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Tiny implanted sensor could give early warning for lung artery disease

NCT ID NCT04078243

Knowledge-focused Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are studying whether an implanted wireless monitor that measures pressure in the lung arteries, combined with wearable activity trackers, is safe and practical for people with pulmonary hypertension. The study enrolls 120 adults with different groups of the disease. Participants receive the pressure monitor and wear activity trackers while researchers collect data to see how pressure changes relate to daily activity and health outcomes.

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, an implanted wireless monitor that measures pressure in the lung arteries, plus wearable activity trackers
What this could lead to
If the approach works, doctors could one day track lung artery pressure and daily activity remotely, which may help them adjust treatment sooner for people with pulmonary hypertension.
What could go wrong
This is an early observational study with 120 participants, so it cannot prove that monitoring improves outcomes. Implanting a pressure sensor carries small risks of bleeding, infection, or device problems, and the data may not apply to all 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 120 people

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

Started

Jan 2020

Expected to finish

Sep 2028

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 with a confirmed diagnosis of PH at right heart catheterisation (RHC) and New York Heart Association (NYHA) class III, prior admission for treatment of heart failure.

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: * Diagnosis of pulmonary hypertension (Group I,II,III and IV) * Age 18 years * Estimated glomerular filtration rate (eGFR) \> 25 * Body mass index (BMI) \< 35 (or equivalent) * Pulmonary artery (PA) branch 7mm * Negative pregnancy test (If female of childbearing age) * Written, informed consent completed * Willingness of the patient to comply Exclusion Criteria: * Group IV PH * Active infection * Pulmonary embolus (PE) or deep vein thrombosis (DVT) * Major cardiovascular event within past 2 months * Cardiac resynchronisation therapy (CRT) device within past 3 months * Mechanical right heart valve * Known coagulation disorder * Known hypersensitivity to aspirin or clopidogrel.

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Conditions

The condition(s) this trial relates to.

pulmonary hypertension

As listed by the trial registrant

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

Pulmonary hypertension

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

  • Sheffield Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Sheffield, South Yorkshire, S5 7AU, United Kingdom

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