase
- Observational
- 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
Study population: All patients scheduled for a PVI will be consecutively screened and enrolled in the study. The inclusions will be stratified to the DNN score.
Who may be able to join
- Provide signed and dated informed consent.
- First PVI-procedure
- Age is 18 years or higher.
- 12-lead ECG available in SR during the last 14 days.
Who cannot join
- Mitral insufficiency of grade 3 or 4.
- Participating in another study that may interfere with participation in this study
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Henri Gruwez, MD, +3289212051, henri.gruwez@zol.be
CTU Clinical Trial Unit, +3289212021, CTU@zol.be
About this study
Atrial fibrillation (AF) initially starts in a paroxysmal form, which is mainly based on the presence of triggers. Progression of AF is accompanied by structural and electrical remodelling which can typically be described as a progressive change in electrophysiological properties of the myocardium caused by cardiovascular comorbidities and AF itself. This results in complex electrical conduction disorders, which is defined as electropathology. The aim of our study is to evaluate whether an artificial intelligence (AI)-enabled ECG algorithm (on an ECG in Sinus Rhythm) can predict electropathology in patients with AF who undergo a first PVI.
- Conditions
- Atrial Fibrillation
- Being tested
- AI-enabled ECG score for Atrial Fibrillation (DNN score), Atrial voltage map in sinus rhythm
- Keywords
- Artificial Intelligence, Deep Neural Network, Electrocardiogram, Pulmonary Vein Isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enabled ECG score for Atrial Fibrillation (DNN score)Diagnostic test
A 12-lead ECG, performed within 24 hours before the Pulmonary Vein Isolation (PVI) procedure, will be used to calculate the DNN score.
(DNN score details: https://doi.org/10.1016/j.jacep.2023.04.008)
Atrial voltage map in sinus rhythmDiagnostic test
An atrial voltage map will be constructed prior to the PVI procedure.
| Study group | Role | What they receive |
|---|---|---|
| Low score group (DNN-score = 0 - 10%) | The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. Receives: Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score); Diagnostic Test: Atrial voltage map in sinus rhythm | |
| Medium score group (DNN-score = 10 - 50%) | The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. Receives: Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score); Diagnostic Test: Atrial voltage map in sinus rhythm | |
| High score group (DNN-score = 50 - 100%) | The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. Receives: Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score); Diagnostic Test: Atrial voltage map in sinus rhythm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low voltage area
Proportion of low voltage area in the left atrium. (Defined as a threshold 0.5mV)
Measured: During atrial voltage mapping, prior to PVI procedure.
Secondary outcomes (8)
Transition zone voltage area
Proportion of transition zone voltage area in the left atrium. (Defined as a threshold 1mV)
Measured: During atrial voltage mapping, prior to PVI procedure.
Conduction delay
Number of deceleration zones in the left atrium. (Deceleration zone defined as a zone with a conduction speed of <27cm/s)
Measured: During atrial voltage mapping, prior to PVI procedure.
Conduction delay score
Weighted score for conduction deceleration zones (taking in account the number of affected zones and the severity of conduction delay)
Measured: During atrial voltage mapping, prior to PVI procedure.
Conduction time from sinus node to Bachman bundle
Based on Local Activation Time (LAT) sampling. Defined as first point in right atrium to first point in left atrium.
Measured: During atrial voltage mapping, prior to PVI procedure.
Total LA conduction time
Based on LAT sampling
Measured: During atrial voltage mapping, prior to PVI procedure.
Left atrial appendage ejection velocity.
Measured with TEE pulsed wave doppler.
Measured: Immediately prior to PVI procedure.
Left atrial size
Measured on CT or MRI imaging
Measured: Prior to PVI procedure.
Pericardial adipose tissue volume
Measured on CT or MRI imaging
Measured: Prior to PVI procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start26 Jun 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent Pison, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098664
- Sponsor's protocol ID
- Z-2023039
- Acronym
- SUSTAINER
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 24 Oct 2023
- 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06098664
- Acronym / sponsor ID
- SUSTAINER / Z-2023039
- Conditions
- Atrial Fibrillation
- Keywords
- Artificial Intelligence, Deep Neural Network, Electrocardiogram, Pulmonary Vein Isolation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 24 Oct 2023 (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.
Atrial fibrillation (AF) initially starts in a paroxysmal form, which is mainly based on the presence of triggers. Progression of AF is accompanied by structural and electrical remodelling which can typically be described as a progressive change in electrophysiological properties of the myocardium caused by cardiovascular comorbidities and AF itself. This results in complex electrical conduction disorders, which is defined as electropathology. The aim of our study is to evaluate whether an artificial intelligence (AI)-enabled ECG algorithm (on an ECG in Sinus Rhythm) can predict electropathology in patients with AF who undergo a first PVI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low score group (DNN-score = 0 - 10%) | – | Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score), Diagnostic Test: Atrial voltage map in sinus rhythmThe inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. |
| Medium score group (DNN-score = 10 - 50%) | – | Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score), Diagnostic Test: Atrial voltage map in sinus rhythmThe inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. |
| High score group (DNN-score = 50 - 100%) | – | Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score), Diagnostic Test: Atrial voltage map in sinus rhythmThe inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for a PVI will be consecutively screened and enrolled in the study. The inclusions will be stratified to the DNN score.
Key inclusion criteria (4 listed)
- Provide signed and dated informed consent.
- First PVI-procedure
- Age is 18 years or higher.
- 12-lead ECG available in SR during the last 14 days.
Key exclusion criteria (2 listed)
- Mitral insufficiency of grade 3 or 4.
- Participating in another study that may interfere with participation in this study
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 |
|---|---|---|
| AI-enabled ECG score for Atrial Fibrillation (DNN score)A 12-lead ECG, performed within 24 hours before the Pulmonary Vein Isolation (PVI) procedure, will be used to calculate the DNN score. (DNN score details: https://doi.org/10.1016/j.jacep.2023.04.008) | Diagnostic test | High score group (DNN-score = 50 - 100%), Low score group (DNN-score = 0 - 10%), Medium score group (DNN-score = 10 - 50%) |
| Atrial voltage map in sinus rhythmAn atrial voltage map will be constructed prior to the PVI procedure. | Diagnostic test | High score group (DNN-score = 50 - 100%), Low score group (DNN-score = 0 - 10%), Medium score group (DNN-score = 10 - 50%) |
Primary outcome
Low voltage area
Time frame: During atrial voltage mapping, prior to PVI procedure.
Proportion of low voltage area in the left atrium. (Defined as a threshold 0.5mV)
8 secondary outcomes
Transition zone voltage area
Time frame: During atrial voltage mapping, prior to PVI procedure.
Conduction delay
Time frame: During atrial voltage mapping, prior to PVI procedure.
Conduction delay score
Time frame: During atrial voltage mapping, prior to PVI procedure.
Conduction time from sinus node to Bachman bundle
Time frame: During atrial voltage mapping, prior to PVI procedure.
Total LA conduction time
Time frame: During atrial voltage mapping, prior to PVI procedure.
Left atrial appendage ejection velocity.
Time frame: Immediately prior to PVI procedure.
Left atrial size
Time frame: Prior to PVI procedure.
Pericardial adipose tissue volume
Time frame: Prior to PVI procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Ziekenhuis Oost-Limburg 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 2 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: status not confirmed, as of the sponsor's last update on 24 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henri M.P.B.C. Gruwez, MD (+3289212051, henri.gruwez@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low voltage area (time frame: During atrial voltage mapping, prior to PVI procedure.). 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 24 Oct 2023.