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Tiny Lung-Artery sensor could help heart failure patients live longer

NCT ID NCT06306573

Disease control Sponsor: Abbott Medical Devices 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study follows 2,500 people with moderate heart failure (NYHA Class II or III) who already have a CardioMEMS sensor implanted in their lung artery. The sensor wirelessly sends pressure readings to doctors, who use the data to adjust medications. Researchers will track survival over two years to see if using this real-time information helps patients live longer compared to a historical benchmark. The goal is to confirm the device's long-term safety and real-world effectiveness.

What this could mean

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

Active substance
CardioMEMS HF System (implantable wireless pressure sensor)
What this could lead to
If successful, this study could confirm that using real-time pressure data from inside the lung artery helps people with heart failure live longer and avoid hospital stays.
What could go wrong
This is an observational follow-up study, not a controlled trial, so it cannot prove cause and effect. The device itself carries risks like infection or sensor failure, and results may not apply to all heart failure patients.

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 2,500 people

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

Started

Dec 2022

Expected to finish

Dec 2029

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 intended population for this RWE PAS includes Medicare FFS beneficiaries with symptomatic NYHA Class II and III heart failure implanted with a CardioMEMS PA Sensor in the commercial setting.

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: * Subject implanted with a CardioMEMS PA Sensor and enrolled in Merlin.net * Subject resides in the United States as documented in Merlin.net * NYHA Class II or Class III as documented in Merlin.net at the time of CardioMEMS implant (only NYHA Class II subjects contribute to the Primary Cohort) * Subject identified in Merlin.net data can be linked to Medicare FFS claims * Subject is enrolled in Medicare Part A and B, and not enrolled in Medicare Part C, at implant and for 12 months prior to implant, to establish qualification for CardioMEMS * Subject ≥18 years of age at time of CardioMEMS implant Exclusion Criteria: * Subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to CardioMEMS implant

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Conditions

The condition(s) this trial relates to.

heart failure mild heart failure moderate heart failure

As listed by the trial registrant

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

Heart failure nyha class II Heart failure nyha class III

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

  • Abbott Medical

    Atlanta, Georgia, 30313, United States

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