TRAjectories and CLinical ExpeRiences of ICD Therapy Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT05116176
Status
Enrolling By Invitation

Conditions

  • Implantable Defibrillator User

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Dec 15, 2021
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
500 participants (estimated)

Primary Outcome Measure

Clinical Trajectories after ICD implantation [ Time Frame: Patients will be followed quarterly for 18 months or to death. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-

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Beth Israel Deaconess Medical Center· Boston, MA

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