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Implantable Defibrillator User

TRAjectories and CLinical ExpeRiences of ICD Therapy Study

Sponsored by Beth Israel Deaconess Medical Center

About this trial

Last updated 2 years ago

Study ID

2021P000054

Status

Enrolling by invitation

Type

Observational

Placebo

No

Accepting

18-75 Years
65+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 months ago

What is this trial about?

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).

What are the Participation Requirements?

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.

Locations

Location

Status