Atrial fibrillation Atrial cardiomyopathy
Conditions
Interventions
Group 1: Performance of a 12-lead-resting ECG (at study inclusion and at follow-up after 12 and 24 months) with standard electrode position (SEP) and a calculated optimized electrode position (OEP), t
Sponsors
Universitätsklinikum Freiburg, Klinik für Kardiologie und Angiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: First cohort (First PVI with EAM): 1. Male and female patients aged =18 years and 3 points, without current indication for OAC and without known atrial fibrillation, atrial flutter or atrial tachycardia Both cohorts: 1. Written informed consent for study participation prior to enrollment 2. Ability to understand the nature of the trial and the trial related procedures and to comply with them
Exclusion criteria
Exclusion criteria: 1. Prior cardiac surgery or left atrial catheter ablation 2. Short life expectancy due to comorbid conditions 3. Heart failure, NYHA 4 4. Severe valvular heart disease (mitral or aortic valvulopathy >Grade 2/3) 5. Other major disabling disease 6. Acute inflammatory or infectious disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First cohort: Accuracy of atrial cardiomyopathy (AtCM) diagnosis and AtCM staging (as defined by EAM) by amplified p-wave analysis (APWA) using OEP versus SEP Second cohort: Identification of the optimal APWA threshold for major adverse cerebral and cardiovascular events (MACCE) prediction by APWA using OEP versus SEP. MACCE events comprise new onset AF/atrial flutter, clinical signs of heart failure, stroke/systemic embolism, myocardial infarction, hospitalization for cardiac causes and cardiovascular death. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Prediction of arrhythmia recurrence after PVI during 24 months follow-up by APWA using OEP versus SEP - Correlation between APWA using OEP versus SEP and arrhythmia burden - Correlation between APWA using OEP versus SEP and left atrial mechanical function (e.g. left atrial strain, left atrial emptying fraction) assessed by TTE - Correlation between APWA using OEP versus SEP and CHA2DS2-VA(S)c-score - Correlation between APWA using OEP versus SEP andpresence/duration of atrial high rate episodes/rhythm events in patients with a cardiac implantable electronic device (CIED) - Accuracy of AtCM diagnosis and AtCM staging (defined by EAM) by APWA versus established ECG-markers (standard P-waveduration, P-terminal force in V1, P-terminal duration in V1, Pterminal amplitude in V1) - Identification of the minimum number of ECG leads required to diagnose and quantify AtCM - Identification of biomarkers that are associated with AtCM or MACCE | — |
Countries
Germany
Contacts
Public ContactMartin Eichenlaub
Universitätsklinikum Freiburg, Klinik für Kardiologie und Angiologie
Outcome results
None listed