Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of intervention
Participants undergo the routine transcatheter edge-to-edge repair (TEER) intervention for tricuspid valve insufficiency.
1 visit (in-person)
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
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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