TRAjectories and CLinical ExpeRiences of ICD Therapy Study

NCT ID: NCT05116176

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2026-03-31

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).

Detailed Description

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 history; and f. ICD-recorded physical activity (minutes/day).

Factors associated with death and poor quality of life will be identified. Group-based trajectory modeling will identify patient clusters with distinct trajectories of functional status and quality of life following ICD implantation.

H1: A model integrating frailty and clinical factors will predict (a) death, (b) poor quality of life, and (c) unfavorable functional trajectories after ICD implantation.

Aim 2: To validate a personalized prediction model of treatment outcomes of ICDs. We will apply our established semi-competing risks approach5 to the prospective cohort, enriched by the baseline geriatric assessments, to predict individual patients' probabilities of the following outcome profiles at 6, 12, and 18 months post-implant: a. death without prior shock, b. death with prior shock, c. survival without prior shock, and d. survival with prior shock. The independent contribution of frailty, cognitive dysfunction, baseline quality of life, and functional status (e.g. total deficits in ADL and IADL) to model performance will be evaluated.

H2: Addition of frailty, cognitive dysfunction, quality of life, and functional status to a model with cardiovascular variables will significantly improve model performance as assessed by area under the curve (AUC).

Aim 3: To identify optimal strategies for incorporating personalized outcome profiles into SDM. The main cohort's baseline interview and EHR review will provide quantitative data on past SDM tools used by physicians. We will develop a prototype individualized version of the Colorado SDM tool that incorporates 18-month outcome profiles using our semi-competing risk model. We will perform semi-structured interviews of cardiologists (N=20) as well as patients (N=20) recruited from the main cohort regarding process mapping of SDM from clinic to implant procedure, including timing, content, format preferences, and impressions of the prototype individualized tool.

Conditions

Implantable Defibrillator User

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Implantable cardioverter-defibrillators

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

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Hebrew SeniorLife

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Saint Luke's Health System

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Daniel B. Kramer

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel B Kramer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P000054

Identifier Type: -

Identifier Source: org_study_id