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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT02506569
Eligibility Criteria:
Inclusion Criteria:
* Implanted with Implantable Cardioverter Defibrillator (ICD) system according to Clinical Investigational Plan (CIP)
* ICD system was implanted in the pectoral region
* Implantation at least 5 weeks prior to enrollment date
* Patient body height ≥ 140 cm
* Age ≥ 18 years
* Right Ventricular pacing threshold (at 0.4 ms) measurable and ≤ 2.0 V
* Written informed consent
* Able and willing to complete MRI testing
* Able and willing to complete all testing required by the clinical protocol
* Available for all follow-up visits at the investigational site
Exclusion Criteria:
* Standard contraindication for MRI scans
* Patient shows signs of a twiddler's syndrome, i.e. fiddles with implant
* Explantation, exchange or reposition of ICD or lead within 5 weeks prior to enrollment date
* Charging status of the battery is Elective Replacement Indicator (ERI) or End of Service (EOS)
* MRI scan within 5 weeks prior to enrollment date
* R-wave sensing amplitude \< 6.5 millivolt
* Lead impedance less than 200 or greater than 1500 Ohm
* Life expectancy of less than six months
* Cardiac surgery in the next six months
* Pregnant or breastfeeding
* Participation in another interventional clinical investigation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02506569
Study Brief:
Protocol Section:
NCT02506569