RecruitingNANCT07442903

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

ConditionHeart Failure With Severe Tricuspid Regurgitation
InterventionPulmonary artery sensor system
PhaseNA
StatusRecruiting
Participants45
Est. Completion1 Mar 2029
Last Updated8 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

Germany
View Registry Entry

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