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Vest that shocks heart back to life under scrutiny

NCT ID NCT05135403

Disease control Sponsor: Kestra Medical Technologies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study follows over 5,000 people who are prescribed a wearable defibrillator vest to prevent sudden cardiac arrest. Researchers will analyze data from the device to see how often it successfully corrects dangerous heart rhythms and how often it delivers unnecessary shocks. The goal is to confirm the vest works well in everyday life.

What this could mean

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

Active substance
Wearable cardioverter defibrillator (WCD)
What this could lead to
If successful, this study could confirm that the wearable defibrillator reliably treats dangerous heart rhythms, helping prevent sudden cardiac arrest in at-risk patients.
What could go wrong
This is an observational registry study, not a controlled trial, so results may be influenced by real-world variability. The device may still deliver inappropriate shocks or fail to convert some arrhythmias.

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 5,179 people

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

Started

Nov 2021

Expected to finish

Oct 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The ASSURE Wearable Cardioverter Defibrillator (WCD) system is indicated for adult patients who are at risk or at perceived risk of sudden cardiac arrest (SCA) and are not immediate candidates for, or refuse, an implantable defibrillator.

Ages

18 years and older

Sex

Anyone

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.

Inclusion Criteria: * Adult patient prescribed the ASSURE wearable cardioverter defibrillator * Provided written informed consent to participate in the ASSURE Patient Registry Exclusion Criteria: * Patients who do not meet the Inclusion criteria

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Conditions

The condition(s) this trial relates to.

Death, Sudden, Cardiac sudden cardiac arrest

As listed by the trial registrant

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

Sudden cardiac arrest

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98033, United States

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