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Heart failure patients get a High-Tech watchdog: implanted sensor aims to cut hospital visits

NCT ID NCT06783335

Disease control Sponsor: Endotronix, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will compare two groups of people with chronic heart failure: those who receive the Cordella PA Sensor System (an implanted device that monitors pressure in the lung artery) and those who get standard medication alone. Researchers will track about 2,150 participants for two years to see if the device reduces deaths and hospitalizations related to heart failure. The goal is to see if real-time pressure monitoring helps doctors adjust treatment earlier.

What this could mean

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

Active substance
Cordella PA Sensor System (implantable device that monitors pressure in the pulmonary artery)
What this could lead to
If successful, this could show that the Cordella device helps people with chronic heart failure live longer and avoid hospital stays.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by differences between groups. The device requires a procedure to implant, which carries risks like infection or bleeding.

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 2,150 people

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

Started

Feb 2025

Expected to finish

Dec 2030

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

Patients with NYHA III chronic HF

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 for Cordella PA Sensor System Cohort: * Received Cordella PA Sensor System implant between 10/1/2024-12/31/2029 * Documented chronic heart failure with NYHA Class III symptoms * On guideline-directed medical therapy based on ejection fraction status: * For reduced EF (≤40%): At least one fill of ACE/ARB/ARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic * For preserved EF (\>40%): At least one fill of a loop diuretic * Has continuous health insurance enrollment for 12 months prior to implant Inclusion Criteria for Standard of Care Control Cohort: * Two or more encounters with diagnosis codes for chronic systolic and/or diastolic heart failure * Documented ejection fraction reading within 6 months (+ or -) of second heart failure encounter * On guideline-directed medical therapy based on ejection fraction status: * For reduced EF (≤40%): At least one fill of ACE/ARB/ARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic * For preserved EF (\>40%): At least one fill of a loop diuretic * Has continuous health insurance enrollment for 12 months prior to study entry Exclusion Criteria: * No implanted pulmonary artery sensor or monitoring at any time (Standard of Care Control Cohort only) * Record of temporary mechanical circulatory support during baseline period * Diagnosis of cardiogenic shock during baseline period * Receiving palliative care/hospice during baseline period * Record of end-stage renal disease during baseline period * Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder congestive heart failure heart disorder heart failure moderate heart failure

As listed by the trial registrant

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

Heart failure 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

    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

  • Endotronix

    RECRUITING

    Naperville, Illinois, 60563, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.