Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults
Official 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.
Run by Robert Bosch Medical Center · NCT07464106 · Data updated 2026-11-12
This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Robert Bosch Medical Center Academic / other |
| Locations | 1 site (Stuttgart) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT07464106 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults referred for TriClip/TricValve screening with severe symptomatic tricuspid valve insufficiency who can consent and can walk short distances (with or without aids) are ideal candidates.
✕Probably not a fit
Patients on dialysis, with terminal kidney disease, severe anemia (Hb <7 g/dl), projected imminent death from palliative-intent intervention, or unable to comply with study assessments (e.g., advanced dementia) are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will follow older adults with severe symptomatic tricuspid valve insufficiency who are referred for transcatheter edge-to-edge repair (TEER) such as TriClip or TricValve. Participants will receive TEER as part of routine care and researchers will measure renal biomarkers, volume status, symptom burden, and physical capacity before and after the procedure. The study will also track motor function, daily activity, performance of activities of daily living, and quality of life using standardized tests and questionnaires. Outcomes will be compared over time within participants without randomization.
Why it matters
Potential benefit: If successful, the intervention could improve kidney function, reduce edema and symptoms, and increase physical capacity and quality of life for affected patients.
How similar studies have gone: Previous work with TEER devices has shown reductions in tricuspid regurgitation and improvements in symptoms and volume status, but effects specifically on renal function and frailty-related outcomes are less well-established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Robert Bosch Hospital
Stuttgart, Germany Recruiting
Study contacts
- Study coordinator: Andrea Schwab
- Email: Sekretariat-Nephrologie@rbk.de
- Phone: 071181010
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.