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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT01999751
Eligibility Criteria:
Inclusion Criteria:
1. Permanent Pacemaker or ICD implanted for at least 6 weeks
2. Referred for medically-required MRI scan
3. Age greater than or equal to 18 years
Exclusion Criteria:
1. ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm, GDT Prizm-2 and MDT GEM-I series
2. Epicardial lead or subcutaneous array
3. Device has reached elective replacement indicator (ERI) or end of life (EOL)
4. Other usual contraindications to MRI scanning
5. Known or suspected lead fracture or abandoned lead
6. Pacemaker dependent patients with an ICD that cannot be programmed to asynchronous pacing (DOO/VOO)
7. Clinical factors that are deemed by the PI or Sub-I to increase the participant's risk above an acceptable clinical threshold
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01999751
Study Brief:
Protocol Section:
NCT01999751