Registry for patients with severe tricuspid regurgitation after TricValve implantation
Cardiovascular, Renal and haemodynamIc Outcomes in Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation: an International Registry - CRITICAL INTERNATIONAL REGISTRY
This study is collecting information from patients with severe tricuspid regurgitation who are getting a TricValve implant to see how the procedure affects their heart health and overall quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero, Universitaria Pisana Academic / other |
| Locations | 1 site (Pisa, Pisa) |
| Trial ID | NCT05820516 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data from patients with severe tricuspid regurgitation who are undergoing TricValve implantation across multiple centers in Italy and Europe. It will assess the impact of the procedure on cardiovascular and all-cause mortality, heart failure rehospitalization, renal function, functional capacity, and quality of life. The study will involve a cohort of 100 patients, with evaluations conducted at baseline, discharge, and 30-day follow-up, including clinical, biohumoral, echocardiographic, and hemodynamic data collection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic severe tricuspid regurgitation and specific hemodynamic criteria.
Not a fit: Patients with mild or asymptomatic tricuspid regurgitation or those not suitable for TricValve implantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and quality of life for patients with severe tricuspid regurgitation.
How similar studies have performed: While this approach is observational, similar studies have shown promise in assessing the outcomes of transcatheter valve interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. The subject must be 18 years of age or older 2. The subject must be a patient with massive or torrential symptomatic tricuspid regurgitation demonstrated by echocardiography with significant backflow in the IVC and/or SVC and with a v-wave ≥ 25 mmHg as demonstrated by right heart catheterization (measured in the IVC and/or SVC 2-4 cm above/ below right atrium (RA) inflow) within 8 weeks prior to the implantation 3. Suitable for TricValve Transcatheter Bicaval Valves System implantation according to anatomic criteria by computed tomography (CT)inserire la parte retrospettiva ossia i pazienti che già hanno avuto l'impianto 4. The subjects must have severe, tricuspid regurgitation leading to New York Heart Association (NYHA) class III or IV 5. Distance covered in 6-minute walk test (6MWT) ≥ 60m 6. Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfil all of the expected requirements of the clinical protocol Exclusion Criteria 1. Known significant intracardiac shunt (e.g. ventricular septal defect) or congenital structural heart disease based on heart team decision 2. Requirement for other elective cardiac procedures e.g. Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) up to 90 days after the procedure or 30 days before the procedure 3. Right ventricular failure (TAPSE ≤13 mm) 4. Systolic pulmonary arterial pressure \> 65 mmHg as assessed by Doppler echocardiography 5. Life expectancy less than one year 6. Cerebro-vascular event within the past 3 months 7. History of mitral/tricuspid endocarditis within the last 12 months 8. Patient has untreated significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis) 9. Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count \<90k) 10. Documented evidence of significant renal dysfunction (serum creatinine \> 3.0mg/dl) or on any form of dialysis at time of screening within the last 4 weeks 11. Contraindication or known allergy to device's components, anti-coagulation therapy with vitamin K antagonists or contrast media that cannot be adequately pre-treated 12. Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days) 13. Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study
Where this trial is running
Pisa, Pisa
- Azienda Ospedaliero Universitaria Pisana — Pisa, Pisa, Italy (Recruiting)
Study contacts
- Study coordinator: Marco De Carlo, MD
- Email: marcodecarlo@gmail.com
- Phone: +39050995326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.