Active clinical trials for "Foramen Ovale, Patent"

A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices

Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS). However, the benefit of PFO-closure in elderly ESUS patients is not clear. The investigators designed this prospective register-based observational study to verify the efficacy of PFO-closure in elderly ESUS patients with high-risk PFO, older than 60 years

This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale for cryptogenic stroke.

The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.

Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.

The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise unexplained ischemic stroke.

To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale

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.

This is a multicenter prospective observational study aimed to asses whether a specific prothrombotic platelet phenotype can discern migraine patients with PFO (patent forame ovale) - related symptoms from patients with incidental PFO. The study will also explore additional distinguishing features of causal and incidental PFO using a metabolomics approach. It involves the enrollment of well-characterized patient cohorts and an ex vivo approach using comparative cell biology models that reproduce the most critical aspects of the clinical scenario.