Atrial arrhythmias heart rhythm disturbances
Conditions
Interventions
None listed
Sponsors
Vitatron
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Patient is willing to wear two external recording devices for a 48 hour period; •Patient is willing to give his/her informed consent; •Patient fulfills at least one of the following: - Patient has atrial fibrillation or flutter with an indication for pharmacological cardioversion; - Patient has atrial fibrillation or flutter with an indication for electrical cardioversion; - Patient is scheduled for cardiac valve surgery or has undergone cardiac valve surgery maximally 2 days previously; - Ambulatory patient who will undergo pulmonary vein ablation or atrial flutter ablation; - Ambulatory patient who has undergone pulmonary vein ablation or atrial flutter ablation at least two months previously, with currently suspected recurrence of atrial fibrillation or flutter; - Ambulatory patient with suspected paroxysmal atrial fibrillation or other atrial tachyarrhythmia.
Exclusion criteria
Exclusion criteria: • Patient has an implanted pacemaker or ICD • Patient has an allergy against adhesive ECG electrodes • The study will interfere with a therapeutic or diagnostic procedure which is planned or expected within the 48 hour study period • Patient is a minor, legally incompetent, or does not meet other local requirements for participation in a clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the performance of the detection algorithms for detecting episodes of atrial tachyarrhythmia (including atrial fibrillation, atrial flutter, and atrial tachycardia) with a duration of at least 2 minutes, compared to the detection possible using a 48 hour Holter recording. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare AF burden determined using the S-Spare compared to the 48 Hour Holter To compare the detection performance of the algorithms for all atrial tachyarrhythmia episodes To compare the detection performance of the algorithms for episodes of atrial fibrillation To compare detection performance of the algorithms for episodes of other atrial tachyarrhythmia To investigate Sensitivity, Specificity, and PPV of the algorithm under the studied conditions on a per patient basis To investigate Sensitivity, Specificity, and PPV of the algorithm under the studied conditions over all episodes of all patients To investigate the variance of R-wave sensing intra- and inter-individually | — |
Countries
Netherlands
Outcome results
None listed