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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRobert Bosch Medical Center

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transcatheter edge-to-edge repair (TEER)

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators