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New study follows 500 seniors with heart devices to improve care decisions

NCT ID NCT05116176

Knowledge-focused Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will follow 500 patients over age 65 who are receiving a new implantable cardioverter-defibrillator (ICD) for the first time to prevent sudden cardiac arrest. Researchers will track their health, quality of life, and experiences for 18 months, with optional follow-up up to 10 years. The goal is to better understand how patients fare after getting an ICD and to improve tools that help doctors and patients make informed decisions together.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
implantable cardioverter-defibrillator (ICD)
What this could lead to
If successful, this study could help doctors better predict which older patients will benefit most from an ICD and improve shared decision-making.
What could go wrong
This is an observational study, not a treatment trial. It will not test a new therapy, and results may not apply to all patients or change current practice directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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)

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Implantable defibrillator user

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

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