Registry for patients with severe tricuspid regurgitation after TricValve implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Azienda Ospedaliero Universitaria Pisana
  Pisa, Pisa, Italy Recruiting

Study contacts

• Study coordinator: Marco De Carlo, MD
• Email: marcodecarlo@gmail.com
• Phone: +39050995326

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

  This trial tests the Laplace TTVR System to see if it safely and effectively treats adults with severe tricuspid regurgitation.

  Recruiting at 2 sites Laplace Interventional, Inc · Tulsa, Oklahoma and 1 other locations · NCT07687485

• TruGamma tricuspid valve replacement for high-risk patients

  This trial tests the TruGamma tricuspid valve replacement system in high-risk patients with severe tricuspid regurgitation to see if it is safe and helps symptoms when added to standard medical care.

  Recruiting Jiangsu Trulive Medical Co., Ltd · Beijing, Beijing Municipality · NCT07691307

• Vyne TriNova Transcatheter Tricuspid Valve Replacement study for severe tricuspid regurgitation

  This trial tests the VDyne TriNova system in adults with symptomatic severe tricuspid regurgitation to see if it is safe and helps heart symptoms compared with an alternative device.

  Recruiting at 12 sites VDyne, Inc. · Phoenix, Arizona and 11 other locations · NCT07516444

• Lead-related tricuspid valve leakage after first-time pacemaker or ICD implantation

  This project will see if a new transvenous pacemaker or ICD lead causes new or worse tricuspid valve regurgitation in people getting their first device.

  Recruiting Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW · Bad Oeynhausen, North Rhine-Westphalia · NCT07342036

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

• Assessment of the inQB8 Tricuspid Valve Replacement System

  This study is testing a new valve replacement system to see if it can safely help people with severe tricuspid valve problems feel better.

  Recruiting at 8 sites inQB8 Medical Technologies, LLC · Los Angeles, California and 7 other locations · NCT06611579

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.