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Recruiting NCT07464106

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.

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Trial Parameters

Condition Tricuspid Regurgitation
Sponsor Robert Bosch Medical Center
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-02-01
Completion 2026-12
Interventions
Transcatheter edge-to-edge repair (TEER)

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Brief Summary

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.

Eligibility 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

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