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If you have arrived at my blog after searching for information on PFO,stroke,migraines and/or are researching the connection between the heart and the brain, I’d like to hear from you. Please consider sharing your own story, or if you’d prefer to reach me in private I can be contacted using the form below.

If you’d like to read some of the other stories that have been posted, simply click on the comments link below to read more or post your own story.

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Respect Trial and crypotogenic stroke


Source: http://www.amplatzer.com

also see link at end of article from patient education resources

Respect Trial – United States

AMPLATZER® PFO Occluder – Notice of Availability – Caution: Investigational device. Limited by Federal (U.S.) law to investigational use.

Respect Logo

THE HEART AND STROKE CONNECTION

Evidence indicates there may be a connection between Patent Foramen Ovale (PFO) and cryptogenic stroke. Cryptogenic stroke is a stroke that occurs without the normal symptoms associated with stroke.

Patent Foramen Ovale is one potential suspected cause of cryptogenic stroke. The foramen ovale is a flap or tunnel shaped hole in the atrial septum during fetal development that allows blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. If this opening does not close shortly after birth, a Patent (or open) Foramen Ovale (PFO) results.

It is not known what the best treatment is to reduce the risk of a recurrent stroke. AGA Medical Corporation is conducting the RESPECT Clinical Trial to investigate whether closure of PFO is superior to medical management in preventing recurrent cryptogenic strokes.

Patients 18-60 years of age who have been diagnosed with one cryptogenic stroke and confirmation of a PFO may qualify for the RESPECT Trial. Trial design is a prospective multi-center randomized clinical trial to evaluate safety and efficacy. Closure of the PFO with the AMPLATZER® PFO Occluder, or treatment with the current medical standard of care are used to compare for efficacy and safety.

Links:

Learn more about the RESPECT Trial

Migraine Clinical Trial


I’ve added this information to my blog in response to the many requests I received for individuals searching for more information on the migraine/PFO connection. This information below was snagged directly from the patient education area of the website for the Amplatzer PFO occluder (the device I had implanted in May 07). The link at the bottom of this article will direct you to  their site and the clinical trial.

AMPLATZER® PFO Occluder – Notice of Availability –

Caution: Investigational device. Limited by Federal (U.S.) law to investigational use.

Premium

THE HEART AND MIGRAINE CONNECTION

Patent Foramen Ovale is a defect in the atrial septum, the wall between the two upper chambers of the heart. The foramen ovale is a flap or tunnel shaped hole in the atrial septum during fetal development that allows blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. If this opening does not close shortly after birth, a Patent Foramen Ovale (PFO) results.

Retrospective research has shown that a significant number of people who have had PFO closure for health reasons other than migraines have reported a reduction in frequency, and severity of migraine attacks. For this reason, further knowledge on the relationship between PFO and migraine is being sought. The Premium Trial is designed to evaluate the effectiveness of PFO closure as a treatment for migraine. The trial is a prospective, randomized, sham-controlled, double blind, multi-center study to evaluate safety and efficacy.

To participate, patients must be 18-55 years of age with migraine (with or without aura) reported to have a 3 month history of 6-14 headache days per month and confirmed presence of a PFO. Participants will either have closure of the PFO with the AMPLATZER® PFO Occluder and standard of care medical treatment, or standard of care medical treatment only.

Links:

Learn More About the Premium Migraine Clinical Trial

Heart Anatomy and PFO


source: http://www.amplatzer.com/

Understanding PFO

The heart is divided into four separate chambers. The upper chambers, or atria, are divided by a wall called the atrial septum.

The foramen ovale is a flap or tunnel shaped hole in the atrial septum during fetal development that allows blood to travel through the heart without going to the lungs. When in the womb, a baby does not use his or her own lungs, receiving oxygen rich blood from the the mother through the umbilical cord. Therefore, blood can travel from the right side of the baby’s heart to the left side of the heart through the foramen ovale, skipping the trip to the baby’s lungs.

This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. If this opening does not close shortly after birth, a Patent Foramen Ovale (PFO) results. For people with PFO, some blood from the right atrium can leak into the left atrium. PFO is the most common heart defect. In fact, one in four people may have a PFO to some degree, but in many cases the PFO is not large enough to create symptoms or require any immediate treatment in childhood.

A PFO allows some blood to pass from the right to the left atrium through a tunnel or flap shaped hole in the atrial septum.

Patent Foramen Ovale is categorized as an atrial septal defect, but with a different origin and symptoms than single-hole or multi-fenestrated atrial septal defects. ( learn more about atrial septal defects )

Many people grow up and lead normal lives without even knowing that they have a PFO. PFO is frequently not diagnosed until adulthood. However, there are a number of life-affecting and potentially harmful conditions that may be caused by PFO.

Patent Foramen Ovale is suspected to be a cause of embolic cryptogenic stroke. This type of stroke has no clearly known origin, but blood clotting at or near the PFO is one possible cause. Research is underway to verify this connection between embolic cryptogenic stroke and PFO. Learn more about PFO and stroke research.

In recent years, research into PFO closure has shown that there may be a connection between PFO and migraine headaches. People with migraine headaches who have had PFO closure for other reasons often reported reduction or even cessation of migraine headaches after PFO closure. For this reason, research is underway to determine the effect of PFO closure in reducing or eliminating some forms of migraine.
Learn more about international PFO and migraine research.
Learn more about United States PFO and migraine research.

Treating Patent Foramen Ovale (PFO)

AGA Medical designed the AMPLATZER® PFO Occluder for closure of PFO defects using a minimally-invasive transcatheter procedure instead of surgery.

Source: AGA Mediacl Corporation