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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT00907361
Eligibility Criteria:
Inclusion Criteria:
* Male or female 18 years or older
* Able to provide informed consent
* Permanent implanted pacemaker or ICD
* Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology as determined by the ordering physician.
* Patient is scheduled for non-thoracic MRI (joint, extremity, brain, pelvis, cervical, and lumbar or sacral spine)
Exclusion Criteria:
* Metallic objects that represent a contraindication to MR imaging, including: intra-orbital or intra-ocular retained metal fragments, and intracranial vascular clips and coils
* Claustrophobia unresponsive to pre-procedure sedatives
* Morbid obesity (abdominal diameter \>60 cm)
* ICD or pacemaker generator placement prior to 2002
* ICD and pacing dependent
* Pregnancy
* Device generator battery voltage at elective replacement index (ERI)
* Presence of active implantable medical device (other than pacemaker or ICD)
* Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
* Presence of implanted cardiac device in the abdominal position
* Pacemaker or ICD that is labeled as MRI-Conditional (approved by the FDA for exposure to MRI).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00907361
Study Brief:
Protocol Section:
NCT00907361