Evaluation of the Severity of Right to Left Shunt in Patent Foraneb Ovale Patients After Systemic Embolism
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Transesophageal Echocardiography routine examination after 6 months after Patent foramen ovale closure
研究概览
简要总结
The aim of the project is to identify new risk indicators of PFO. The evaluation of the R-L shunt is based on the newly developed precise measurement technique. Moreover, this measurement of R-L shunt is feasible in a case when R-L shunt is present only intermittently. Multicentric study with 150 patients.
详细描述
The aim of the proposed project is to identify new risk indicators of PFO. The evaluation of the R-L shunt is based on the newly developed precise measurement technique. Moreover, this measurement of R-L shunt is feasible in a case when R-L shunt is present only intermittently.
Detection and quantification of R-L shunt will be realized by the original INNTHERM® ® system (Innova Medical s.r.o., Velká Dobrá). This system is based on the principle of thermodilution.
The basic assumption of our study is the hypothesis, that the size of the R-L shunt (and especially its maximum size during intra-abdominal pressure increase) is a risk factor for the development of paradoxical embolism (from pulmonary to systemic circulation). The most critical consequence of paradoxical embolism is the development of ischemic stroke.
Such measurement with an unequivocal accuracy has never been done so far, due a lack of technology precise enough.
Precise quantification of R-L shunt will allow a more accurate prediction of high-risk patients, especially after correlation with commonly used methods. PFO is now an indication for implantation of percutaneous occlusion device only in case of secondary prevention of stroke, i.e. in a group of patients who have had an ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥18 and < 60 years
- •Cryptogenic stroke or Systemic embolization due to paradoxical embolization via Patent Foramen Ovale
- •The patient indicated for occlusion of PFO with catheter occluder
排除标准
- •Inability to perform spiroergometry
- •Inability to perform Transesophageal echocardiography (TEE)
- •Inability to perform proper Valsalva maneuver
- •Inability to understand and/or signed informed consent form
- •Contraindication of Patent Foramen Ovale occlusion by any medical reason or patient refusal
结局指标
主要结局
Transesophageal Echocardiography routine examination after 6 months after Patent foramen ovale closure
时间窗: Up to 24 weeks
To evaluate results 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder with a routine examination of Transesophageal Echocardiography
Transesophageal Echocardiography examination before Patent foramen ovale closure
时间窗: Up to 24 weeks (Prior subject's Patent foramen ovale closure)
To evaluate the morphology of atrial septum
Spiroergometric examination with the measurement of VO2max
时间窗: 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder
Detection of possible desaturation using the spiroergometric examination
Quantification of R-L shunt namely
时间窗: Up to 24 weeks
Right-to Left shunt will be measured and quantified using by the novel system for measurement of Cardiac flow- Inntherm. We will obtain these hemodynamics parameters: Systemic blood flow (SBF) pulmonary blood (PBF) Cardiac index (CI), ration of QP/QS. Right to left shunt will be quantified in liters per minutes as well as % of SBF and % of PBF. We will evaluate R-L shunt in normal conditions as well as after inducible Valsalva maneuver. Each patient will fill EQ-5D at the beginning of the study and Then 24 weeks after PFO closure.
Evaluation of the severity of Right-Left shunt and comparison with atrial septal morphology
时间窗: Up to 24 weeks
Is there a significant correlation between atrial septal morphology and the level of severity of cardiac shunt as a predictive factor for systemic embolism
Spiroergometric examination with the measurement of SpO2
时间窗: 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder
Detection of possible desaturation using the spiroergometric examination
Influence of significant R-L shunt on exercise tolerance and quality of life of the patient
时间窗: Up to 24 weeks
To judge if the closure of Patent foramen ovale especially by the group of patients with significant R-L shunt may influence exercise tolerance and quality of patient life. Precise results of quantification of R-L Shunt will significantly correlated with a possible complications of PFO - systemic embolization, desaturation syndromes.
次要结局
未报告次要终点