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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.

Recruitingn/aAges 18 Years - anyAllRobert Bosch Medical Center
NCT07464106 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The hypothesis is that renal function will improve following tricuspid valve intervention. A reduction in renal biomarkers is also expected. Furthermore, based on previous assessments, it is anticipated that there will be an improvement in volume status (reduced edema), symptom burden, and physical capacity in patients. Additionally, the study will assess the impact of the intervention on functional parameters such as motor capacity, physical activity, performance of activities of daily living, and ultimately, participation and quality of life.

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📋 Eligibility rules (as published)
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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What it tests

  • Transcatheter edge-to-edge repair (TEER)
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Where

1 site
Robert Bosch Hospital
Stuttgart, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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