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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT02636712
Eligibility Criteria:
Inclusion Criteria:
* Subject must have the ImageReady System as their initial (de novo) pacing system implant
* Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines5
* Subject is able and willing to undergo an MR scan
* Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study at the intervals defined by this protocol
* Subject is age 18 or above
Exclusion Criteria:
* Subject has or has had any pacing or ICD system implants
* Subject has any implants or devices that are not suitable for MR scan
* Subject is enrolled in any other concurrent study that might interfere with this study
* Subject has documented life expectancy of less than 12 months
* Women of childbearing potential who are or might be pregnant at the time of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02636712
Study Brief:
Protocol Section:
NCT02636712