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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT02493205
Eligibility Criteria:
Inclusion Criteria:
1. Patient is indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor
2. Patient is willing to undergo implant in holding area setting with only local anesthetic and/or oral anti-anxiety medications for sedation (2 mg of Valium or Ativan) at patient request.
3. Patient is 18 years of age or older.
4. Patient is willing to provide informed consent and authorize disclosure of personal health information in accordance with state and national regulations.
Exclusion Criteria:
1. Patient has reduced immune function or is otherwise at high risk for infection
2. Patient has had a recent (within 30 days) or otherwise unresolved infection.
3. Patient is implanted or indicated for implant with a pacemaker, Implantable Cardiac Device (ICD), Cardiac Resyncronization Therapy (CRT) or hemodynamic monitoring system.
4. Patient is participating in another clinical trial that may have an impact on the trial endpoints.
5. Patient has a super-therapeutic INR \> 3.0.
6. Patient considered by Principal Investigator and/or sub-investigator to be inappropriate for the trial for any reason.
7. Patient's life expectancy is less than 1 year.
8. Patient is pregnant.
9. Patient has an unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure.
10. Inability to comply with planned trial procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02493205
Study Brief:
Protocol Section:
NCT02493205