Implantable Defibrillator UserTRACER-ICDNCT05116176
TRAjectories and CLinical ExpeRiences of ICD Therapy Study
An observational study of Implantable Defibrillator User, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Implantable Defibrillator User
- What is being tested?
- Implantable cardioverter-defibrillators
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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)
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:
- Patient receiving new primary prevention ICD (single, dual chamber, or subcutaneous system)
- Age >65 years
- English-speaking (assessment instruments are only available/validated in English)
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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).
Read the 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
- Being tested
- Implantable cardioverter-defibrillators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable cardioverter-defibrillatorsDevice
500 patients age >65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients will be followed quarterly for 18 months or to death.
Outcomes after ICD Implantation
Death/Poor Quality of Life (combined endpoint)
Measured: Up to 18 months
Semi-competing risks model of deaths and/or ICD shocks
Personalized outcome profiles for death +/- ICD shocks
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start15 Dec 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantable Defibrillator UserStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Hebrew SeniorLife, University of Colorado, Denver, Emory University, Mayo Clinic, Saint Luke's Health System
- Responsible party
- Principal investigator, Daniel B. Kramer, Beth Israel Deaconess Medical Center
- Investigators
- Daniel B Kramer, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116176
- Sponsor's protocol ID
- 2021P000054
- Acronym
- TRACER-ICD
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2021
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAjectories and CLinical ExpeRiences of ICD Therapy Study
- ClinicalTrials.gov ID
- NCT05116176
- Acronym / sponsor ID
- TRACER-ICD / 2021P000054
- Conditions
- Implantable Defibrillator User
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Hebrew SeniorLife, University of Colorado, Denver, Emory University, Mayo Clinic, Saint Luke's Health System
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable cardioverter-defibrillators500 patients age >65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs). | Device | – |
Primary outcome
Clinical Trajectories after ICD implantation
Time frame: Patients will be followed quarterly for 18 months or to death.
Group-based trajectory modeling will identify patient clusters with distinct trajectories of functional status and quality of life following ICD implantation.
Outcomes after ICD Implantation
Time frame: Up to 18 months
Death/Poor Quality of Life (combined endpoint)
Semi-competing risks model of deaths and/or ICD shocks
Time frame: Up to 18 months
Personalized outcome profiles for death +/- ICD shocks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Kramer, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implantable Defibrillator User, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Trajectories after ICD implantation (time frame: Patients will be followed quarterly for 18 months or to death.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.