Actively Recruiting

Age: 18Years +
All Genders
ID07464106

Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults

Led by Robert Bosch Medical Center · Updated on 2026-03-11

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of interventional treatments on older adults with symptomatic, severe tricuspid valve insufficiency. The study focuses on whether these treatments can improve kidney function and reduce related biomarkers. It also aims to assess changes in swelling, symptom severity, physical capacity, motor skills, daily activities, participation, and overall quality of life in these patients. The intervention under observation is the transcatheter edge-to-edge repair (TEER), a procedure used to treat tricuspid valve insufficiency. Participants will be assessed before and after this intervention. The study collects data at baseline, 6 months, 12 months, and 24 months to monitor changes over time. Participants will undergo various evaluations including kidney function tests, physical activity monitoring with the activPAL4 device, and exercise capacity measured by the 6-minute walk test. Additional assessments cover body mass index, hospitalizations due to heart failure, quality of life questionnaires, frailty scales, cognitive and emotional tests, muscle strength, and mobility. The study also tracks kidney-related outcomes such as acute kidney injury, dialysis initiation, and chronic kidney disease prevalence. Monitoring occurs throughout the study period to understand the impact of the intervention on multiple health aspects.

CONDITIONS

Brief Title

Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Dialysis-dependent or terminal kidney disease
  • Inability to comply with study-associated assessments, such as existing dementia
  • Severe anemia with hemoglobin less than 7 g/dl
  • Tricuspid valve intervention with palliative intent and likely imminent death
  • Lack of consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of intervention

Participants undergo the routine transcatheter edge-to-edge repair (TEER) intervention for tricuspid valve insufficiency.

1 visit (in-person)

Long-term Monitoring

Duration - 24 months

Participants are monitored for changes in kidney function, physical activity, and other health outcomes over time.

4 visits at Baseline, 6 months, 12 months, and 24 months

Trial Site Locations

Total: 1 location

1

Robert Bosch Hospital

Stuttgart, Germany

Actively Recruiting

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Research Team

A

Andrea Schwab

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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