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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT01460992
Eligibility Criteria:
Inclusion Criteria:
* Pacemaker system consisting solely of the EVIA/ENTOVIS pacemaker and Safio S pacemaker leads
* The pacemaker system has to be implanted, repositioned or exchanged at least 5 weeks prior to enrollment
* Age more than 18 years
* Understand the nature of the procedure
* Able and willing to complete MRI testing
* Able and willing to activate and use the Cardio Messenger
* Give written informed consent
* Able to complete all testing required by the clinical protocol
* Ability to measure atrial and/or ventricular pacing threshold(s)\* (at 0.4 ms)
* All pacing thresholds do not exceed 2.0V @0.4ms.
* Available for follow-up visit at the investigational site
* Patient body height greater or equal to 140 cm
* Pectoral implantation
* The ascertained lead impedance is between 200 and 1500 Ohms.
Exclusion Criteria:
* No EVIA/ENTOVIS /Safio S pacemaker system implanted
* Pacing threshold(s) (at 0.4 ms) and sensing amplitudes are not measurable
* Meet one or more of the contraindications
* Being pregnant
* Have a life expectancy of less than three months
* Cardiac surgery already scheduled in the next three months
* Enrolled in another cardiac clinical investigation
* Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, other active medical devices, non-MRI compatible devices (e.g. mechanical tricuspid valve)
* Have other metallic artifacts/components in body that may interact with MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01460992
Study Brief:
Protocol Section:
NCT01460992