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ENROLLING BY INVITATION
NCT05116176

TRAjectories and CLinical ExpeRiences of ICD Therapy Study

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2021-12-15

Completion Date

2026-03

Last Updated

2025-07-16

Healthy Volunteers

No

Interventions

DEVICE

Implantable cardioverter-defibrillators

500 patients age \>65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs).

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States