Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство TricValve implantation
  TricValve implantation

Первичные конечные точки

• The composite of all-cause mortality and HF rehospitalization at 6-month follow-up [Срок оценки: 6-month follow-up]

Вторичные конечные точки (8)

• The composite of all-cause mortality and HF rehospitalization at 1-year follow-up [Срок оценки: 1-year follow-up]
• Cardiovascular mortality at 1-year follow-up [Срок оценки: 1-year follow-up]
• Number of HF rehospitalizations at 1-year follow-up [Срок оценки: 1-year follow-up]
• Number of unscheduled cardiology consultations resulting in changes in medical therapy at 6- month follow-up. [Срок оценки: 6- month follow-up]
• Change in New York Hearts Association (NYHA) functional class and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 6-month and 1-year follow-up. [Срок оценки: 6- month follow-up]
• Change in the dose of loop diuretics (in mg/day) at 6-month follow-up [Срок оценки: 6- month follow-up.]
• Progression of kidney disease, defined as the composite of end-stage kidney disease, a decrease in eGFR to <10 ml/min/1.73 m2, a decrease in eGFR ≥40% from baseline, and death from renal causes at 6-month follow-up. [Срок оценки: 6- month follow-up.]
• Change in 6MWD and in peak oxygen uptake (VO2) at 6-month follow-up. [Срок оценки: 6- month follow-up.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Azienda Ospedaliero Universitaria Pisana — Pisa

Идентификаторы

NCT: NCT05820516 · CRITICAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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