Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism
NCT ID: NCT04610463
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-09-25
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Standard
Subjects indicated for patent foramen ovale closure to prevent a relapse of systemic embolism
Cardiac flow measurement
Catheterized hemodynamics evaluation - a measurement of systemic flow and pulmonary flow, R-L shunt, L-R shunt using the INNTHERM® system, prior to PFO closure using a common PFO-occluder (within one catheterization intervention).
Interventions
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Cardiac flow measurement
Catheterized hemodynamics evaluation - a measurement of systemic flow and pulmonary flow, R-L shunt, L-R shunt using the INNTHERM® system, prior to PFO closure using a common PFO-occluder (within one catheterization intervention).
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
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University Hospital Hradec Kralove
OTHER
Responsible Party
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Locations
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Fakultní nemocnice Brno
Brno, , Czechia
I. interní kardioangiologická klinika, Fakultní nemocnice Hradec Králové
Hradec Králové, , Czechia
Fakultní nemocnice Ostrava
Ostrava, , Czechia
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
Institut klinické a experimentální medicíny (IKEM)
Prague, , Czechia
Nemocnice Na Homolce
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Martin Poloczek
Role: primary
Josef Šťásek
Role: primary
Marian Branny
Role: primary
Tomáš Kovárník
Role: primary
Michael Želízko
Role: primary
Martin Mates
Role: primary
Other Identifiers
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MEASURE-PFO
Identifier Type: -
Identifier Source: org_study_id