Algorithm verification STudy with an External Reveal (Investigationel Xt)

Conditions: Atrial arrhythmias
heart rhythm disturbances
10007521

Registration Number: NL-OMON30087

Lead Sponsor: Vitatron

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 230

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

• 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the performance of the detection algorithms for detecting episodes<br /><br>of atrial tachyarrhythmia (including atrial fibrillation, atrial flutter, and<br /><br>atrial tachycardia) with a duration of at least 2 minutes, compared to the<br /><br>detection possible using a 48 hour Holter recording.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To compare AF burden determined using the S-Spare compared to the 48 Hour<br /><br>Holter<br /><br>To compare the detection performance of the algorithms for all atrial<br /><br>tachyarrhythmia episodes<br /><br>To compare the detection performance of the algorithms for episodes of atrial<br /><br>fibrillation<br /><br>To compare detection performance of the algorithms for episodes of other atrial<br /><br>tachyarrhythmia<br /><br>To investigate Sensitivity, Specificity, and PPV of the algorithm under the<br /><br>studied conditions on a per patient basis<br /><br>To investigate Sensitivity, Specificity, and PPV of the algorithm under the<br /><br>studied conditions over all episodes of all patients<br /><br>To investigate the variance of R-wave sensing intra- and inter-individually </p><br>