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.
Recruiting · NCT07464106 · Observational (researchers observe without assigning treatment) · Lead sponsor: Robert Bosch Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Transcatheter edge-to-edge repair (TEER)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Robert Bosch Hospital - Stuttgart, Germany