Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardio… (NCT03884608) | Clinical Trial Compass
CompletedNot Applicable
Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
United States1,000 participantsStarted 2019-05-09
Plain-language summary
The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
✓. Patient has non-ischemic etiology of cardiomyopathy
✓. Patient is successfully implanted with a de novo BIOTRONIK ICD or CRT-D device and commercially available leads no more than 30 days prior to consent or is scheduled for de novo implantation of a BIOTRONIK ICD or CRT-D device no more than 30 days post consent
✓. Patient is able to understand the nature of the study and provide informed consent
✓. Patient is available for standard of care follow-up visits to occur at least yearly at the study site for to the expected 3 years of follow-up
✓. Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessenger
✓. Patient age is greater than or equal to 18 years