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

Plain Language Summary

Simplified for easier understanding

This study is looking at how a minimally invasive heart procedure (to repair a leaky tricuspid valve — the valve on the right side of the heart) affects kidney function and physical ability in older adults. Tricuspid valve leakage is common in the elderly and can cause fluid buildup and fatigue. **You may be eligible if...** - You have severe symptomatic tricuspid valve insufficiency (a very leaky valve causing symptoms) - You have been referred for evaluation for a TriClip or TricValve procedure - You are over 18 years old and can provide consent - You are able to walk short distances, even with assistance **You may NOT be eligible if...** - You are on dialysis or have end-stage kidney disease - You have dementia or are unable to complete the study assessments - You have severe anemia (hemoglobin below 7 g/dL) - The procedure is being done with palliative (end-of-life comfort) intent only Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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