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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT01258218
Eligibility Criteria:
Inclusion Criteria:
* Approved Class I or Class II indication per ESC guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker.
* Receiving a new Accent MRITM pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
* Ability to provide informed consent for study participation.
* Is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion Criteria:
* Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment).
* Have an existing active/inactive implanted medical device (e. g., Neurostimulator, infusion pump, etc.).
* Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
* Have a lead extender or adaptor.
* Have a mechanical, prosthetic or bioprosthetic tricuspid heart valve.
* Have an abdominal diameter (approximately \> 60cm) which results in contact with the magnet façade.
* Are currently participating in a study that includes an active treatment arm.
* Are pregnant or planning to become pregnant during the duration of the study.
* Have a life expectancy of less than 6 months due to any condition.
* Are less than 18 years of age.
* Are unable to comply with the follow up schedule.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01258218
Study Brief:
Protocol Section:
NCT01258218