Severe Tricuspid Valve Regurgitation Clinical Trial
Official title:
Cardiovascular, Renal and haemodynamIc Outcomes in Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation: an International Registry - CRITICAL INTERNATIONAL REGISTRY
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.
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. ;