Active clinical trials for "Foramen Ovale, Patent"

This is a prospective multicenter clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent foramen ovale (PFO).

The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

The primary objective of this study is to demonstrate the safety and efficacy of the PFX Closure System when utilized for patent foramen ovale (PFO) in patients suffering from cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief neurological dysfunction), migraine or decompression illness.

The purpose of the study is to collect more data about performance and safety of the device called "IrisFITTM PFO occluder". This data will be used to help more patients who will accept treatment with this device in the future. Patients will undergo routine examination, procedure and follow-up. Related data will be collected and kept in a way that patient info is well protected.

Patent foramen ovale (PFO) is a prevalent cause of ischemic stroke and transient ischemic attack (TIA) in young patients. Its role as a cause of cerebrovascular events in the older population is more controversial because of other competing causes are more frequent in the elderly. Recent randomized controlled trials (RCTs) have shown that PFO closure is associated with a 59% relative risk reduction in the risk of recurrent ischemic stroke. As such, the number of PFO closure procedures are expected to increase substantially in the upcoming years. Real world data (RWD) informing on the medical management, the risk of stroke recurrence, incident atrial fibrillation, and other outcomes in stroke patients with PFO, with and without PFO closure, will become crucial for understanding how results from RCTs are translated into clinical practice globally. The IMPROVE (International Multicenter Patent foRamen OVale & strokE) Registry is an observational, multicenter, international registry of men and women with an ischemic stroke or TIA. The aim is to enroll 8,800 patient-years at ≥50 sites in ≥20 countries. The IMPROVE Registry will provide important information about the management and related outcomes of patients with ischemic stroke or TIA and PFO throughout different regions of the world and across a wide spectrum of healthcare systems.

To evaluate the performance of patent foramen ovale (PFO) device developed by Lifetech Technology (Shenzhen) Co., LTD

A patent foramen ovale (PFO) is found more frequently in patients with an ischemic stroke than in control subjects. Therapeutic options to prevent stroke recurrence include antiplatelet drugs, oral anticoagulants, and transcatheter closure of the foramen. However, there are no published studies showing convincingly the superiority of any one of these strategies in preventing stroke recurrence. The aim of this randomized clinical trial is to assess whether chronic anticoagulation on the one hand and transcatheter on the other hand are superior to chronic antiplatelet therapy in preventing stroke recurrence.

This study is a multi-center, prospective, single-arm, non-significant risk (NSR) device study in which up to 150 evaluable subjects with suspicion of embolic stroke of undetermined source (ESUS) will be evaluated with NB-IS TCD and standard of care TTE to screen for right to left shunt (RLS) or patent foramen ovale (PFO). Additionally, up to 150 evaluable subjects will be evaluated with NB-IS TCD and standard of care TEE.

Patent foramen ovale arises from the incomplete postnatal fusion of the septum primum and secundum and can cause paradoxical embolism in adults. In case of cerebral ischemic stroke, the correlation with the patent foramen ovale is based on probabilistic approach. For this reason, continuous research is indispensable, especially according to new approaches, to offer tools capable of guiding in case of adverse event with greater certainty and even better to prevent it. Thus, this study aims to: 1) evaluate the microstructural brain damage through advanced MRI analysis in patients with patent foramen ovale; 2) evaluate how much the degree of the shunt can affect brain damage. In order to do this, this study aims to evaluate advanced brain imaging in a cohort of patients with patent foramen ovale to identify the development of early vascular damage.

The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of care processes and outcomes in five most common ACHDi interventions by enabling prospective and retrospective registry-based studies to answer important clinical practice and policy-relevant questions.