I36.1
Conditions
Interventions
Group 1: Patients with tricuspid regurgitation who are scheduled to undergo an intervention with a TriClip (Abbott, Chicago, IL, USA)
Pre-interventional assessments:
- Renal ultrasound, including rena
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: - Indication for tricuspid valve intervention (decision in interdisciplinary heart team) - Optimal medical therapy for tricuspid regurgitation and any heart failure - Consent to participate in the study
Exclusion criteria
Exclusion criteria: - Lack of patient consent - Statutory Care - Malignant tumor disease with an expected life expectancy of 65mmHg) - Left ventricular ejection fraction = 30% - Untreated significant structural disease of the left ventricle, which should be treated as a matter of priority - Permanent dialysis requirement - Contraindications to clip/prosthesis implantation -> Allergies to device components -> Allergies to contrast agents or vitamin K antagonists -> Deep vein thrombosis -> Unsuitable anatomy - Known tricuspid or mitral valve endocarditis in the last 12 months - Psychiatric illness or behavioral disorder including alcohol and drug abuse. - Liver cirrhosis Child C - Female patients of childbearing age - Current participation in another study with an investigational drug or device that would directly affect the treatment or outcome of the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What is the impact of tricuspid valve intervention on renal and hepatic congestion? Is there a difference between the intervention modalities? | — |
Secondary
| Measure | Time frame |
|---|---|
| - How do liver and kidney function change after tricuspid valve intervention? - Do liver and kidney function affect outcome (mortality, quality of life (measured with the MLHFQ)) after tricuspid valve intervention? - How do the gut microbiome and bacterial metabolites change after tricuspid valve interventions? | — |
Countries
Germany
Contacts
Public ContactSteffen Uhr
Universitätsmedizin Göttingen
Outcome results
None listed