A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing … (NCT02787291) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study
United States227 participantsStarted 2016-05
Plain-language summary
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Are implanted with the Durata or Optisure lead for at least 60 days (can include patients with Durata or Optisure lead for \> 60 days OR patients with a new Ellipse VR ICD and/or Durata/Optisure lead implanted for at least 60 days
* Are implanted with an Ellipse VR ICD pectorally
* Be willing to undergo an elective MRI scan without sedation 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
* Capture threshold is stable \< 2.5V @ 0.5ms
* Ventricular sensing is measurable (patient has underlying rhythm \> 30bpm) and the sensing amplitude is \> 4mV
* 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)
Exclusion Criteria:
* 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 a lead revision of the Durata/Optisure lead occur \< 60 days of the baseline visit
* Have other non-MRI compatible device or material implanted NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as th…
What they're measuring
1
Number of Participants With MRI Scan Related Complications
Timeframe: MRI scan to 1 month post MRI scan
2
Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V
Timeframe: pre-MRI scan to 1 month post MRI scan
3
Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan