Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit. |
Atrial cardiomyopathy (ACMP)-associated complications |
through study completion, a median of 2.5 years |
|
Secondary |
ACMP progression or regression |
As measured by LAVI (left atrial volume index) increase or decrease |
through study completion, a median of 2.5 years |
|
Secondary |
Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT) |
Hospitalisations/urgent visits for AF, AFL or AT |
through study completion, a median of 2.5 years |
|
Secondary |
Hospitalisations/urgent visits for heart failure (HF) |
Hospitalisations/urgent visits for heart failure |
through study completion, a median of 2.5 years |
|
Secondary |
Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA)) |
Hospitalisations/urgent visits for ischemic stroke (including TIA) |
through study completion, a median of 2.5 years |
|
Secondary |
Cardiovascular death |
Cardiovascular death |
through study completion, a median of 2.5 years |
|
Secondary |
All-cause mortality |
All-cause mortality |
through study completion, a median of 2.5 years |
|
Secondary |
Repeated hospitalisations/urgent visits for ACMP associated outcomes |
(AF/AFL/AT recurrence, HF, ischemic stroke admissions) |
through study completion, a median of 2.5 years |
|
Secondary |
AF symptoms |
Measured by European Heart Rhythm Association (EHRA)-score |
through study completion, a median of 2.5 years |
|
Secondary |
Symptoms and improve quality of life (QoL) |
Measured by AFEQT questionnaire |
through study completion, a median of 2.5 years |
|
Secondary |
Symptoms and improve quality of life (QoL) |
Measured by EuroQol-5D-5L questionnaire. (higher score indicating a better QoL) |
through study completion, a median of 2.5 years |
|
Secondary |
Healthcare costs |
Healthcare costs |
through study completion, a median of 2.5 years |
|
Secondary |
Transthoracic echo measures |
This is a exploratory outcome and will be defined during the trial by input of the other workpackages of the EmbRACE consortium (i.e. strain measures, LAVI etc) |
through study completion, a median of 2.5 years |
|
Secondary |
Extended ECG measures |
This is a exploratory outcome and will be defined during the trial by input of the other workpackages of the EmbRACE consortium (i.e. p wave duration voltage or surface etc) |
through study completion, a median of 2.5 years |
|
Secondary |
Biomarkers |
Exploratory outcome |
through study completion, a median of 2.5 years |
|
Secondary |
Electrophysiological mapping (subset, e.g. low voltage areas) |
This is a exploratory outcome and will be defined during the trial by input of the other workpackages of the EmbRACE consortium (i.e. low voltage areas, potential fragmentation etc) |
through study completion, a median of 2.5 years |
|
Secondary |
CT (subset, epicardial fat distribution) |
This is a exploratory outcome and will be defined during the trial by input of the other workpackages of the EmbRACE consortium (i.e. epicardial fat distribution) |
through study completion, a median of 2.5 years |
|
Secondary |
MRI (subset, fibrosis and fatty infiltration)* |
This is a exploratory outcome and will be defined during the trial by input of the other workpackages of the EmbRACE consortium (i.e. fibrosis and fatty infiltration) |
through study completion, a median of 2.5 years |
|