Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:10 AM
Ignite Modification Date:
2025-12-25 @ 5:10 AM
NCT ID:
NCT03850327
Eligibility Criteria:
Inclusion Criteria:
* Patient is at high risk of developing a clinically important cardiac arrhythmia; or Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
* Patient is able to understand the nature of study and has provided written informed consent.
* Patient is willing and able to perform all follow up visits at the study site.
* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Exclusion Criteria:
* Patients implanted with ICD or pacemaker.
* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.
* Patient is participating in another interventional clinical investigation
* Patient´s life-expectancy is less than 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03850327
Study Brief:
Protocol Section:
NCT03850327