Clinical trial NCT04610463: Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism
Official title: Evaluation of the Severity of Right to Left Shunt in Patent Foraneb Ovale Patients After Systemic Embolism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patent Foramen Ovale
Embolism
Keywords: Patent foramen ovale
Systemic Embolism
Cardiac Shunt
Right to left shunt
Hemodynamics
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Prospectively, precise and better identification of a risk group of these patients could lead to cost reduction of treatment. This cost reduction is crucial for young working-age patients who can be treated before a major irreversible brain injury occurs.

A parameter applicable in primary prevention saves the cost of ischemic stroke treatment and other systemic embolism; additionally it will contribute to cost reduction during aftercare treatment.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients aged ≥18 and \< 60 years
2. Cryptogenic stroke or Systemic embolization due to paradoxical embolization via Patent Foramen Ovale
3. The patient indicated for occlusion of PFO with catheter occluder

Exclusion Criteria:

1. Inability to perform spiroergometry
2. Inability to perform Transesophageal echocardiography (TEE)
3. Inability to perform proper Valsalva maneuver
4. Inability to understand and/or signed informed consent form
5. Contraindication of Patent Foramen Ovale occlusion by any medical reason or patient refusal

Primary outcomes:
measure: Quantification of R-L shunt namely
timeFrame: Up to 24 weeks
measure: Transesophageal Echocardiography examination before Patent foramen ovale closure
timeFrame: Up to 24 weeks (Prior subject's Patent foramen ovale closure)
measure: Evaluation of the severity of Right-Left shunt and comparison with atrial septal morphology
timeFrame: Up to 24 weeks
measure: Spiroergometric examination with the measurement of VO2max
timeFrame: 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder
measure: Spiroergometric examination with the measurement of SpO2
timeFrame: 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder
measure: Transesophageal Echocardiography routine examination after 6 months after Patent foramen ovale closure
timeFrame: Up to 24 weeks
measure: Influence of significant R-L shunt on exercise tolerance and quality of life of the patient
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno
city: Hradec Králové
country: Czechia
facility: I. interní kardioangiologická klinika, Fakultní nemocnice Hradec Králové
city: Ostrava
country: Czechia
facility: Fakultní nemocnice Ostrava
city: Praga
country: Czechia
facility: Nemocnice Na Homolce
city: Praha
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Praha
country: Czechia
facility: Institut klinické a experimentální medicíny (IKEM)
Study officials:
References: