Heart Failure Monitoring Using Continuous Pulmonary Arterial or Central Venous Pressure Measurement in Patients Undergoing Transcatheter Tricuspid Valve Intervention: a Pilot and Feasability Study
Sponsor: LMU Klinikum
Trial Details
| Condition | Heart Failure With Severe Tricuspid Regurgitation |
| Intervention | Pulmonary artery sensor system |
| Phase | NA |
| Status | Recruiting |
| Participants | 45 |
| Est. Completion | 1 Mar 2029 |
| Last Updated | 8 May 2026 |
Primary Outcome
Change in implantable pulmonary artery (PA) pressure sensing (IPAPS) before TTVI compared to one month after TTVI
Eligibility Criteria
Inclusion Criteria
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)
Trial Sites
Countries
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