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

NCT04610463 | Unknown

• 1 other identifier: MEASURE-PFO
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

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.

Conditions

Patent Foramen Ovale; Embolism

Keywords

Patent foramen ovale; Systemic Embolism; Cardiac Shunt; Right to left shunt; Hemodynamics

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Standard

OTHER

Subjects indicated for patent foramen ovale closure to prevent a relapse of systemic embolism

Diagnostic Test: Cardiac flow measurement

Interventions

Cardiac flow measurement DIAGNOSTIC_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).

Standard

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (6)

Fakultní nemocnice Brno

Brno, 62500, Czechia

NOT YET RECRUITING

I. interní kardioangiologická klinika, Fakultní nemocnice Hradec Králové

Hradec Králové, 50005, Czechia

RECRUITING

Fakultní nemocnice Ostrava

Ostrava, 70852, Czechia

NOT YET RECRUITING

Všeobecná fakultní nemocnice v Praze

Prague, 12808, Czechia

NOT YET RECRUITING

Institut klinické a experimentální medicíny (IKEM)

Prague, 14021, Czechia

RECRUITING

Nemocnice Na Homolce

Prague, 15030, Czechia

NOT YET RECRUITING

MeSH Terms

Conditions

Foramen Ovale, Patent; Embolism

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Embolism and Thrombosis; Vascular Diseases

Central Study Contacts

Josef Šťásek

CONTACT

+420495832248; josef.stasek@fnhk.cz

Johana Krempová

CONTACT

+420601087319; johana.krempova@fnhk.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: October 30, 2020
• Study Start: September 25, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (6)