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Heart implants may soon track your breathing

NCT ID NCT06089694

Knowledge-focused Sponsor: Medtronic Cardiac Rhythm and Heart Failure 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study checks whether implanted heart devices (ICDs and CRT-Ds) can measure breathing rates as accurately as a standard capnography machine. Researchers will compare readings from the device's special Holter mode with those from capnography in people with heart failure. If the device-derived rates are consistently within a few breaths per minute of the true rate, it could lead to simpler monitoring.

What this could mean

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

Active substance
Enabling Sensor Research Holter Mode feature within Crome and Cobalt ICD and CRT-D devices
What this could lead to
If successful, this could allow heart devices to monitor breathing without extra equipment, potentially helping manage heart failure.
What could go wrong
This is a small, early-stage study focused on accuracy, not treatment. The feature may not work well in all patients or situations.

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

61 people

The number who actually took part.

Started

Nov 2023

Finished

Jun 2024

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 target population for this study will include adult subjects who are ≥18 years of age, who have an active, implanted Crome or Cobalt ICD or CRT-D system that's been implanted for at least 30 days and which has not yet reached the Recommended Replacement Time (RRT), and who do not have any contraindications that would impact their ability to complete the required breathing and exercise activities, which aligns with the key eligibility criteria for the study. A minimum of 30% of all enrolled subjects will have a documented history of heart failure and a minimum of 20% of all enrolled subjects will be female (as identified at birth).

Ages

18 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.

Inclusion Criteria: 1. Subject has an active CromeTM or CobaltTM ICD or CRT-D MRI SureScanTM system which has been implanted for at least 30 days and which has not yet reached the Recommended Replacement Time (RRT) 2. Subject is implanted with one of the following models of a true bipolar right ventricular lead manufactured by Medtronic: * Model 6946M * Model 6947 * Model 6947M * Model 6935 * Model 6935M 3. Subject is ≥ 18 years of age 4. Subject (or subject's legally authorized representative) is willing and able to provide written informed consent 5. Subject is willing and able to comply with study procedures Exclusion Criteria: 1. Subject has existing condition that necessitates the use of supplemental oxygen 2. Subject has active acute respiratory infection or respiratory disorder that may affect ability to perform breathing or exercise activities, as assessed by the investigator 3. Any concomitant condition that might endanger the subject through participation in the study or interfere with study procedures, as assessed by the investigator 4. Subject has an active or suspected lead integrity issue, in the opinion of the investigator 5. Subject is enrolled in another study that could confound the results of this study 6. Subject has NYHA Class IV heart failure

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Heart failure

Contacts and locations

Locations

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota, 56303-1900, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma, 73135, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705-1852, United States

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