Multimodal Cardiac Imaging Registry in Patients with Atrial Fibrillation
NCT ID: NCT06584266
Last Updated: 2024-09-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
3000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-01-01
Study Completion Date
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The goal of this observational registry is to collect a curated dataset of multimodal imaging data that will serve for development of artificial-intelligence based solutions for prediction of risk and outcomes in patients with atrial fribrillation.
Type of study: observational study
Study Participants: Patients with atrial fibrillation or atrial flutter who undergo clinically indicated transesophageal echocardiography before catheter ablation or cardioversion.
We hypothesize, that automatic analysis of video images of transthoracic echocardiography with deep learning combined with clinical data can predict the presence of left atrial appendage thrombus (LAT). Therefore, our main aim is to create and validate an artificial intelligence model to predict the presence of LAT based on automatic analysis of transthoracic echocardiography with artificial intelligence.
Type of study: observational study
Study Participants: Patients with atrial fibrillation or atrial flutter who undergo clinically indicated transesophageal echocardiography before catheter ablation or cardioversion.
We hypothesize, that automatic analysis of video images of transthoracic echocardiography with deep learning combined with clinical data can predict the presence of left atrial appendage thrombus (LAT). Therefore, our main aim is to create and validate an artificial intelligence model to predict the presence of LAT based on automatic analysis of transthoracic echocardiography with artificial intelligence.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Predicting Disease Progression in Atrial Fibrillation: A Multiparametric Approach for Prognostic Marker Identification and Personalized Patient Management
NCT06647914
Atrial Fibrillation (AF)
NOT_YET_RECRUITING
First-line Treatment for Atrial Fibrillation in Cardiology and Geriatric Departments
NCT02884661
Atrial Fibrillation
COMPLETED
First-time Ablation of Atrial Fibrillation Registry
NCT06381245
Atrial Fibrillation
Arrhythmia
RECRUITING
Comparison of Different Electroporation Systems in the Ablation Treatment of Atrial Fibrillation
NCT06646887
AF
Ablation of Atrial Fibrillation
ACTIVE_NOT_RECRUITING
NA
AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation
NCT05481359
Atrial Fibrillation, Persistent
Atrial Fibrillation
Arrhythmias, Cardiac
+1 more
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Introduction
Atrial fibrillation (AF) is the most common cardiac arrythmia, that affects 37% Europeans over 55 years old, representing a major burden for the society and health systems. One of the most devastating consequences of AF is ischemic stroke, often caused by embolization of cerebral arteries with a left atrial appendage thrombus (LAT), which can form in left atrial appendage in the presence of AF. As it has little contractility on its own, emptying and filling of left atrial appendage relies on the function of the left ventricle and the left atrium.
AF as well as atrial flutter promote the formation of LAT and are therefore associated with an increased risk of thromboembolic events. The mechanism of stroke is complex, but embolization with LAT accounts for the majority of events and it can be triggered by sinus rhythm restoration through procedures commonly performed in patients with AF - cardioversion or catheter ablation. Therefore, cardioversion and catheter ablation in the presence of LAT are contraindicated.
Transoesophageal echocardiography (TEE) is considered the modality of choice to detect LAT with high sensitivity and specificity and is currently recommended before cardioversion or catheter ablation as an alternative to a 3-week course of oral anticoagulation. Current guidelines, however, leave room for an individual decision to either perform or not perform TEE before catheter ablation or cardioversion in a chronically anticoagulated patient but suggest no tools to assess the risk of LAT. To address this unmet clinical need, we have previously shown that by combining clinical data and measurements from transthoracic echocardiography in a machine-learning model it is possible to predict the risk of LAT formation. Importantly, our results indicated, that TTE-derived measurements played the greatest role in predicting LAT.
Despite significant advancements in interventional technologies, the selection of appropriate therapeutic methods and perioperative procedures remains a significant challenge. Patients eligible for interventional procedures related to AF often undergo numerous diagnostic tests, including computed tomography of the heart, transoesophageal and transthoracic echocardiography, electrocardiography (EKG), and electroanatomic mapping during the ablation procedure. Non-invasive multimodal imaging plays central role in the peri-ablation period, informing important therapeutic decisions and facilitating the procedure. The essence of this project is the prospective collection of high-quality imaging data from these multiple modalities and clinical data, which will allow for a better understanding of the relationships between anatomy, hemodynamic function, and clinical observation in patients with AF in the future. Ultimately the data might serve for the development of tools which could efficiently predict the risk of LAT by means of less invasive and cheaper approaches than the ones which are currently used. The resulting multimodal database will also form a foundation for future studies targeted at informing therapeutic decisions in patients undergoing catheter ablation of AF.
2. Study Objectives
2.1. Main objective: To create a multimodal, multicentre registry of clinical and imaging data to develop predictive models based on state-of the art artificial intelligence to support the diagnostic and therapeutic process for patients undergoing AF catheter ablation and cardioversion.
2.2. Specific objectives:
2.2.1. Specific Aim 1 Creation of artificial intelligence-based models to predict the risk of formation of left atrial appendage thrombus and estimate the left atrial appendage emptying velocity obtained from transoesophageal echocardiography based on the analysis of transthoracic echocardiographic images and clinical data.
2.2.2. Specific Aim 2 Assessment of inter-reader and intra-reader agreement in the clinical interpretation of left atrial appendage images and left atrial appendage thrombus diagnosis in transoesophageal echocardiography.
2.2.3. Specific Aim 3 Development of models that fuse information from multiple modalities (for instance from transthoracic echocardiography and cardiac CT) to provide better prognosis and guide therapeutic decisions in patients with atrial fibrillation.
2.2.4. Specific Aim 4 Comparison of the effectiveness of different methods of imaging the left atrium in predicting thromboembolic events.
2.2.5. Specific Aim 5 Creation of a high-quality multicentre imaging database for additional future auxillary nalyses and studies.
3. Study Methodology
To maximize the amount of collected data the study allows both retrospective and prospective data collection. The scope of collected data is the same in retrospective and prospective collection with certain data types being optional and subject to availability.
3.1. Inclusion criteria
Patients with:
* history of atrial fibrillation,
* who are undergoing medically justified transoesophageal echocardiography to assess the presence of left atrial appendage thrombus before catheter ablation of atrial fibrillation (including patients who had transoesophageal echocardiography during the ablation procedure). OR
* who undergo catheter ablation without prior transoesophageal echocardiography (if the center also collects additional imaging data listed in point 2.5 below) 3.2. Exclusion criteria
* Age \< 18 years old.
3.3 3.3. Types of collected data
Data type: Clinical data Compulsory or optional: Includes compulsory and optional fields Format: Tabular, collected using a dedicated eCRF Additional remarks: The detailed list of fields with possible values is shown in Appendix 1
Data type: TTE Compulsory or optional: Compulsory Format: DICOM Additional remarks: Recorded before TEE preferably on the same day. In case of retrospective data TTE and TEE acquired within 72h
Data type: TEE Compulsory or optional: Compulsory if the patient had TEE Format: DICOM
Additional remarks:
Data type: Cardiac CT Compulsory or optional: Optional Format: DICOM Additional remarks: Contrast enhanced cardiac CT before ablation procedure. Can be a study performed for EP planning or for CAD diagnostics. Any study performed before the ablation regardless of timing can be used
Data type: Non-contrast Cardiac CT Compulsory or optional: Optional Format: DICOM Additional remarks: Non-contrast chest CT. Preferred is ECG-gated calcium scoring CT reconstructed with thin slices (preferably 0.5mm).
Data type: Cardiac Magnetic Resonance (CMR) Compulsory or optional: Optional Format: DICOM
Additional remarks:
Data type: Digitalised Electrocardiogram Compulsory or optional: Optional Format: DICOM (or pdf) Additional remarks: Performed on the day of the catheter ablation or cardioversion or day before.
Data type: Electroanatomical map Compulsory or optional: Optional Format: Proprietary Additional remarks: Not to be transferred but only stored locally in the participating center for possible ancillary studies
Data type: Follow-up for MACE Compulsory or optional: Optional Format: Event date Additional remarks: Depending on the local regulations and possibility, the follow-up data for all-cause mortality, stroke, myocardial infarction, onset or worsening of heart failure will be obtained based on ICD-9 and ICD 10 codes from the national health insurance databases. Alternatively, data can be obtained by telephone interview
Data type: Follow-up for AF Compulsory or optional: Optional Format: Event date Additional remarks: Depending on the local availability of follow-up data for AF recurrence
3.4. Guidelines for data acquisition
3.4.1. Guidelines for Acquisition of Transthoracic and Transesophageal Echocardiography
* For prospective collection the TEE and TEE should be performed ideally in the same day, TTE directly before TEE. For the retrospective cohort TTE can be acquired up to 3 days before TEE, as long as there were no important changes in patients' condition during this period (i.e. clinical worsening, change of rhythm, heart rate etc).
* ECG electrodes should be connected for both TTE and TEE (not compulsory for retrospective data)
* The acquisition length should be set to 5 seconds (set the start acquisition at the moment when acquire button is pressed to minimise unwanted movement). For retrospective data shorter clips are acceptable.
3.4.1.1. Acquisition of TTE \[filenames are given in brackets\]:
1. Four-chamber apical projection \[4ch.dcm\]
2. Two-chamber apical projection \[2ch.dcm\]
3. Three-chamber apical projection \[3ch.dcm\]
4. Four-chamber apical projection - optimized for LA \[4chLA.dcm\]
5. Two-chamber apical projection - optimized for LA \[2chLA.dcm\]
6. 3D full volume (preferably acquired from 4 or more heart cycles) \[3d\_tte.dcm\] The projections must encompass the entire heart, including the atria. Measurements to be performed at site (if impossible, some of these measurements can also be performed by the coordinating site).
<!-- -->
1. Cardiac chamber dimensions (PLAX) \[plax.dcm\]
2. Velocities E, A, med. E\', lat. E\' (still images) \[mitral\_flow.dcm, medial\_tdi.dcm, lateral\_tdi.dcm\]
3. Tricupid regurgitation spectral image (still images) \[tr.dcm\]
3.4.1.2. Acquisition of TEE:
1. Projection on LAA (Left Atrial Appendage): 0, 45, 90, 135 degrees, and other projections that are necessary to correctly image the entire LAA according to the investigator/ echocardiographer \[laa\_0.dcm, laa\_45.dcm, laa\_135.dcm etc.\]
2. 3D acquisition of the volume that contains LAA (multi-beat-optimized) \[3d\_LAA.dcm\]
3. Measurement of maximum emptying velocity of LAA 1cm from the LAA ostium - at least three measurements in two different scanning angles, averaged.
4. Acquisition of spectral Doppler image of LAA emptying (three images from two or more scanning angles) (still images) \[laav\_60.dcm, laav135.dcm, laav\_45.dcm\]
3.4.1.3. Other modalities: There are no specific acquisition requirements for cardiac CT, CMR or ECG - these studies should be performed according to local standard protocols.
Appendix 1 - Dictionary of tabular data
Variable: CaseID Display name: Case ID Type: ID Compulsory: Yes Categories and Units details: Consecutive IDs unique for each entry
Variable: PatientID Display name: Patient ID Type: ID Compulsory: Yes Categories and Units details: Consecutive ID for patients; if the patient is entered to the registry more than once, he/she should have the same PatientID
Variable: procedure\_type Display name: Type of planned intervention Type: Clinical Compulsory: Yes Categories and Units details: ablation = 1, cardioversion = 2, NA = 3, laa\_closure = 4, valvular disease = 5, infective endocarditis = 6
Variable: AF Display name: Atrial fibrillation Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: AFL Display name: Atrial flutter Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: arrythmia\_duration Display name: Paroxysmal, persistent, or long-standing Type: Clinical Compulsory: Yes Categories and Units details: persistent = 1, paroxysmal = 2, long-standing persistent = 3, NA = 4
Variable: Persistent\_arrythmia\_time Display name: Time since the onset of persistent arrythmia Type: Clinical Compulsory: Yes Categories and Units details: Time in months or days. Enter 0 for paroxysmal arrythmia
Variable: Persistent\_arrythmia\_time\_unit Display name: Months or days Type: Clinical Compulsory: Yes Categories and Units details: Months = 0, Days = 1
Variable: Disease\_duration Display name: Duration of AF Disease Type: Clinical Compulsory: Yes Categories and Units details: Time (approximate) since the first diagnosis of atrial fibrillation
Variable: Disease\_duration\_unit Display name: Months or Years Type: Clinical Compulsory: Yes Categories and Units details: Months = 0, Years = 1
Variable: EHRA Display name: EHRA scale Type: Clinical Compulsory: Yes Categories and Units details: I = 1, IIa = 2, IIb = 3, III = 4, IV = 5, NA = 6
Variable: Age Display name: Age Type: Clinical Compulsory: Yes Categories and Units details: Age in years
Variable: Sex Display name: Sex Type: Clinical Compulsory: Yes Categories and Units details: Male = 1, Female = 2
Variable: Height Display name: Height Type: Clinical Compulsory: Yes Categories and Units details: Height in cm
Variable: Weight Display name: Weight Type: Clinical Compulsory: Yes Categories and Units details: Weight in kg
Variable: HF\_status Display name: Heart failure Type: Clinical Compulsory: Yes Categories and Units details: HFmrEF= 1, HFpEF = 2, HFrEF = 3, No HF = 4
Variable: NYHA Display name: NYHA scale Type: Clinical Compulsory: Yes Categories and Units details: I = 0, II = 1, III = 2, IV = 3, No HF = 4
Variable: MS Display name: Mitral stenosis Type: Clinical Compulsory: Yes Categories and Units details: mild = 1, moderate = 2, severe = 3, no MS = 4
Variable: MR Display name: Mitral regurgitation Type: Clinical Compulsory: Yes Categories and Units details: mild = 1, moderate = 2, severe = 3, no MR = 4
Variable: AS Display name: Aortic stenosis Type: Clinical Compulsory: Yes Categories and Units details: mild = 1, moderate = 2, severe = 3, no AS = 4
Variable: AR Display name: Aortic regurgitation Type: Clinical Compulsory: Yes Categories and Units details: mild = 1, moderate = 2, severe = 3, no AR = 4
Variable: mitral\_valve\_replacement Display name: Mitral valve replacement Type: Clinical Compulsory: Yes Categories and Units details: biological = 1, mechanical = 2, No MVR = 3
Variable: aortic\_valve\_replacement Display name: Aortic valve replacement Type: Clinical Compulsory: Yes Categories and Units details: biological = 1, mechanical = 2, No AVR = 3
Variable: Implanatable\_device Display name: Presence of implantable electronic device Type: Clinical Compulsory: Yes Categories and Units details: None = 0, pacemaker = 1, ICD = 2, CRT-D = 3, CRT-P = 4, Implantable Recorder = 5, S-ICD = 6, Leadless pacemaker = 7
Variable: stroke\_type Display name: History of stroke Type: Clinical Compulsory: Yes Categories and Units details: haemorrhagic stroke = 1, ischaemic stroke = 2, both = 3, no history of stroke = 4
Variable: peripheral\_embolus Display name: History of peripheral embolism Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: revasc Display name: Prior revascularisation Type: Clinical Compulsory: Yes Categories and Units details: CABG = 1, No history of revasc = 2, PCI = 3, PCI+CABG = 4
Variable: cad Display name: Coronary Artery Disease Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: vascular\_disease Display name: Vascular disease Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: past\_bleeding Display name: History of bleeding Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: CKD Display name: Chronic kidney disease Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: HT Display name: Hypertension Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: DM Display name: Diabetes Mellitus Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: liver\_disease Display name: Liver disease Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: labile\_INR Display name: Labile INR Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: alcohol Display name: Alcohol abuse Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: smoking Display name: Smoking Type: Clinical Compulsory: Yes Categories and Units details: currently = 1, in the past = 2, non-smoker = 3
Variable: malignant\_tumor Display name: Malignant tumor or cancer Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0, Malignant tumor or cancer or hematologic malignant disease
Variable: COPD Display name: Chronic obstructive pulmonary disease Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: asthma Display name: Asthma Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: hyperthyroidism Display name: Hyperthyroidism Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: hypothyroidism Display name: Hypothyroidism Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: LA\_dimension Display name: Left atrial AP dimension Type: TTE Compulsory: Yes Categories and Units details: Value in mm
Variable: LVDd Display name: Left ventricular internal diameter end diastole Type: TTE Compulsory: Yes Categories and Units details: Value in mm
Variable: RVDd Display name: Right ventricular internal diameter end diastole Type: TTE Compulsory: Yes Categories and Units details: Value in mm
Variable: EF\_TTE Display name: Left Ventricular Ejection Fraction Type: TTE Compulsory: Yes Categories and Units details: Value in %
Variable: LA\_area\_4ch Display name: Left atrial area in four-chamber view Type: TTE Compulsory: Yes Categories and Units details: Value in cm2
Variable: LA\_length\_4ch Display name: Left atrial length in four-chamber view Type: TTE Compulsory: No Categories and Units details: Value in cm
Variable: LA\_area\_2ch Display name: Left atrial area in two-chamber view Type: TTE Compulsory: No Categories and Units details: Value in cm2
Variable: LA\_length\_2ch Display name: Left atrial length in two-chamber view Type: TTE Compulsory: No Categories and Units details: Value in cm
Variable: LA\_volume\_sp Display name: Left atrial single-plane volume Type: TTE Compulsory: No Categories and Units details: Value in cm3
Variable: LA\_volume Display name: Left atrial biplane volume Type: TTE Compulsory: No Categories and Units details: Value in cm3
Variable: LAVI Display name: Left atrial volume index Type: TTE Compulsory: No Categories and Units details: Value in cm3/m2
Variable: E Display name: Peak E-wave velocity Type: TTE Compulsory: Yes Categories and Units details: Value in cm/s
Variable: A Display name: Peak A-wave velocity Type: TTE Compulsory: Yes Categories and Units details: Value in cm/s
Variable: Med\_Eprim Display name: Med E\' - Early diastolic medial mitral annulus velocity Type: TTE Compulsory: Yes Categories and Units details: Value in cm/s
Variable: Lat\_Eprim Display name: Lat E\' - Early diastolic lateral mitral annulus velocity Type: TTE Compulsory: Yes Categories and Units details: Value in cm/s
Variable: RA area Display name: Right atrial area Type: TTE Compulsory: No Categories and Units details: Value in cm2
Variable: Act Display name: Pulmonary acceleration time Type: TTE Compulsory: Yes Categories and Units details: Value in ms
Variable: lab\_date Display name: Lab Test Date Type: Lab Tests Compulsory: No Categories and Units details: If blood sample was drawn during hospitalization and lab test results are entered, please provide the date of lab tests
Variable: BNP Display name: NT-proBNP Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: Fib Display name: Fibrynogen Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: CRP Display name: C-reactive Protein Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: APTT Display name: Activated partial Thromboplastin Time Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: INR Display name: International Normalized Ratio Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: Hb Display name: Hemoglobin Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: RDW Display name: Red Cell Distribution Width Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: Crea Display name: Creatinine Type: Lab Tests Compulsory: No Categories and Units details: mg/dl
Variable: months\_anticoagulation Display name: Months since initiation of anticoagulation Type: Medication Compulsory: Yes Categories and Units details: Time in months; if more than one year, enter 12
Variable: days\_anticoagulation Display name: Days since initiation of anticoagulation Type: Medication Compulsory: Yes Categories and Units details: (if \<1 month, otherwise leave blank)
Variable: anticoagulant Display name: Type of anticoagulant medication Type: Medication Compulsory: Yes Categories and Units details: apixaban\_2x5 = 1, rivaroxaban\_20 = 2, dabigatran\_2x150 = 3, acenocumarol = 4, warfarin = 5, apixaban\_2x2.5 = 6, rivaroxaban\_15 = 7, dabigatran\_2x110 = 8, LVH = 9, HNF = 10, no anticoagulation = 11
Variable: days\_dabigatran\_temp\_use Display name: Temporary use of dabigatran (days) Type: Medication Compulsory: Yes Categories and Units details: Explanation: This is perhaps site-specific. In our center, we change medication to dabigatran in the periprocedural period because of access to praxbind.
Variable: ASA Display name: intake of acetylsalicylic acid Type: Medication Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: clopidogrel Display name: intake of clopidogrel Type: Medication Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: tikagrelor Display name: intake of tikagrelor Type: Medication Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: prasugrel Display name: intake of prasugrel Type: Medication Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: base\_rythm Display name: Rhythm at the time of study Type: Clinical Compulsory: Yes Categories and Units details: SR = 1, AF = 1, Afl = 2
Variable: TEE\_in\_cath\_lab Display name: TEE performed in cath lab Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0; indicates if TEE was performed during the ablation procedure
Variable: TEE\_historyof\_LAT Display name: History of LAT in TEE Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0; indicates that the patient had TEE in the past where LAT was present
Variable: TEE\_historyof\_LAT\_date Display name: Date of TEE where LAT was diagnosed in the past Type: Clinical Compulsory: No Categories and Units details: If above is true, provide date of previous TEE
Variable: TEE\_SEC Display name: transesophageal echocardiography spontaneous echo contrast Type: TEE Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: TEE\_DSEC Display name: transesophageal echocardiography dense spontaneous echo contrast Type: TEE Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: TEE\_LAAV Display name: transesophageal echocardiography left atrial appendage flow velocity Type: TEE Compulsory: Yes Categories and Units details: value in cm/s
Variable: TEE\_LAT Display name: Presence of left atrial appendage thrombus Type: TEE Compulsory: Yes
Categories and Units details:
Variable: CT\_date Display name: Date of computed tomography Type: Other modalities Compulsory: No Categories and Units details: If CT was performed, date of scan
Variable: CT\_DICOM\_available Display name: Availability of CT DICOM data Type: Other modalities Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: CT\_CAC\_score Display name: Coronary Artery Calcium Score Type: Other modalities Compulsory: No Categories and Units details: If CAC scan was performed, CAC score in Agatston Units
Variable: CT\_LA\_Volume Display name: LA Volume in CT Type: Other modalities Compulsory: No Categories and Units details: ml; only if LA volume was assessed in CT
Variable: ECG\_date Display name: Date of ECG Type: Other modalities Compulsory: No
Categories and Units details:
Variable: ECG\_dicom\_available Display name: Availability of ECG DICOM data Type: Other modalities Compulsory: No
Categories and Units details:
Variable: CMR\_date Display name: Date of Cardiac Magnetic Resonance Type: Other modalities Compulsory: No
Categories and Units details:
Variable: CMR\_dicom\_available Display name: Availability of CMR DICOM data Type: Other modalities Compulsory: No
Categories and Units details:
Variable: ablation\_type Display name: Type of catheter ablation Type: Ablation Compulsory: No Categories and Units details: Cryobaloon ablation = 1, Pulsed field ablation = 2, RF ablation = 3, Other = 4
Variable: first\_ablation Display name: First ablation or re-do Type: Ablation Compulsory: No Categories and Units details: Yes = 1, No = 0 (0 indicates re-do)
Variable: electroanatomical\_mapping Display name: Type of catheter ablation Type: Ablation Compulsory: No Categories and Units details: Yes = 1, No = 0; indicates if the procedure was electroanatomical map was created
Variable: LVZ Display name: Presence of low-voltage zones (LVZ) Type: Ablation Compulsory: No Categories and Units details: Yes = 1, No = 0; LVZ should be measured in sinus rhythm excluding pulmonary veins, preferably with multipolar catheter. Threshold: \<0.5mV on sinus rhythm, \<0.3mV on AF
Variable: LVZ\_locations Display name: Locations of LVZ Type: Ablation Compulsory: No Categories and Units details: Multiple choice: anterior wall, posterior wall, superior wall (Huo T., Gaspar M., Pohl et al. Europace 20 (2018) 956-962)
Variable: ablation targets Display name: Regions of ablation energy Type: Ablation Compulsory: No Categories and Units details: Multiple choice: PVI, anterior wall, posterior wall, superior wall
Variable: fluoro\_time Display name: Time duration of fluoroscopy Type: Ablation Compulsory: No Categories and Units details: Minutes
Variable: DLP Display name: Dose length product Type: Ablation Compulsory: No Categories and Units details: mGy\*cm
Variable: dwell\_time Display name: Time in the left atrium (dwell time) Type: Ablation Compulsory: No Categories and Units details: Minutes; Defined as time since the catheters entered left atrium
Variable: complications Display name: Complications during ablation Type: Ablation Compulsory: No Categories and Units details: if any, indicate what kind
Atrial fibrillation (AF) is the most common cardiac arrythmia, that affects 37% Europeans over 55 years old, representing a major burden for the society and health systems. One of the most devastating consequences of AF is ischemic stroke, often caused by embolization of cerebral arteries with a left atrial appendage thrombus (LAT), which can form in left atrial appendage in the presence of AF. As it has little contractility on its own, emptying and filling of left atrial appendage relies on the function of the left ventricle and the left atrium.
AF as well as atrial flutter promote the formation of LAT and are therefore associated with an increased risk of thromboembolic events. The mechanism of stroke is complex, but embolization with LAT accounts for the majority of events and it can be triggered by sinus rhythm restoration through procedures commonly performed in patients with AF - cardioversion or catheter ablation. Therefore, cardioversion and catheter ablation in the presence of LAT are contraindicated.
Transoesophageal echocardiography (TEE) is considered the modality of choice to detect LAT with high sensitivity and specificity and is currently recommended before cardioversion or catheter ablation as an alternative to a 3-week course of oral anticoagulation. Current guidelines, however, leave room for an individual decision to either perform or not perform TEE before catheter ablation or cardioversion in a chronically anticoagulated patient but suggest no tools to assess the risk of LAT. To address this unmet clinical need, we have previously shown that by combining clinical data and measurements from transthoracic echocardiography in a machine-learning model it is possible to predict the risk of LAT formation. Importantly, our results indicated, that TTE-derived measurements played the greatest role in predicting LAT.
Despite significant advancements in interventional technologies, the selection of appropriate therapeutic methods and perioperative procedures remains a significant challenge. Patients eligible for interventional procedures related to AF often undergo numerous diagnostic tests, including computed tomography of the heart, transoesophageal and transthoracic echocardiography, electrocardiography (EKG), and electroanatomic mapping during the ablation procedure. Non-invasive multimodal imaging plays central role in the peri-ablation period, informing important therapeutic decisions and facilitating the procedure. The essence of this project is the prospective collection of high-quality imaging data from these multiple modalities and clinical data, which will allow for a better understanding of the relationships between anatomy, hemodynamic function, and clinical observation in patients with AF in the future. Ultimately the data might serve for the development of tools which could efficiently predict the risk of LAT by means of less invasive and cheaper approaches than the ones which are currently used. The resulting multimodal database will also form a foundation for future studies targeted at informing therapeutic decisions in patients undergoing catheter ablation of AF.
2. Study Objectives
2.1. Main objective: To create a multimodal, multicentre registry of clinical and imaging data to develop predictive models based on state-of the art artificial intelligence to support the diagnostic and therapeutic process for patients undergoing AF catheter ablation and cardioversion.
2.2. Specific objectives:
2.2.1. Specific Aim 1 Creation of artificial intelligence-based models to predict the risk of formation of left atrial appendage thrombus and estimate the left atrial appendage emptying velocity obtained from transoesophageal echocardiography based on the analysis of transthoracic echocardiographic images and clinical data.
2.2.2. Specific Aim 2 Assessment of inter-reader and intra-reader agreement in the clinical interpretation of left atrial appendage images and left atrial appendage thrombus diagnosis in transoesophageal echocardiography.
2.2.3. Specific Aim 3 Development of models that fuse information from multiple modalities (for instance from transthoracic echocardiography and cardiac CT) to provide better prognosis and guide therapeutic decisions in patients with atrial fibrillation.
2.2.4. Specific Aim 4 Comparison of the effectiveness of different methods of imaging the left atrium in predicting thromboembolic events.
2.2.5. Specific Aim 5 Creation of a high-quality multicentre imaging database for additional future auxillary nalyses and studies.
3. Study Methodology
To maximize the amount of collected data the study allows both retrospective and prospective data collection. The scope of collected data is the same in retrospective and prospective collection with certain data types being optional and subject to availability.
3.1. Inclusion criteria
Patients with:
* history of atrial fibrillation,
* who are undergoing medically justified transoesophageal echocardiography to assess the presence of left atrial appendage thrombus before catheter ablation of atrial fibrillation (including patients who had transoesophageal echocardiography during the ablation procedure). OR
* who undergo catheter ablation without prior transoesophageal echocardiography (if the center also collects additional imaging data listed in point 2.5 below) 3.2. Exclusion criteria
* Age \< 18 years old.
3.3 3.3. Types of collected data
Data type: Clinical data Compulsory or optional: Includes compulsory and optional fields Format: Tabular, collected using a dedicated eCRF Additional remarks: The detailed list of fields with possible values is shown in Appendix 1
Data type: TTE Compulsory or optional: Compulsory Format: DICOM Additional remarks: Recorded before TEE preferably on the same day. In case of retrospective data TTE and TEE acquired within 72h
Data type: TEE Compulsory or optional: Compulsory if the patient had TEE Format: DICOM
Additional remarks:
Data type: Cardiac CT Compulsory or optional: Optional Format: DICOM Additional remarks: Contrast enhanced cardiac CT before ablation procedure. Can be a study performed for EP planning or for CAD diagnostics. Any study performed before the ablation regardless of timing can be used
Data type: Non-contrast Cardiac CT Compulsory or optional: Optional Format: DICOM Additional remarks: Non-contrast chest CT. Preferred is ECG-gated calcium scoring CT reconstructed with thin slices (preferably 0.5mm).
Data type: Cardiac Magnetic Resonance (CMR) Compulsory or optional: Optional Format: DICOM
Additional remarks:
Data type: Digitalised Electrocardiogram Compulsory or optional: Optional Format: DICOM (or pdf) Additional remarks: Performed on the day of the catheter ablation or cardioversion or day before.
Data type: Electroanatomical map Compulsory or optional: Optional Format: Proprietary Additional remarks: Not to be transferred but only stored locally in the participating center for possible ancillary studies
Data type: Follow-up for MACE Compulsory or optional: Optional Format: Event date Additional remarks: Depending on the local regulations and possibility, the follow-up data for all-cause mortality, stroke, myocardial infarction, onset or worsening of heart failure will be obtained based on ICD-9 and ICD 10 codes from the national health insurance databases. Alternatively, data can be obtained by telephone interview
Data type: Follow-up for AF Compulsory or optional: Optional Format: Event date Additional remarks: Depending on the local availability of follow-up data for AF recurrence
3.4. Guidelines for data acquisition
3.4.1. Guidelines for Acquisition of Transthoracic and Transesophageal Echocardiography
* For prospective collection the TEE and TEE should be performed ideally in the same day, TTE directly before TEE. For the retrospective cohort TTE can be acquired up to 3 days before TEE, as long as there were no important changes in patients' condition during this period (i.e. clinical worsening, change of rhythm, heart rate etc).
* ECG electrodes should be connected for both TTE and TEE (not compulsory for retrospective data)
* The acquisition length should be set to 5 seconds (set the start acquisition at the moment when acquire button is pressed to minimise unwanted movement). For retrospective data shorter clips are acceptable.
3.4.1.1. Acquisition of TTE \[filenames are given in brackets\]:
1. Four-chamber apical projection \[4ch.dcm\]
2. Two-chamber apical projection \[2ch.dcm\]
3. Three-chamber apical projection \[3ch.dcm\]
4. Four-chamber apical projection - optimized for LA \[4chLA.dcm\]
5. Two-chamber apical projection - optimized for LA \[2chLA.dcm\]
6. 3D full volume (preferably acquired from 4 or more heart cycles) \[3d\_tte.dcm\] The projections must encompass the entire heart, including the atria. Measurements to be performed at site (if impossible, some of these measurements can also be performed by the coordinating site).
<!-- -->
1. Cardiac chamber dimensions (PLAX) \[plax.dcm\]
2. Velocities E, A, med. E\', lat. E\' (still images) \[mitral\_flow.dcm, medial\_tdi.dcm, lateral\_tdi.dcm\]
3. Tricupid regurgitation spectral image (still images) \[tr.dcm\]
3.4.1.2. Acquisition of TEE:
1. Projection on LAA (Left Atrial Appendage): 0, 45, 90, 135 degrees, and other projections that are necessary to correctly image the entire LAA according to the investigator/ echocardiographer \[laa\_0.dcm, laa\_45.dcm, laa\_135.dcm etc.\]
2. 3D acquisition of the volume that contains LAA (multi-beat-optimized) \[3d\_LAA.dcm\]
3. Measurement of maximum emptying velocity of LAA 1cm from the LAA ostium - at least three measurements in two different scanning angles, averaged.
4. Acquisition of spectral Doppler image of LAA emptying (three images from two or more scanning angles) (still images) \[laav\_60.dcm, laav135.dcm, laav\_45.dcm\]
3.4.1.3. Other modalities: There are no specific acquisition requirements for cardiac CT, CMR or ECG - these studies should be performed according to local standard protocols.
Appendix 1 - Dictionary of tabular data
Variable: CaseID Display name: Case ID Type: ID Compulsory: Yes Categories and Units details: Consecutive IDs unique for each entry
Variable: PatientID Display name: Patient ID Type: ID Compulsory: Yes Categories and Units details: Consecutive ID for patients; if the patient is entered to the registry more than once, he/she should have the same PatientID
Variable: procedure\_type Display name: Type of planned intervention Type: Clinical Compulsory: Yes Categories and Units details: ablation = 1, cardioversion = 2, NA = 3, laa\_closure = 4, valvular disease = 5, infective endocarditis = 6
Variable: AF Display name: Atrial fibrillation Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: AFL Display name: Atrial flutter Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: arrythmia\_duration Display name: Paroxysmal, persistent, or long-standing Type: Clinical Compulsory: Yes Categories and Units details: persistent = 1, paroxysmal = 2, long-standing persistent = 3, NA = 4
Variable: Persistent\_arrythmia\_time Display name: Time since the onset of persistent arrythmia Type: Clinical Compulsory: Yes Categories and Units details: Time in months or days. Enter 0 for paroxysmal arrythmia
Variable: Persistent\_arrythmia\_time\_unit Display name: Months or days Type: Clinical Compulsory: Yes Categories and Units details: Months = 0, Days = 1
Variable: Disease\_duration Display name: Duration of AF Disease Type: Clinical Compulsory: Yes Categories and Units details: Time (approximate) since the first diagnosis of atrial fibrillation
Variable: Disease\_duration\_unit Display name: Months or Years Type: Clinical Compulsory: Yes Categories and Units details: Months = 0, Years = 1
Variable: EHRA Display name: EHRA scale Type: Clinical Compulsory: Yes Categories and Units details: I = 1, IIa = 2, IIb = 3, III = 4, IV = 5, NA = 6
Variable: Age Display name: Age Type: Clinical Compulsory: Yes Categories and Units details: Age in years
Variable: Sex Display name: Sex Type: Clinical Compulsory: Yes Categories and Units details: Male = 1, Female = 2
Variable: Height Display name: Height Type: Clinical Compulsory: Yes Categories and Units details: Height in cm
Variable: Weight Display name: Weight Type: Clinical Compulsory: Yes Categories and Units details: Weight in kg
Variable: HF\_status Display name: Heart failure Type: Clinical Compulsory: Yes Categories and Units details: HFmrEF= 1, HFpEF = 2, HFrEF = 3, No HF = 4
Variable: NYHA Display name: NYHA scale Type: Clinical Compulsory: Yes Categories and Units details: I = 0, II = 1, III = 2, IV = 3, No HF = 4
Variable: MS Display name: Mitral stenosis Type: Clinical Compulsory: Yes Categories and Units details: mild = 1, moderate = 2, severe = 3, no MS = 4
Variable: MR Display name: Mitral regurgitation Type: Clinical Compulsory: Yes Categories and Units details: mild = 1, moderate = 2, severe = 3, no MR = 4
Variable: AS Display name: Aortic stenosis Type: Clinical Compulsory: Yes Categories and Units details: mild = 1, moderate = 2, severe = 3, no AS = 4
Variable: AR Display name: Aortic regurgitation Type: Clinical Compulsory: Yes Categories and Units details: mild = 1, moderate = 2, severe = 3, no AR = 4
Variable: mitral\_valve\_replacement Display name: Mitral valve replacement Type: Clinical Compulsory: Yes Categories and Units details: biological = 1, mechanical = 2, No MVR = 3
Variable: aortic\_valve\_replacement Display name: Aortic valve replacement Type: Clinical Compulsory: Yes Categories and Units details: biological = 1, mechanical = 2, No AVR = 3
Variable: Implanatable\_device Display name: Presence of implantable electronic device Type: Clinical Compulsory: Yes Categories and Units details: None = 0, pacemaker = 1, ICD = 2, CRT-D = 3, CRT-P = 4, Implantable Recorder = 5, S-ICD = 6, Leadless pacemaker = 7
Variable: stroke\_type Display name: History of stroke Type: Clinical Compulsory: Yes Categories and Units details: haemorrhagic stroke = 1, ischaemic stroke = 2, both = 3, no history of stroke = 4
Variable: peripheral\_embolus Display name: History of peripheral embolism Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: revasc Display name: Prior revascularisation Type: Clinical Compulsory: Yes Categories and Units details: CABG = 1, No history of revasc = 2, PCI = 3, PCI+CABG = 4
Variable: cad Display name: Coronary Artery Disease Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: vascular\_disease Display name: Vascular disease Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: past\_bleeding Display name: History of bleeding Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: CKD Display name: Chronic kidney disease Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: HT Display name: Hypertension Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: DM Display name: Diabetes Mellitus Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: liver\_disease Display name: Liver disease Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: labile\_INR Display name: Labile INR Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: alcohol Display name: Alcohol abuse Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: smoking Display name: Smoking Type: Clinical Compulsory: Yes Categories and Units details: currently = 1, in the past = 2, non-smoker = 3
Variable: malignant\_tumor Display name: Malignant tumor or cancer Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0, Malignant tumor or cancer or hematologic malignant disease
Variable: COPD Display name: Chronic obstructive pulmonary disease Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: asthma Display name: Asthma Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: hyperthyroidism Display name: Hyperthyroidism Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: hypothyroidism Display name: Hypothyroidism Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: LA\_dimension Display name: Left atrial AP dimension Type: TTE Compulsory: Yes Categories and Units details: Value in mm
Variable: LVDd Display name: Left ventricular internal diameter end diastole Type: TTE Compulsory: Yes Categories and Units details: Value in mm
Variable: RVDd Display name: Right ventricular internal diameter end diastole Type: TTE Compulsory: Yes Categories and Units details: Value in mm
Variable: EF\_TTE Display name: Left Ventricular Ejection Fraction Type: TTE Compulsory: Yes Categories and Units details: Value in %
Variable: LA\_area\_4ch Display name: Left atrial area in four-chamber view Type: TTE Compulsory: Yes Categories and Units details: Value in cm2
Variable: LA\_length\_4ch Display name: Left atrial length in four-chamber view Type: TTE Compulsory: No Categories and Units details: Value in cm
Variable: LA\_area\_2ch Display name: Left atrial area in two-chamber view Type: TTE Compulsory: No Categories and Units details: Value in cm2
Variable: LA\_length\_2ch Display name: Left atrial length in two-chamber view Type: TTE Compulsory: No Categories and Units details: Value in cm
Variable: LA\_volume\_sp Display name: Left atrial single-plane volume Type: TTE Compulsory: No Categories and Units details: Value in cm3
Variable: LA\_volume Display name: Left atrial biplane volume Type: TTE Compulsory: No Categories and Units details: Value in cm3
Variable: LAVI Display name: Left atrial volume index Type: TTE Compulsory: No Categories and Units details: Value in cm3/m2
Variable: E Display name: Peak E-wave velocity Type: TTE Compulsory: Yes Categories and Units details: Value in cm/s
Variable: A Display name: Peak A-wave velocity Type: TTE Compulsory: Yes Categories and Units details: Value in cm/s
Variable: Med\_Eprim Display name: Med E\' - Early diastolic medial mitral annulus velocity Type: TTE Compulsory: Yes Categories and Units details: Value in cm/s
Variable: Lat\_Eprim Display name: Lat E\' - Early diastolic lateral mitral annulus velocity Type: TTE Compulsory: Yes Categories and Units details: Value in cm/s
Variable: RA area Display name: Right atrial area Type: TTE Compulsory: No Categories and Units details: Value in cm2
Variable: Act Display name: Pulmonary acceleration time Type: TTE Compulsory: Yes Categories and Units details: Value in ms
Variable: lab\_date Display name: Lab Test Date Type: Lab Tests Compulsory: No Categories and Units details: If blood sample was drawn during hospitalization and lab test results are entered, please provide the date of lab tests
Variable: BNP Display name: NT-proBNP Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: Fib Display name: Fibrynogen Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: CRP Display name: C-reactive Protein Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: APTT Display name: Activated partial Thromboplastin Time Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: INR Display name: International Normalized Ratio Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: Hb Display name: Hemoglobin Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: RDW Display name: Red Cell Distribution Width Type: Lab Tests Compulsory: No
Categories and Units details:
Variable: Crea Display name: Creatinine Type: Lab Tests Compulsory: No Categories and Units details: mg/dl
Variable: months\_anticoagulation Display name: Months since initiation of anticoagulation Type: Medication Compulsory: Yes Categories and Units details: Time in months; if more than one year, enter 12
Variable: days\_anticoagulation Display name: Days since initiation of anticoagulation Type: Medication Compulsory: Yes Categories and Units details: (if \<1 month, otherwise leave blank)
Variable: anticoagulant Display name: Type of anticoagulant medication Type: Medication Compulsory: Yes Categories and Units details: apixaban\_2x5 = 1, rivaroxaban\_20 = 2, dabigatran\_2x150 = 3, acenocumarol = 4, warfarin = 5, apixaban\_2x2.5 = 6, rivaroxaban\_15 = 7, dabigatran\_2x110 = 8, LVH = 9, HNF = 10, no anticoagulation = 11
Variable: days\_dabigatran\_temp\_use Display name: Temporary use of dabigatran (days) Type: Medication Compulsory: Yes Categories and Units details: Explanation: This is perhaps site-specific. In our center, we change medication to dabigatran in the periprocedural period because of access to praxbind.
Variable: ASA Display name: intake of acetylsalicylic acid Type: Medication Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: clopidogrel Display name: intake of clopidogrel Type: Medication Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: tikagrelor Display name: intake of tikagrelor Type: Medication Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: prasugrel Display name: intake of prasugrel Type: Medication Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: base\_rythm Display name: Rhythm at the time of study Type: Clinical Compulsory: Yes Categories and Units details: SR = 1, AF = 1, Afl = 2
Variable: TEE\_in\_cath\_lab Display name: TEE performed in cath lab Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0; indicates if TEE was performed during the ablation procedure
Variable: TEE\_historyof\_LAT Display name: History of LAT in TEE Type: Clinical Compulsory: Yes Categories and Units details: Yes = 1, No = 0; indicates that the patient had TEE in the past where LAT was present
Variable: TEE\_historyof\_LAT\_date Display name: Date of TEE where LAT was diagnosed in the past Type: Clinical Compulsory: No Categories and Units details: If above is true, provide date of previous TEE
Variable: TEE\_SEC Display name: transesophageal echocardiography spontaneous echo contrast Type: TEE Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: TEE\_DSEC Display name: transesophageal echocardiography dense spontaneous echo contrast Type: TEE Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: TEE\_LAAV Display name: transesophageal echocardiography left atrial appendage flow velocity Type: TEE Compulsory: Yes Categories and Units details: value in cm/s
Variable: TEE\_LAT Display name: Presence of left atrial appendage thrombus Type: TEE Compulsory: Yes
Categories and Units details:
Variable: CT\_date Display name: Date of computed tomography Type: Other modalities Compulsory: No Categories and Units details: If CT was performed, date of scan
Variable: CT\_DICOM\_available Display name: Availability of CT DICOM data Type: Other modalities Compulsory: Yes Categories and Units details: Yes = 1, No = 0
Variable: CT\_CAC\_score Display name: Coronary Artery Calcium Score Type: Other modalities Compulsory: No Categories and Units details: If CAC scan was performed, CAC score in Agatston Units
Variable: CT\_LA\_Volume Display name: LA Volume in CT Type: Other modalities Compulsory: No Categories and Units details: ml; only if LA volume was assessed in CT
Variable: ECG\_date Display name: Date of ECG Type: Other modalities Compulsory: No
Categories and Units details:
Variable: ECG\_dicom\_available Display name: Availability of ECG DICOM data Type: Other modalities Compulsory: No
Categories and Units details:
Variable: CMR\_date Display name: Date of Cardiac Magnetic Resonance Type: Other modalities Compulsory: No
Categories and Units details:
Variable: CMR\_dicom\_available Display name: Availability of CMR DICOM data Type: Other modalities Compulsory: No
Categories and Units details:
Variable: ablation\_type Display name: Type of catheter ablation Type: Ablation Compulsory: No Categories and Units details: Cryobaloon ablation = 1, Pulsed field ablation = 2, RF ablation = 3, Other = 4
Variable: first\_ablation Display name: First ablation or re-do Type: Ablation Compulsory: No Categories and Units details: Yes = 1, No = 0 (0 indicates re-do)
Variable: electroanatomical\_mapping Display name: Type of catheter ablation Type: Ablation Compulsory: No Categories and Units details: Yes = 1, No = 0; indicates if the procedure was electroanatomical map was created
Variable: LVZ Display name: Presence of low-voltage zones (LVZ) Type: Ablation Compulsory: No Categories and Units details: Yes = 1, No = 0; LVZ should be measured in sinus rhythm excluding pulmonary veins, preferably with multipolar catheter. Threshold: \<0.5mV on sinus rhythm, \<0.3mV on AF
Variable: LVZ\_locations Display name: Locations of LVZ Type: Ablation Compulsory: No Categories and Units details: Multiple choice: anterior wall, posterior wall, superior wall (Huo T., Gaspar M., Pohl et al. Europace 20 (2018) 956-962)
Variable: ablation targets Display name: Regions of ablation energy Type: Ablation Compulsory: No Categories and Units details: Multiple choice: PVI, anterior wall, posterior wall, superior wall
Variable: fluoro\_time Display name: Time duration of fluoroscopy Type: Ablation Compulsory: No Categories and Units details: Minutes
Variable: DLP Display name: Dose length product Type: Ablation Compulsory: No Categories and Units details: mGy\*cm
Variable: dwell\_time Display name: Time in the left atrium (dwell time) Type: Ablation Compulsory: No Categories and Units details: Minutes; Defined as time since the catheters entered left atrium
Variable: complications Display name: Complications during ablation Type: Ablation Compulsory: No Categories and Units details: if any, indicate what kind
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Atrial Fibrillation and Flutter
Heart Failure
Artificial Intelligence (AI)
Echocardiography
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AF or AFl patients
Patients with AF or AFl in whom TEE will be performed (to assess their eligibility for cardioversion or ablation), hospitalized in a participating center during study period.
Transoesophageal echocardiography
Intervention Type
DIAGNOSTIC_TEST
Imaging data obtained with transoesophageals echocardiography will be retained as well as data from transthoracic echocardiography and from other imaging modalities, if available
Catheter ablation
Intervention Type
PROCEDURE
Cathether ablation of atrial fibrillation substrate using one of available methods.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transoesophageal echocardiography
Imaging data obtained with transoesophageals echocardiography will be retained as well as data from transthoracic echocardiography and from other imaging modalities, if available
Intervention Type
DIAGNOSTIC_TEST
Catheter ablation
Cathether ablation of atrial fibrillation substrate using one of available methods.
Intervention Type
PROCEDURE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
\- All patients with AF or AFl in whom TEE will be performed (to assess their eligibility for cardioversion or ablation), hospitalized in a participating center during study period (all consecutive patients).
Exclusion Criteria
Age\<18, lack of informed, written consent to the TEE
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Military Institute od Medicine National Research Institute
OTHER
Sponsor Role
collaborator
National Institute of Cardiology, Warsaw, Poland
OTHER
Sponsor Role
collaborator
Medical University of Silesia, Katowice, Poland
UNKNOWN
Sponsor Role
collaborator
St. Anne's University Hospital Brno, Czech Republic
OTHER
Sponsor Role
collaborator
John Paul II Hospital, Krakow
OTHER
Sponsor Role
collaborator
Nowa Sol Multidyscyplinary Hospital, Poland
UNKNOWN
Sponsor Role
collaborator
University in Zielona Góra
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Konrad Pieszko
MD, PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Konrad Pieszko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Zielona Gora
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Anne Hospital
Brno, , Czechia
Site Status
NOT_YET_RECRUITING
Nowa Sol Multidyscyplinary Hospital
Nowa Sól, Lubusz Voivodeship, Poland
Site Status
RECRUITING
Medical University of Silesia
Katowice, , Poland
Site Status
NOT_YET_RECRUITING
John Paul II Hospital
Krakow, , Poland
Site Status
RECRUITING
Military Institute of Medicine National Research Institute
Warsaw, , Poland
Site Status
RECRUITING
National Institute of Cardiology
Warsaw, , Poland
Site Status
NOT_YET_RECRUITING
Collegium Medicum, University of Zielona Góra
Zielona Góra, , Poland
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Czechia
Poland
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zdeněk STÁREK, MD, PhD
Role: primary
Katarzyna Mizia-Stec, MD, PhD, prof
Role: primary
Andrzej Gackowski, MD, PhD, prof
Role: primary
Beata Uzieblo-Zyczkowska, MD, PhD
Role: primary
Ewa Kowalik, MD, PhD, prof
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1/KARD/UZ/2023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Artificial Intelligence Models to Predict Clinically Relevant Cardiovascular Outcomes
NCT06847100
COMPLETED
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
NCT00652522
COMPLETED
NA
Ablation of Atrial Fibrillation in Heart Failure Patients
NCT03062241
UNKNOWN
NA
Examination of Fibrillation Atria Using Magnetic Resonance Imaging and Endocardial High-density Mapping
NCT05539313
UNKNOWN
Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers
NCT03401931
WITHDRAWN
Volumetric Quantification of Epicardial Fat Using Semiautomated High Resolution Atrial CT Segmentation in Patients With Atrial Fibrillation Receiving Catheter Ablation
NCT06559787
ACTIVE_NOT_RECRUITING
Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation
NCT06098664
UNKNOWN
Non-invasive Monitoring for Early Detection of Atrial Fibrillation
NCT03243474
COMPLETED
Left Atrial Thrombus on Transesophageal Echocardiography
NCT03591627
UNKNOWN
Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)
NCT06911099
RECRUITING
Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF
NCT00643188
COMPLETED
PHASE4
Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation
NCT06630936
RECRUITING
Intelligent Monitoring to Predict Atrial Fibrillation
NCT06600620
SUSPENDED
Noninvasive Mapping Before Surgical Ablation
NCT06803615
ACTIVE_NOT_RECRUITING
Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation
NCT06083012
ACTIVE_NOT_RECRUITING
Endocardial Mapping with the CoreMap EP Mapping System
NCT06529978
RECRUITING
NA
FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation
NCT06260670
COMPLETED
NA
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
NCT06557616
RECRUITING
Atrial Fibrillation in Active Cancer Patients
NCT04696081
RECRUITING
Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation
NCT03812601
COMPLETED
Atrial Fibrillation Registry 2017
NCT05023590
UNKNOWN
NA
Follow-up of Kryptogenic Stroke Patients With Implantable vs. Non-invasive Devices to Detect Atrial Fibrillation.
NCT02641678
COMPLETED
Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older
NCT04375241
COMPLETED
Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation
NCT02726698
COMPLETED
Non-invasive Substrate Evaluation in Atrial Fibrillation
NCT04496336
COMPLETED