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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT02041702
Eligibility Criteria:
Inclusion Criteria
* Have an approved indication per American College of Cardiology(ACC)/ American Heart Association(AHA)/ Heart Rhythm Society(HRS)/ European Society of Cardiology(ESC) guidelines for implantation of a pacemaker
* Will receive a new dual chamber pacemaker and leads
* Be willing to undergo an elective MRI scan without complete sedation, that is ,under consciousness during MRI scan
* Be able to provide informed consent for study participation
* Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
* Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)
* Age≥18 years
* Subjects must be able to undergo pectoral implantation
Exclusion Criteria
* Having an existing pacemaker or Implantable Cardioverter Defibrillator (ICD) .A new pacemaker and lead is required for enrollment
* Permanent Atrial Fibrillation/Flutter
* Are medically indicated for an MRI scan at the time of enrollment
* Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc
* Have a non-MRI compatible device or material implanted
* Have a lead extender or adaptor
* Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore
* Are currently participating in a clinical investigation that includes an active treatment arm
* 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 due to any condition
* Subjects with exclusion criteria required by local law (e.g. age)
* Are unable to comply with the follow up schedule
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02041702
Study Brief:
Protocol Section:
NCT02041702