NL-OMON30087Not yet recruitingNot Applicable
Algorithm verification STudy with an External Reveal (Investigationel Xt) - ASTERIX
Vitatron0 sites230 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 230
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •- 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
Investigators
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