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Heart valve fix may also shield kidneys in seniors

NCT ID NCT07464106

Disease control Sponsor: Robert Bosch Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a procedure to repair a leaky tricuspid heart valve can improve kidney function, reduce swelling, and boost physical activity in older adults. Researchers will follow 100 participants for changes in kidney health, walking ability, and daily function. The goal is to see if fixing the valve has benefits beyond the heart.

What this could mean

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

Active substance
transcatheter edge-to-edge repair (TEER) procedure
What this could lead to
If successful, this could show that fixing the tricuspid valve helps protect kidney function and improves mobility and daily living in older adults.
What could go wrong
This is an early observational study with only 100 participants, so results may not apply to everyone. The procedure itself carries risks like bleeding or infection.

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 100 people

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

Started

Feb 2025

Expected to finish

Dec 2027

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

The study population includes adult patients with severe symptomatic tricuspid valve insufficiency who are referred for TriClip/TricValve screening and are aged 18 years or older. Participants must be able to provide informed consent and have the capacity to walk short distances with the aid of mobility devices. Exclusion criteria include dialysis-dependent or terminal kidney disease, inability to comply with study-related assessments (e.g., due to dementia or cognitive decline), severe anemia (Hb \<7 g/dl), and the need for a tricuspid valve intervention with palliative intent, with a likely imminent death. Additionally, patients who are unable or unwilling to provide informed consent will be excluded from the study. This population represents individuals who are eligible for the intervention, while the exclusions ensure that participants can meaningfully engage in the study assessments and outcomes.

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: * Severe symptomatic tricuspid valve insufficiency and referral for TriClip/TricValve screening * Completed 18th year of life * Ability to consent * Able to walk short distances with aids Exclusion Criteria: * Dialysis-dependent/terminal kidney disease * Inability to comply with study-associated assessments (e.g., existing dementia) * Severe anemia (Hb \<7 g/dl) * Tricuspid valve intervention with palliative intent and likely imminent death * Lack of consent

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Conditions

The condition(s) this trial relates to.

cardio-renal syndrome Frailty tricuspid valve insufficiency

As listed by the trial registrant

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

Cardio-renal syndrome Frailty Tricuspid regurgitation Tricuspid valve insufficiency

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

  • Robert Bosch Hospital

    RECRUITING

    Stuttgart, Germany

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