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:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT03803969
Eligibility Criteria:
Inclusion Criteria:
Eligible patients will meet all the following:
1. Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
2. Subject must provide written informed consent prior to any clinical investigation related procedure.
3. Have an approved indication for continuous arrhythmia monitoring with an Insertable Cardiac Monitor.
4. Should be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
5. Female subjects of child-bearing potential should have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
1. Subject has previously received an Insertable Cardiac Monitor.
2. Subject is currently enrolled or intend to participate in another clinical investigation, which could confound the results of this trial during this clinical study as determined by the sponsor.
3. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
4. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03803969
Study Brief:
Protocol Section:
NCT03803969