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Patent Foramen Ovale clinical trials

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NCT ID: NCT01333761 Terminated - Clinical trials for Patent Foramen Ovale

Cardiox Shunt Detection Technology Study

Start date: April 2011
Phase: Phase 3
Study type: Interventional

The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against transesophageal echocardiography (TEE) for sensitivity and specificity, as well as transcranial doppler (TCD) for positive percent agreement and negative percent agreement.

NCT ID: NCT01257880 Completed - Migraine With Aura Clinical Trials

Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP)

CAMP
Start date: January 2010
Phase: N/A
Study type: Observational

The purpose of the study is to compare the rate of comorbidities associated with migraine aura (MA) between persons who have a large circulatory right-to-left shunt (RLS) and those who do not have RLS. Approximately 50% of individuals who have MA also have RLS due to patent foramen ovale (PFO). A PFO is an anatomical opening or flap between the upper chambers of the heart or atria that permits blood to pass from the right of the heart to the left side of the heart, without first going to the lungs to be filtered and oxygenated. Many health conditions and clinical syndromes including stroke, sleep apnea, and migraine have been linked to PFO. Although the mechanism is undetermined, it is hypothesized that microscopic blood clots and chemicals such as serotonin can pass through the PFO, travel to the brain, and cause headache and aura. Persons who have MA are at increased risk for stroke and transient ischemic attacks relative to people who do not have migraine. Migraine is also associated with the presence of white matter lesions in the brain and mild deficits in cognitive function associated with the posterior brain (vision, memory, processing speed). The risk of stroke in migraine is highest for women under the age of 45 who have aura and a high number of migraine headache days per month. No convincing evidence has been produced to explain the mechanism for the increased risk of ischemic stroke in migraine; however, increased platelet activation and aggregation is a plausible theory. We hypothesize that migraineurs with aura and large RLS (presumably due to a PFO) will be more likely to have sleep apnea, increased platelet activation, cognitive deficits, alterations in cerebral vasomotor function, and white matter lesions than migraineurs with aura who do not have PFO. The results of this exploratory study will generate hypotheses as to why subgroups of migraineurs have an increased risk of stroke and the impact of large PFO on comorbid conditions associated with migraine aura. Early identification of migraine subgroups with a constellation of clinical syndromes that increase risk of neurovascular diseases will allow initiation of preventive strategies that may ultimately reduce burden and improve the productive quality of life for these individuals.

NCT ID: NCT01216423 Completed - Pulmonary Embolism Clinical Trials

Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale

EPIC-FOP
Start date: November 2009
Phase: N/A
Study type: Observational

The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism.

NCT ID: NCT01068366 Terminated - Clinical trials for Patent Foramen Ovale

Nickel Allergy With Septal Closure Devices

NASAH
Start date: February 2010
Phase: N/A
Study type: Observational

This study is for patients who have been diagnosed with either a Patent Foramen Ovale [PFO] or an Atrial Septal Defect [ASD]. These are a type of hole located in the wall that separates the top two (2) chambers of the heart. You have been recommended to receive an atrial septal occluder device [a device specifically designed to close PFOs and ASDs] implanted in your heart to close this hole. Because these devices are made of materials that contain nickel, this trial is being conducted to perform blood nickel tests on those patients already referred for an atrial septal occluder device such as yourself. The purpose of this study is to compare levels of nickel in the blood in patients receiving either the Amplatzer or the Helex devices.

NCT ID: NCT01018355 Terminated - Stroke Clinical Trials

The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI

CryptoCard
Start date: October 2009
Phase: N/A
Study type: Interventional

The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical management alone in elderly patients above 50 years of age with a PFO and a history of cryptogenic stroke or TIA.

NCT ID: NCT00831259 Completed - Pulmonary Embolism Clinical Trials

Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)

ICEP
Start date: October 2007
Phase: N/A
Study type: Observational

Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. We will assess the rate of clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE) in relation to the presence or not of a PFO.

NCT ID: NCT00697151 Completed - Ischemic Stroke Clinical Trials

Patent Foramen Ovale in Cryptogenic Stroke Study

PICSS
Start date: June 1993
Phase: Phase 4
Study type: Interventional

The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.

NCT ID: NCT00584064 Approved for marketing - Clinical trials for Patent Foramen Ovale

Emergency/Compassionate Use PFO Occluder

Start date: n/a
Phase:
Study type: Expanded Access

Emergency/compassionate use for the AMPLATZER PFO Occluder

NCT ID: NCT00583401 No longer available - Stroke Clinical Trials

PFO ACCESS Registry

Start date: n/a
Phase:
Study type: Expanded Access

Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.

NCT ID: NCT00562289 Completed - Ischemic Stroke Clinical Trials

Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence

CLOSE
Start date: December 2007
Phase: Phase 3
Study type: Interventional

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.