First-in-man TRICENTO G2 Transcatheter Valve for Tricuspid Regurgitation
Official title: First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Run by Medira GmbH · NCT07536724 · Data updated 2026-11-12
This trial tests whether the TRICENTO G2 transcatheter valve can safely improve symptoms for adults with severe or greater tricuspid regurgitation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Medira GmbH Industry-sponsored |
| Locations | 2 sites (Tashkent and 1 other locations) |
| Status | Recruiting |
| Started | September 29, 2026 |
| Main results expected | November 2027 |
| Study ends | November 2027 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07536724 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with symptomatic severe or greater tricuspid regurgitation who are anatomically suitable for TRICENTO G2 Bioprosthesis and able to follow study procedures.
✕Probably not a fit
Patients with unsuitable anatomy, high atrial pressures, or other contraindications may not benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This first-in-man study evaluates the safety and performance of the TRICENTO G2 TVSTR device implanted via a minimally invasive approach in adults with symptomatic severe tricuspid regurgitation. Participants undergo implantation and are followed for up to one year with visits at baseline, 30 days, 3 months, 6 months, and 12 months. The study aims to determine if the valve improves symptoms and maintains device safety. Eligibility requires severe TR with reduced functional capacity and anatomical suitability confirmed by imaging and heart-team review. Exclusion criteria include unfavorable venous dimensions, very high right atrial pressures, and other hemodynamic considerations.
Why it matters
Potential benefit: If successful, patients may experience improved symptoms and quality of life from better tricuspid valve function.
How similar studies have gone: Previous transcatheter approaches for tricuspid regurgitation have shown potential benefits but first-in-man data for this specific system are needed to establish safety and performance.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with symptomatic tricuspid regurgitation (TR), graded as severe or greater (accord. to TR 5-Tier Grading System TVARC) * Patients with TR leading to NYHA class II, III or IV or clinical signs of right heart failure * Patients suitable for implantation of the TRICENTO G2 Bioprosthesis according to anatomical and clinical criteria assessed by computed tomography, echocardiography and/or right heart catheterization (confirmed by a heart team) * Patients receiving optimal medical treatment for underlying diseases * Patients being able to give informed consent * Patients empowered and willing to comply with the study procedures Exclusion Criteria: * Superior vena cava diameter \< 22.9 mm or \> 37.1 mm (perimeter derived) * Inferior vena cava diameter \< 27.9 mm or \> 42.9 mm (perimeter derived) * Right atrium cavity height \< 55 mm or \> 80 mm (direct path between caval ostia) * Peak right atrial pressure \> 50 mmHg * Systolic pulmonary artery pressure (sPAP) \> 60 mmHg * Pulmonary Vascular Resistance \> 3 Wood units * Vascular conditions that do not allow for insertion and access routing of the 26 Fr Delivery System to the intended implantation site * Known hypersensitivity, allergy or contraindication to the device's materials, e.g. Nitinol * Echocardiographic evidence of intra-cardiac thrombus or vegetation * Relevant tricuspid valve stenosis (e.g. determined by a mean diastolic transvalvular gradient \> 5 mmHg at a normal heart rate) * RV dysfunction determined by multiple of the following * TAPSE \< 10mm * RVOT VTI \< 10 cm * TASV/S' \< 11.5 cm/s * RV FAC \< 30 % * RV EF \< 35 % * Severe uncontrolled hypertension (systolic BP ≥ 180 mmHg and/or diastolic BP ≥ 110 mmHg) * LV function defined by LVEFbp \< 25 % * Indication for intervention for any of the other heart valves or for open cardiac surgery * Any PCI or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure * Myocardial infarction within the 30 days prior to the index procedure * Evidence of a present thrombosis of the lower venous system * Medical devices present in the intended implantation site that are expected to interfere with the access, proper deployment and/or function of the prosthesis * Evidence of active endocarditis or other acute infections * Known hypersensitivity or contraindication to anticoagulation, anti-platelet medication, or contrast media, which cannot be adequately pre-medicated * Patients on chronic dialysis * Thrombophilia * Bleeding diathesis or coagulopathy * Women of childbearing potential, defined as females who have experienced menarche and who are not permanently sterile or not postmenopausal (≥12 consecutive months without menses without an alternative medical cause) * Patients with any known life-threating, non-cardiac disease that will limit life expectancy of the patient to less than one year
Where it's running
-
Republican Specialized Cardiology Scientific and Practical Medical Center of Cardiology
Tashkent, Uzbekistan Recruiting -
Ministry of Healthcare of the Republic of Uzbekistan "Republican Research Centre of Emergency Medicine"
Tashkent, Uzbekistan Not yet recruiting
Study contacts
- Study coordinator: Laura Klink, M. Sc.
- Email: laura.klink@lsmedcap.com
- Phone: +49 (0) 151 14140423
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.