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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT03828357
Eligibility Criteria:
Inclusion Criteria:
To participate in this clinical study, the subject must meet all of the following inclusion criteria:
* Have an approved indication for implantation of a ICD
* Be a Chinese national
* Will be implanted with one of the following device/lead combinations evaluated in this study:
* Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle (RV)
* Group 2: Fortify Assura single-chamber ICD, with an Optisure lead
* Group 3: Ellipse DR dual-chamber ICD with a Durata lead in the RV and a Tendril STS lead in the right atrium (RA)
* Group 4: Fortify Assura ICD and an Optisure lead in the RV and an Isoflex lead in the RA
* Be willing to undergo an elective MRI scan without sedation ≥ 45 days after implant NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
* Be able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
* Be willing and able to comply with the prescribed follow-up tests and procedures
* Are not contraindicated for an MRI scan (per the MRI Screening Form)
* Subjects who are at least 18 years of age (or older, required by local law)
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:
* Have a competitor's MRI compatible endocardial lead implanted or capped
* Have another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
* Have other non-MRI compatible device or material implanted. The following examples may be included as long as labelling of these devices allow MRI scans conducted per this protocol:
* MRI compatible knee replacements, hip replacements, stents, etc.
* MRI compatible mechanical, prosthetic, and bio prosthetic heart valves
* Non-removable dental implants
* Have a lead extender, adaptor, or capped/abandoned lead
* Enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this study as determined by Abbott.
* Pregnant or planning to become pregnant during the duration of the subject's participation in the study
* Have a life expectancy of less than 12 months due to any condition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03828357
Study Brief:
Protocol Section:
NCT03828357