Can a tiny heart sensor make LVADs safer?

NCT ID NCT06682910

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 ยท Last updated Aug 21, 2026

Summary

This early trial is testing a small, implantable sensor that measures pressure inside the heart for people with heart failure who are getting a mechanical heart pump (LVAD). The goal is to see if the sensor can be safely and accurately placed and whether it can provide reliable pressure readings for up to six months. About 15 patients will take part, and the sensor will be placed in either the right or left upper chamber of the heart, depending on individual risk. The study focuses on safety and accuracy, not yet on whether it improves 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
A tiny implantable sensor that measures pressure inside the heart
What this could lead to
If it works, this sensor could give doctors a reliable way to monitor heart pressures in LVAD patients, potentially improving care and reducing complications.
What could go wrong
This is a very early, small study (15 people) focused on safety and accuracy. The sensor might not work as hoped, could move, or cause complications, and results 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.

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 15 people

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

Started

Dec 2024

Expected to finish

Dec 2027

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patient is scheduled to undergo an elective LVAD implantation via midline sternotomy based on routine practice at the participating center. * Patient is characterized as INTERMACS profile 2 or greater. * Patient is able and willing to provide written informed consent. * Patient is willing and able to comply with all required post-procedure follow-up visits. Exclusion Criteria: * Pre-operative coagulopathy or thrombocytopenia * For an intended LA implant, patient has a device implanted in the left atrial appendage (e.g., WATCHMAN or similar device) or a mechanical mitral valve * Patient has an atrial myxoma * Patient has pre-operative evidence of thrombus in the chamber in which the device is intended to be implanted * Patient has a history of stroke or transient ischemic attack within 6 months prior to the index procedure * History of systemic or pulmonary thromboembolism or deep vein thrombosis (DVT) within the last 6 months * Patient has a history of congenital heart disease, including known atrial septal defect that is not corrected (including during the LVAD implantation procedure) * Patient has severe mitral regurgitation (for an LA implant) or severe tricuspid regurgitation (for an RA implant) that is not intended to be corrected during the LVAD implantation * Patient has known allergy to stainless steel or titanium * Patient has noncardiac comorbidity that, in the opinion of the Principal Investigator, may limit life expectancy to less than 1 year * Patient is pregnant or intends to become pregnant prior to completion of all protocol follow-up requirements * Patient is participating in another investigational study that has not reached its primary endpoint * Intraoperative identification of any anatomical finding that would preclude safe access to, or closure of, the intended atrial chamber, or fixation of the device within the chamber including, but not limited to: 1. Identification of thrombus in the atrium in which the device will be implanted 2. Atrial anatomy deemed to be too thin or fragile to accept the implant 3. Epicardial adhesions or any intraoperative finding that would complicate access or closure of the atrium in which the device is intended to be implanted

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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.

Contacts and locations

Locations

  • Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH

    New York, New York, 10032, United States

  • Rabin Medical Center

    Petach Tikvah, Israel

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