Wireless sensor could help doctors Fine-Tune heart failure treatment in real time
NCT ID NCT06241430
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
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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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
RECRUITINGNew York, New York, 10032, United States
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Other studies related to the condition(s) this trial covers.
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- Nerve-stimulating implant tested for easing heart failure symptoms