AnaLysIs of Both Sex and Device Specific FactoRs on Outcomes in PAtients with Non-Ischemic Cardiomyopathy - Bio Libra

    Not Recruiting
Updated on 6 December 2021
ejection fraction
sudden cardiac death


Secondary Objectives
  • All-cause mortality, VT or VF alone, risk of cardiac death, and sudden cardiac death for the total cohort, as well as by sex and by the implanted device type.
  • Compare the predicted incidence of sudden death using the Seattle Proportional Risk score to the observed incidence in this patient population.
Tertiary Objectives
  • Evaluation of baseline cardiovascular and diabetes medication use and dosage in subjects implanted with either an ICD or CRT-D and stratified by sex.
  • Assessment of left ventricular reverse remodeling at 12 months for subjects implanted with CRT-D using echocardiography, as characterized by the improvement of left ventricular ejection fraction (LVEF) and the improvement of left ventricular end-systolic volume (LVESV).
  • Analysis of the rate of inappropriate ICD therapy (ATP or shock for rhythms adjudicated as non-VT/VF).
  • Analysis of rate of VT or VF treated with shock only by sex and by device type.
  • Evaluation of the observed major complication rates by sex and by device type.


There is no direct benefit to the patient for participating in this research study. The results of this research study may benefit other patients, however, these benefits cannot be guaranteed. In particular, this study aims to enroll at least 40% women. If the patient is a woman who joins this study, their participation can help contribute to the improved understanding of ICD/CRT-D benefits for women with non-ischemic cardiomyopathy, which may help future generations of women.

Condition Cardiomyopathy
Clinical Study IdentifierTX220310
Last Modified on6 December 2021

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