TRAjectories and CLinical ExpeRiences of ICD Therapy Study

NCT05116176 | Enrolling By Invitation

• 1 other identifier: 2021P000054
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Implantable Defibrillator User

Outcome Measures

Primary Outcomes (3)

• Clinical Trajectories after ICD implantation

  Group-based trajectory modeling will identify patient clusters with distinct trajectories of functional status and quality of life following ICD implantation.

  Patients will be followed quarterly for 18 months or to death.

• Outcomes after ICD Implantation

  Death/Poor Quality of Life (combined endpoint)

  Up to 18 months

• Semi-competing risks model of deaths and/or ICD shocks

  Personalized outcome profiles for death +/- ICD shocks

  Up to 18 months

Interventions

Implantable cardioverter-defibrillators DEVICE

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 (N.B.: 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)

You may not qualify if:

• Receipt of cardiac resynchronization therapy device
• Participation in another investigational drug or intervention trial expected to influence any of the outcomes of interest in this study
• Current drug or alcohol use or dependence that, in the opinion of the Site Principle Investigator, would interfere with adherence to study requirements.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• University of Pennsylvania: collaborator
• Hebrew SeniorLife: collaborator
• University of Colorado, Denver: collaborator
• Emory University: collaborator
• Mayo Clinic: collaborator
• Saint Luke's Health System: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Defibrillators, Implantable

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Daniel B Kramer, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: November 10, 2021
• Study Start: December 15, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)