TRAjectories and CLinical ExpeRiences of ICD Therapy Study

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Nov 1, 2021

Keywords

ClinConnect Summary

Study Objectives and Design

The specific aims, applicable methods, and main hypotheses of the TRACER-ICD study are as follows:

Aim 1: To characterize the clinical course of patients aged \>65 after ICD implantation by establishing a multicenter prospective cohort (N=500). Baseline (verbal and in-person) and quarterly (phone, electronic health records \[EHR\], remote monitoring) data collected up to 18 months or death will include: a. geriatric assessments (e.g. frailty, cognition,1 functional status; b. comorbidities; c. quality of life and symptom burden; d. health services use; e. SDM h...

Gender

ALL

Eligibility criteria

• Patients scheduled for ICD implantation will be identified at participating sites by site staff. Eligibility criteria will include the following, all of which must be met by all participants for participation:
• • 1. Patient receiving new primary prevention ICD (single, dual chamber, or subcutaneous system)
• • 2. Age \>65 years
• • 3. English-speaking (assessment instruments are only available/validated in English)
• • 4. Sufficient cognitive ability to provide consent (i.e. answer simple questions on study participation, purpose and procedures)
• Candidates meeting the following exclusion criteria at baseline will be excluded from study participation:
• • 1. Receipt of cardiac resynchronization therapy device
• • 2. Participation in another investigational drug or intervention trial expected to influence any of the outcomes of interest in this study
• • 3. Current drug or alcohol use or dependence that, in the opinion of the Site Principle Investigator, would interfere with adherence to study requirements.