Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism

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.

Study Overview

• Status: Recruiting
• Conditions: Embolism; Patent Foramen Ovale
• Intervention / Treatment: Diagnostic test: Cardiac flow measurement

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josef Šťásek; Phone Number: +420495832248; Email: josef.stasek@fnhk.cz
• Study Contact Backup: Name: Johana Krempová; Phone Number: +420601087319; Email: johana.krempova@fnhk.cz

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Not yet recruiting
    • Fakultni nemocnice Brno
    • Contact: Martin Poloczek; Phone Number: +420532232458; Email: martin.poloczek@fnbrno.cz
    • Principal Investigator: Martin Poloczek
  • Hradec Králové, Czechia, 50005
    • Recruiting
    • I. interní kardioangiologická klinika, Fakultní nemocnice Hradec Králové
    • Contact: Josef Šťásek; Phone Number: +420495832248; Email: josef.stasek@fnhk.cz
    • Principal Investigator: Josef Šťásek
  • Ostrava, Czechia, 70852
    • Not yet recruiting
    • Fakultni nemocnice Ostrava
    • Contact: Marian Branny; Phone Number: +420 597 374 024; Email: marian.branny@fno.cz
    • Principal Investigator: Marian Branny
  • Praga, Czechia, 15030
    • Not yet recruiting
    • Nemocnice Na Homolce
    • Contact: Martin Mates; Phone Number: +420 257 272 213; Email: martin.mates@homolka.cz
    • Principal Investigator: Martin Mates
  • Praha, Czechia, 12808
    • Not yet recruiting
    • Vseobecna Fakultni Nemocnice V Praze
    • Contact: Tomáš Kovárník; Phone Number: +420 224 96 2687; Email: Tomas.Kovarnik@vfn.cz
    • Principal Investigator: Tomáš Kovárník
  • Praha, Czechia, 14021
    • Recruiting
    • Institut klinicke a experimentalni mediciny (IKEM)
    • Contact: Michael Želízko; Phone Number: +420 236 055 113; Email: michael.zelizko@ikem.cz
    • Principal Investigator: Michael Želízko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard; Subjects indicated for patent foramen ovale closure to prevent a relapse of systemic embolism	Diagnostic test: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 weeks
Transesophageal Echocardiography examination before Patent foramen ovale closure	To evaluate the morphology of atrial septum	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	Up to 24 weeks
Spiroergometric examination with the measurement of VO2max	Detection of possible desaturation using the spiroergometric examination	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	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	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.	Up to 24 weeks

Collaborators and Investigators

• Sponsor: University Hospital Hradec Kralove

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Hemodynamics; Patent foramen ovale; Systemic Embolism; Cardiac Shunt; Right to left shunt
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Embolism and Thrombosis; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Embolism; Foramen Ovale, Patent
• Other Study ID Numbers: MEASURE-PFO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No