Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism (NCT04610463) | Clinical Trial Compass
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Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism
Czechia150 participantsStarted 2020-09-25
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Inability to perform spiroergometry
. Inability to perform Transesophageal echocardiography (TEE)
. Inability to perform proper Valsalva maneuver
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of R-L shunt namely
Timeframe: Up to 24 weeks
2
Transesophageal Echocardiography examination before Patent foramen ovale closure
Timeframe: Up to 24 weeks (Prior subject's Patent foramen ovale closure)
3
Evaluation of the severity of Right-Left shunt and comparison with atrial septal morphology
Timeframe: Up to 24 weeks
4
Spiroergometric examination with the measurement of VO2max
Timeframe: 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder
5
Spiroergometric examination with the measurement of SpO2
Timeframe: 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder
6
Transesophageal Echocardiography routine examination after 6 months after Patent foramen ovale closure
Timeframe: Up to 24 weeks
7
Influence of significant R-L shunt on exercise tolerance and quality of life of the patient