Patent Foramen OvaleNCT04610463
Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism
A study testing Cardiac flow measurement in people with Patent Foramen Ovale and Embolism, run by University Hospital Hradec Kralove at 6 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patent Foramen Ovale, Embolism
- What is being tested?
- Cardiac flow measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesCzechia
- Study dates
- 25 Sep 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Czechia6 sites, 6 recruiting
- Not yet recruiting
Fakultní nemocnice Brno
Brno, 62500
Martin Poloczek, +420532232458, martin.poloczek@fnbrno.cz
Martin Poloczek
- Recruiting
I. interní kardioangiologická klinika, Fakultní nemocnice Hradec Králové
Hradec Králové, 50005
Josef Šťásek, +420495832248, josef.stasek@fnhk.cz
Josef Šťásek
- Not yet recruiting
Fakultní nemocnice Ostrava
Ostrava, 70852
Marian Branny, +420 597 374 024, marian.branny@fno.cz
Marian Branny
- Not yet recruiting
Všeobecná fakultní nemocnice v Praze
Prague, 12808
Tomáš Kovárník, +420 224 96 2687, Tomas.Kovarnik@vfn.cz
Tomáš Kovárník
- Recruiting
Institut klinické a experimentální medicíny (IKEM)
Prague, 14021
Michael Želízko, +420 236 055 113, michael.zelizko@ikem.cz
Michael Želízko
- Not yet recruiting
Nemocnice Na Homolce
Prague, 15030
Martin Mates, +420 257 272 213, martin.mates@homolka.cz
Martin Mates
About this study
Official title: Evaluation of the Severity of Right to Left Shunt in Patent Foraneb Ovale Patients After Systemic Embolism
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.
Read the 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.
- Conditions
- Patent Foramen Ovale, Embolism
- Being tested
- Cardiac flow measurement
- Keywords
- Patent foramen ovale, Systemic Embolism, Cardiac Shunt, Right to left shunt, Hemodynamics
- Medical subject headings
- Foramen Ovale, Patent, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac flow measurementDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard | Other | Subjects indicated for patent foramen ovale closure to prevent a relapse of systemic embolism Receives: Diagnostic Test: Cardiac flow measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of R-L shunt namely
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.
Measured: Up to 24 weeks
Transesophageal Echocardiography examination before Patent foramen ovale closure
To evaluate the morphology of atrial septum
Measured: Up to 24 weeks (Prior subject's Patent foramen ovale closure)
Evaluation of the severity of Right-Left shunt and comparison with atrial septal morphology
Is there a significant correlation between atrial septal morphology and the level of severity of cardiac shunt as a predictive factor for systemic embolism
Measured: Up to 24 weeks
Spiroergometric examination with the measurement of VO2max
Detection of possible desaturation using the spiroergometric examination
Measured: 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder
Spiroergometric examination with the measurement of SpO2
Detection of possible desaturation using the spiroergometric examination
Measured: 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder
Transesophageal Echocardiography routine examination after 6 months after Patent foramen ovale closure
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
Measured: Up to 24 weeks
Influence of significant R-L shunt on exercise tolerance and quality of life of the patient
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.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start25 Sep 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610463
- Sponsor's protocol ID
- MEASURE-PFO
- Status last verified
- Oct 2020
- First submitted
- 12 Jun 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Severity of Right to Left Shunt in Patent Foraneb Ovale Patients After Systemic Embolism
- ClinicalTrials.gov ID
- NCT04610463
- Acronym / sponsor ID
- MEASURE-PFO
- Conditions
- Patent Foramen Ovale, Embolism
- Keywords
- Patent foramen ovale, Systemic Embolism, Cardiac Shunt, Right to left shunt, Hemodynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard | Other | Diagnostic Test: Cardiac flow measurementSubjects indicated for patent foramen ovale closure to prevent a relapse of systemic embolism |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac flow measurementCatheterized 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). | Diagnostic test | Standard |
Primary outcome
Quantification of R-L shunt namely
Time frame: 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.
Transesophageal Echocardiography examination before Patent foramen ovale closure
Time frame: Up to 24 weeks (Prior subject's Patent foramen ovale closure)
To evaluate the morphology of atrial septum
Evaluation of the severity of Right-Left shunt and comparison with atrial septal morphology
Time frame: 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 VO2max
Time frame: 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder
Detection of possible desaturation using the spiroergometric examination
Spiroergometric examination with the measurement of SpO2
Time frame: 6 months after Patent foramen ovale closure by means of a Patent foramen ovale occluder
Detection of possible desaturation using the spiroergometric examination
Transesophageal Echocardiography routine examination after 6 months after Patent foramen ovale closure
Time frame: 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
Influence of significant R-L shunt on exercise tolerance and quality of life of the patient
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac flow measurement in people with Patent Foramen Ovale and Embolism, run by University Hospital Hradec Kralove at 6 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josef Šťásek (+420495832248, josef.stasek@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of R-L shunt namely (time frame: Up to 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.