Implantable cardioverter-defibrillators: 500 patients age \>65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs).
Study summary
This is a prospective cohort study of older patients receiving implantable cardioverter-defibrillators. The purpose of the TRACER-ICD study is to conduct a prospective cohort investigation with the goal of 500 patients age \>65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs). Patients will be followed quarterly for 18 months with interviews, electronic record review, and remote monitoring to characterize clinical and functional trajectories following device implantation, with permission for extended electronic follow-up for up to 10 years (Aim 1). This cohort will support validation and refinement of an established model for predicting personalized outcome profiles for ICD therapies and death (Aim 2). Lastly, we will combine electronic record review with semi-structured interviews with patients and physicians to evaluate physician and patient experiences with a prototype individualized shared decision-making (SDM) tool (Aim 3).
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Clinical Trajectories after ICD implantation — Patients will be followed quarterly for 18 months or to death. Group-based trajectory modeling will identify patient clusters with distinct trajectories of functional status and quality of life following ICD implantation.
Outcomes after ICD Implantation — Up to 18 months Death/Poor Quality of Life (combined endpoint)
Semi-competing risks model of deaths and/or ICD shocks — Up to 18 months Personalized outcome profiles for death +/- ICD shocks
Trial sites (1)
Facility
City
Region
Status
Beth Israel Deaconess Medical Center
Boston
Massachusetts
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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