NCT05820516

Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation

Cardiovascular, Renal and haemodynamIc Outcomes in Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation: an International Registry - CRITICAL INTERNATIONAL REGISTRY

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Azienda Ospedaliero, Universitaria Pisana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Severe Tricuspid Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	TricValve implantation	TricValve implantation

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2023-04-19
• Last updated: 2025-01-29

Locations

1 site across 1 country: Italy