Transcatheter tricuspid repair or replacement with implanted pulmonary-artery pressure monitoring
Official title: Heart Failure Monitoring Using Continuous Pulmonary Arterial or Central Venous Pressure Measurement in Patients Undergoing Transcatheter Tricuspid Valve Intervention: a Pilot and Feasability Study
Run by LMU Klinikum · NCT07442903 · Data updated 2026-11-12
This project will test whether adding a small implanted pulmonary-artery pressure sensor and remote monitoring after transcatheter tricuspid repair or replacement helps people with severe tricuspid regurgitation and heart failure have fewer hospital stays.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | LMU Klinikum Academic / other |
| Locations | 2 sites (Munich and 1 other locations) |
| Status | Recruiting |
| Started | February 17, 2026 |
| Main results expected | March 2029 |
| Study ends | March 2029 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT07442903 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with severe tricuspid regurgitation who are NYHA class III despite optimal medical therapy, had a heart-failure hospitalization in the past year, are scheduled for T‑TEER or TTVR, and can perform PA pressure readings and telemonitoring.
✕Probably not a fit
Patients in cardiogenic shock, with active endocarditis, significant tricuspid stenosis, prior tricuspid surgery, on dialysis, with life expectancy under 12 months, or with anatomy preventing PA sensor implantation are unlikely to receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with severe tricuspid regurgitation and NYHA class III heart failure who had a heart-failure hospitalization in the prior 12 months and are planned for transcatheter tricuspid edge-to-edge repair (T‑TEER) or transcatheter tricuspid valve replacement (TTVR) are enrolled. At or around the time of the transcatheter procedure participants receive a Cordella pulmonary-artery (PA) pressure sensor implant and submit daily pressure readings via telemonitoring. Treating clinicians use PA pressure trends to guide remote adjustments of heart-failure therapy with the aim of reducing repeat hospitalizations and improving quality of life. Safety and feasibility endpoints include device- and procedure-related complications and successful long-term hemodynamic monitoring.
Why it matters
Potential benefit: If successful, patients may experience fewer heart-failure hospitalizations and better symptom control through earlier, pressure-guided treatment changes.
How similar studies have gone: Prior studies have shown pulmonary-artery pressure sensors can reduce heart-failure hospitalizations and transcatheter tricuspid interventions reduce TR severity, but routine PA monitoring specifically combined with tricuspid intervention is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
LMU Munich
München, Germany Recruiting -
LMU Klinikum
Munich, Germany Not yet recruiting
Study contacts
- Study coordinator: Thomas Stocker, MD
- Email: thomas.stocker@med.uni-muenchen.de
- Phone: +498944000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.