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 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
NCT ID:
NCT01528150
Eligibility Criteria:
Inclusion Criteria:
* Approved Class I or Class II indication per: European Society of Cardiology (ESC) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker, OR American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker
* Require a new Accent MRI™ pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
* Is ≥ 18 years of age.
* Able to provide written informed consent prior to any investigational related procedure.
* 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 implanted medical device (e.g., Implantable Cardioverter Defibrillator (ICD), neurostimulator, 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, plug or adaptor.
* Have a prosthetic tricuspid heart valve.
* Are currently participating in another investigational device or drug investigation.
* Are allergic to Dexamethasone sodium phosphate (DSP).
* Are pregnant or planning to become pregnant during the duration of the study.
* Have a life expectancy of less than 12 months from Screening due to any life-threatening condition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01528150
Study Brief:
Protocol Section:
NCT01528150