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临床试验/NCT04068740
NCT04068740已完成不适用

Combining Multiple Complex Modelling Components to Create a Decision Support System for Heart Valve Disease

German Heart Institute0 个研究点目标入组 169 人开始时间: 2016年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
169
主要终点
Survival

研究概览

简要总结

Valvular Heart Disease currently affects 2.5% of the population, but is overwhelmingly a disease of the elderly and consequently on the rise. It is dominated by two conditions, Aortic Stenosis and Mitral Regurgitation, both of which are associated with significant morbidity and mortality, yet which pose a truly demanding challenge for treatment optimisation. By combining multiple complex modelling components, a comprehensive, clinically-compliant decision-support system will be developed to meet this challenge, by quantifying individualised disease severity and patient impairment, predicting disease progression, ranking the effectiveness of alternative candidate procedures, and optimising the patient-specific intervention plan.

In addition the DSS will improve knowledge of disease mechanisms by applying a holistic assessment of cardiovascular function that includes hemodynamic data at all cardiovascular compartments (ventricle, valve, vessels) and multiscale components that couple organ with cell function.

DSS may have major impact on patients with borderline indications for treatment (valve replacement/repair), complex hemodynamic conditions such as combined aortic-mitral valve disease and valve geometries that are subject to valve repair.

The target user of this Decision Support System is the healthcare professional, in this case the surgeon or cardiologist, who will make the decision on the nature and timing of the intervention. The major advance of this system over current practice is that it integrates and interprets all heterogeneous data available about the patient, integrates population data where needed, and provides a consistent, repeatable, quantitative and auditable record of the information that contributes to the decision process.

详细描述

Study design:

In the study a Decision Support System for aortic and mitral valve replacement/repair will be implemented and tested. Not all of the assessments listed will be performed on every patient, but sufficient to support the analysis processes.

The patients are enrolled in two subgroups:

  • Group 1: patients with aortic valve disease
  • Group 2: patients with mitral valve disease

The study has the following visits at all clinical centers:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient must give Informed Consent before being enrolled in the study.
  • Only elective cases will be eligible for inclusion. For mitral disease, patients were recruited with;
  • Severe degenerative or functional mitral regurgitation with the need for MVR according to the ESC/EACTS guidelines.
  • Degenerative mitral regurgitation
  • symptomatic patients with LVEF >30% and LVESD < 55mm (I B)
  • asymptomatic patients with LV dysfunction (LVESD ≥45 mm and/or LVEF ≤60% (I C)
  • asymptomatic patients with LVEF > 50%, new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary pressure at rest >50 mmHg) (IIa C)
  • patients with severe LV dysfunction (LVEF < 30% and LVESD > 55 mm) refractory to medical therapy with high likelihood of durable repair and low comorbidity. (IIa C) Functional mitral regurgitation
  • patients with severe MR (EROA >= 20 mm², Regurgitation volume > 30 ml) undergoing CABG, and LVEF >30% (I C)
  • patients with moderate MR undergoing CABG (IIa C)
  • symptomatic patients with severe MR, LVEF < 30 %, option for revascularisation, and evidence of viability (IIa C) For aortic valve disease, patients will be recruited with;
  • Severe acquired degenerative aortic valve disease with the need for SAVR or TAVI according to the ESC/EACTS guidelines Severe Aortic stenosis
  • symptomatic patients (I B)
  • patients undergoing CABG or surgery of ascending aorta or another valve (I C)
  • asymptomatic patients with abnormal exercise test (I C) / LVEF < 50% (I C) / blood pressure drop on exercise / peak gradient > 5.5 m/sec ( (IIa C)
  • symptomatic patients with low flow, low gradient (< 40mmHg) and normal LVEF (IIa C)

排除标准

  • Inability or unwillingness to give formal consent.
  • Emergency interventions
  • Active infective valvular disease or evidence of valvular damage by recent endocarditis
  • Valvular malfunction directly associated with aortic root disease
  • Aortic regurgitation as leading aortic valve pathology
  • Inability or unwillingness to complete follow up
  • MRI contraindications (Implanted pacemaker, Metallic foreign body, Severe claustrophobia)
  • CT contraindications (Known iodine or contrast agent allergy, Hyperhidrosis, Pregnancy)

结局指标

主要结局

Survival

时间窗: 6-12 months after treatment

Virtual treatment outcome: model based insufficiency or gradient across the valve

时间窗: 6-12 months after treatment

Clinical treatment outcome: Imaging based insufficieny or gradient across the valve

时间窗: 6-12 months after treatment

Probability (in %) of reaching of a patient-specific 6-minute walk distance

时间窗: 6-12 months after treatment

Patient-specific walk test distances are calulated based on known reference standards

6-minute walk test distances

时间窗: 6-12 months after treatment

distances in meters

次要结局

未报告次要终点

研究者

发起方
German Heart Institute
申办方类型
Other
责任方
Sponsor

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