The objective of the study is to investigate the performance of the arrhythmia detection algorithms that will be built into the Reveal XT® insertable loop recorder. The Reveal XT® detection algorithms are designed to detect atrial tachyarrhythmias,…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
This study is conducted in order to validate newly developed algorithms to
permanently detect and monitor AF. It is believed that information about the
frequency and amount of AF in an individual patient may augment the treatment
for a patient suffering from paroxysmal AF. Useful AF related diagnostic
parameters to optimize patient treatment are e.g. AF burden, number of
episodes, duration of AF episodes, etc. Unfortunately these parameters are
difficult to assess without continuous monitoring, as even in symptomatic
patients with AF, the majority of AF-episodes go unnoticed by the patient [1,
2, 3]. This gives rise to the current situation where symptoms and patient
history are of limited value for the diagnosis and follow-up of AF.
Study objective
The objective of the study is to investigate the performance of the arrhythmia
detection algorithms that will be built into the Reveal XT® insertable loop
recorder. The Reveal XT® detection algorithms are designed to detect atrial
tachyarrhythmias, as well as ventricular tachyarrhythmias and bradycardia. In
this study the specific performance of the detection algorithms for detecting
episodes of atrial fibrillation and atrial tachycardia (including atrial
flutter) with a duration of at least 2 minutes will be investigated by means of
an external device.
Study design
The ASTERIX Study is a pre-market, non-randomized, open-label, multi-center
explorative study.
Study burden and risks
This study is considered to entail minimal risk. The potential risks to a
subject are expected to be the same as those encountered during standard ECG
testing or Holter recording.
P.O. Box 5227
6802 EE
Nederland
P.O. Box 5227
6802 EE
Nederland
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12605.094.06 |