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

  • STATUS
    Recruiting
Updated on 24 November 2020
ejection fraction
shock
sudden cardiac death

Summary

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.

 

Description

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.

Details
Condition Cardiomyopathy
Clinical Study IdentifierTX220310
Last Modified on24 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

All the following inclusion criteria have to be fulfilled at the time of patient consent for study participation
Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
Patient has non-ischemic etiology of cardiomyopathyii
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

Exclusion Criteria

To support the objectives of this investigation, the exclusion criteria at the time of patient consent include the following requirements
Patient meets secondary prevention ICD indication
Patient has ischemic etiology of cardiomyopathy
Patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes
Patient is expected to receive heart transplantation or ventricular assist device within 1 year
Patient life expectancy is less than 1 year
Patient reports pregnancy at the time of consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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