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TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure

RecruitingNAAges 18 Years - anyAllLMU Klinikum
NCT07442903 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Tricuspid regurgitation (TR) is a severe and highly prevalent disease that leads to right-sided heart failure. The severity of TR is associated with increasing morbidity and mortality. While severe TR and right-sided heart failure have an impact on the quality of life and prognosis of the individual patient, repeat heart failure hospitalizations challenge limited hospital resources on an institutional level and stress the medical health care system on an economic level. Transcatheter valve interventions (TTVI) including transcatheter tricuspid edge-to-edge repair (T-TEER) and transcather tricuspid valve replacement (TTVR) have been established as effective techniques to safely reduce TR severity in many patients leading to significant improvements in quality-of-life and potential reduction of heart failure hospitalizations. However, the rate of heart failure hospitalizations remains elev

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * Heart-failure NYHA class III despite optimal medical therapy * Heart failure related hospitalization in the 12 month prior to Cordella PA pressure sensor system implant * Planned tricuspid transcatheter edge-to-edge repair (T-TEER) or transcatheter tricuspid valve replacement (TTVR) * Willingness to participate and sign informed consent * Ability to perform PA pressure reading and telemonitoring Exclusion Criteria: * Cardiogenic shock or hemodynamic instability * Previous tricuspid intervention or surgery with repair or replacement of tricuspid leaflets * Active endocarditis * Tricuspid valve stenosis (baseline tricuspid valve in-flow gradient \> 5 mmHg) * Life expectancy of less than 12 months * Chronic renal failure requiring dialysis * Anatomic conditions impeding implantation of PA sensor * Acute pulmonary embolism or chronic thromboembolic pulmonary Hypertension (CTEPH)
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What it tests

  • Pulmonary artery sensor system
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Where

2 sites
LMU Klinikum
Munich, Germany
LMU Munich
München, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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