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Wireless sensor could help doctors Fine-Tune heart failure treatment in real time

NCT ID NCT06241430

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests whether a small wireless sensor placed in the pulmonary artery can help doctors better manage medications for people with heart failure and a leaky mitral valve. The sensor constantly measures pressure inside the heart, giving doctors real-time data to adjust treatments. Participants already scheduled for a non-surgical valve repair will also receive the sensor. The goal is to see if this leads to better symptom control and quality of life over 12 months.

What this could mean

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

Active substance
CardioMEMS wireless pulmonary artery pressure sensor
What this could lead to
If successful, this approach could help doctors fine-tune heart failure medications in real time, potentially reducing hospitalizations and improving quality of life.
What could go wrong
This is a small, early-stage study (60 people) focused on feasibility and outcomes like symptom scores, not survival. The sensor requires a procedure and may not benefit everyone.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Started

Dec 2024

Expected to finish

Jun 2030

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.

Ages

18 to 90 years

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: * Significant (moderate-severe \[3+\] or severe \[4+\] secondary MR) * Left ventricular dysfunction (ejection fraction \>20% and \<50%) * New York Heart Association (NYHA) class II-IVa symptoms * Sign informed consent to participate in the study Exclusion Criteria: * Left ventricular (LV) end-systolic dimension 70 mm * PA systolic pressure 70 mmHg (fixed) * Mitral valve (MV) orifice area \<4.0 cm2 * Commissural MR jet or leaflet anatomy not suitable for mTEER * Likely to undergo heart transplantation or LV assist device implantation in the next 12 months * Recurrent (i.e., \>1) pulmonary embolism or deep vein thrombosis * Complex congenital heart disease * Mechanical right heart valve (tricuspid or pulmonic) * Cardiac resynchronization therapy implanted within 3 months of enrollment * Hypersensitivity to aspirin and/or clopidogrel * History of medication non-adherence

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

    RECRUITING

    New York, New York, 10032, United States

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