NCT05820516招募中不适用
Cardiovascular, Renal and haemodynamIc Outcomes in Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation: an International Registry - CRITICAL INTERNATIONAL REGISTRY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The composite of all-cause mortality and HF rehospitalization at 6-month follow-up
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The composite of all-cause mortality and HF rehospitalization at 6-month follow-up
时间窗: 6-month follow-up
The composite of all-cause mortality and HF rehospitalization at 6-month follow-up
次要结局
- The composite of all-cause mortality and HF rehospitalization at 1-year follow-up(1-year follow-up)
- Cardiovascular mortality at 1-year follow-up(1-year follow-up)
- Number of HF rehospitalizations at 1-year follow-up(1-year follow-up)
- Number of unscheduled cardiology consultations resulting in changes in medical therapy at 6- month follow-up.(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.(6- month follow-up)
- Change in the dose of loop diuretics (in mg/day) at 6-month follow-up(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.(6- month follow-up.)
- Change in 6MWD and in peak oxygen uptake (VO2) at 6-month follow-up.(6- month follow-up.)
研究者
Marco De Carlo
M.D.
Azienda Ospedaliero, Universitaria Pisana
研究点 (2)
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