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New sensor aims to cut hospital visits after heart valve fix

NCT ID NCT07442903

Disease control Sponsor: LMU Klinikum 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a small implantable sensor that monitors pressure in the lung artery for patients with severe tricuspid regurgitation and heart failure. The sensor is placed before a minimally invasive valve repair, and pressure readings are tracked for a year. The goal is to see if early detection of pressure changes can prevent hospitalizations. About 45 participants will be enrolled at a single center in Germany.

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)
What this could lead to
If successful, this could lead to better heart failure management after tricuspid valve repair, potentially reducing hospital stays and improving quality of life.
What could go wrong
This is a small pilot study (45 people) testing feasibility, not effectiveness. The device is new for right-sided heart failure, and results may not apply broadly. Risks include complications from sensor implantation.

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 45 people

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

Started

Feb 2026

Expected to finish

Mar 2029

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 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: * Age ≥18 years * Heart-failure NYHA class III despite optimal medical therapy * Heart failure related hospitalization in the 12 month prior to Cordella PA pressure sensor system implant * Planned tricuspid transcatheter edge-to-edge repair (T-TEER) or transcatheter tricuspid valve replacement (TTVR) * Willingness to participate and sign informed consent * Ability to perform PA pressure reading and telemonitoring Exclusion Criteria: * Cardiogenic shock or hemodynamic instability * Previous tricuspid intervention or surgery with repair or replacement of tricuspid leaflets * Active endocarditis * Tricuspid valve stenosis (baseline tricuspid valve in-flow gradient \> 5 mmHg) * Life expectancy of less than 12 months * Chronic renal failure requiring dialysis * Anatomic conditions impeding implantation of PA sensor * Acute pulmonary embolism or chronic thromboembolic pulmonary Hypertension (CTEPH)

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Conditions

The condition(s) this trial relates to.

heart failure tricuspid valve insufficiency

As listed by the trial registrant

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

Heart failure with severe tricuspid regurgitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • LMU Klinikum

    NOT_YET_RECRUITING

    Munich, Germany

  • LMU Munich

    RECRUITING

    München, Germany