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| Name | Class |
|---|---|
| University of Ljubljana, Faculty of Medicine | OTHER |
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International medical centre Medicor from Slovenia has reported 306 successful percutaneous closures of patent foramen ovale (PFO) from October 2006 till June 2022. The investigators are going to follow-up the participants clinically and with contrast transthoracic echocardiography (TTE) to define the percentage of functional percutaneous closure. The latter is defined with the number (ten or less) of contrast-bubbles in the left atrium during Valsalva maneuver and contrast (agitated saline) application. The clinical follow-up will show the recurrence of embolic events (cerebrovascular insults, transient ischemic attacks) after percutaneous closure. In addition all of the participants are going to be screened for atrial fibrillation. The patients with moderate residual shunts (more than ten bubbles in the left atrium) will then according to the protocol have a transesophageal echocardiogram (TEE) to show the eventual mechanism of the shunt. If the TEE will not show any signs of a residual shunt, the patients will undergo a computed tomography angiogram (CTA) of the pulmonary circulation to exclude arterio-venous fistulas as a cause of the shunt seen on TTE. The investigators will also show the comparison in functional closure between classic and alternative device occluders.
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| Measure | Description | Time Frame |
|---|---|---|
| CVI | Cerebrovascular insult | From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. |
| TIA | Transient ischemic attack | From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. |
| Death | From cardiac and non-cardiac reasons | From date of percutaneous closure until the date of death from any cause. |
| Measure | Description | Time Frame |
|---|---|---|
| AF | Atrial fibrillation | From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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We included patients who met our inclusion criteria, regardless of age and gender.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maja Rojko, MD | Contact | 041847572 | 00386 | rojko.maja@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marjeta Zorc, MD, PhD | MC Medicor | Study Chair |
| Marko Noc, MD, PhD | MC Medicor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MC Medicor | Recruiting | Ljubljana | 1000 | Slovenia |
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During the period of 24 months.
The Clinical Trials ID of the study.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 17, 2026 | |
| Reset | May 8, 2026 | |
| Release | May 10, 2026 | |
| Reset | Jun 3, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 17, 2026 | May 8, 2026 | |||
| May 10, 2026 |
| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| D000083262 | Embolic Stroke |
| D001281 | Atrial Fibrillation |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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| Jun 3, 2026 |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002545 | Brain Ischemia |