Overview
International Registry to collect patients with severe TR undergoing TricValve implantation from multiple Italian and European centers, aimed at:
- Assessing the effect of TricValve implantation on cardiovascular and all-cause mortality, HF rehospitalization, renal function, functional capacity and quality of life.
- Clarifying the haemodynamic effects of TricValve implantation and investigating their pathophysiological implications.
Description
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.
Eligibility
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)
- 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
- Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter
- Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
- Liver cirrhosis Child C
- Female patient of child-bearing potential
- Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study