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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT02318550
Eligibility Criteria:
1. Patient has a non-MRI conditional permanently implanted pacemaker or ICD implanted after 2001
2. Patient has a strong clinical indication for MRI where MRI is the diagnostic modality of choice for specific disease state without acceptable alternative imaging technologies as determined by the ordering physician and a radiologist
3. Patient is at least 18 years of age
4. Patient is willing and able to sign study informed consent and HIPAA authorization
Exclusion Criteria:
1. Non-device related contraindication for MRI (such as implanted metallic objects, claustrophobia, morbid obesity)
2. Presence of capped/abandoned/epicardial leads or subcutaneous coil
3. Pregnancy
4. Device generator at elective replacement interval
5. Abdominal device implant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02318550
Study Brief:
Protocol Section:
NCT02318550