Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation

Study Design

Type of study: Non-profit, multi-center, observational, prospective cohort study (with retrospective inclusion of the first cases performed)

Patient population: 100 patients

Date of beginning of enrollment: April 1st, 2023 (plus inclusion of patients treated since 2022)

Duration of the study: 12 months

All patients enrolled will undergo serial evaluations (Figure 1).

• At Baseline we will collect (see eCRF):

• Clinical data regarding medical history, clinical status and medications;
• Biohumoral data (blood and urine chemistry);
• Haemodynamic data (Right Heart Catheterization);
• Echocardiographic data including Comprehensive 2D and Doppler Transtoracic Echocardiography and Transoesophageal Echocardiography;
• Anatomical data (Cardiac CT).
• At the time of procedure we will collect (see eCRF):

• Procedural data including the occurrence of peri-procedural complications;
• Haemodynamic data (Right Heart Catheterization).
• At discharge we will collect (see eCRF):

• Clinical data regarding clinical status and medications;
• Biohumoral data (blood and urine chemistry);
• Echocardiographic data including comprehensive 2D and Doppler Transtoracic Echocardiography;
• Peri-procedural data including the occurrence of peri-procedural complications.
• At 30-day follow-up we will collect (see eCRF):

• Clinical data regarding medical history, clinical status and medications;
• Biohumoral data (blood and urine chemistry);
• Echocardiographic data including comprehensive 2D and Doppler Transtoracic Echocardiography;
• At 6-month follow-up we will collect (see eCRF):

• Clinical data regarding medical history, clinical status and medications;
• Biohumoral data (blood and urine chemistry);
• Echocardiographic data including comprehensive 2D and Doppler transthoracic echocardiography;
• Haemodynamic data (Right Heart Catheterization), if clinically indicated.
• At 1-year follow-up we will collect (see eCRF):

• Clinical data regarding medical history, clinical status and medications;
• Biohumoral data (blood and urine chemistry);
• Echocardiographic data including Comprehensive 2D and Doppler Transtoracic Echocardiography;
• Haemodynamic data (Right Heart Catheterization), if clinically indicated.

Inclusion criteria

• The subject must be 18 years of age or older
• 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
• 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
• The subjects must have severe, tricuspid regurgitation leading to New York Heart Association (NYHA) class III or IV
• Distance covered in 6-minute walk test (6MWT) ≥ 60m
• 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

• Known significant intracardiac shunt (e.g. ventricular septal defect) or congenital structural heart disease based on heart team decision
• 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
• Right ventricular failure (TAPSE ≤13 mm)
• Systolic pulmonary arterial pressure > 65 mmHg as assessed by Doppler echocardiography
• Life expectancy less than one year
• Cerebro-vascular event within the past 3 months
• History of mitral/tricuspid endocarditis within the last 12 months
• Patient has untreated significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)
• Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)
• 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
• Contraindication or known allergy to device's components, anti-coagulation therapy with vitamin K antagonists or contrast media that cannot be adequately pre-treated
• Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
• Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study