RecruitingNCT07464106

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.


Sponsor

Robert Bosch Medical Center

Enrollment

100 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

Interventions

PROCEDURETranscatheter edge-to-edge repair (TEER)

Routine intervention, observational


Locations(1)

Robert Bosch Hospital

Stuttgart, Germany

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NCT07464106


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