Clinical Trial Fact Sheet / Eligibility

What is the RESPECT Trial?
The RESPECT Trial is a clinical study that will help determine whether a common genetic heart defect, patent foramen ovale (PFO), contributes to cryptogenic stroke, which is a stroke with no known cause. A PFO is a small hole between the upper chambers of the heart. Nearly a quarter of people have a PFO, but most don't know because they don't feel any symptoms.¹

AGA Medical LLC, is conducting the RESPECT Trial among cryptogenic stroke survivors who have PFOs. Working with neurologists, cardiologists and other physicians, AGA Medical is recruiting these patients at various trial sites across the country.

The study will help establish the effectiveness of the company's AMPLATZER^® PFO Occluder, which can be implanted in a patient's heart to close a PFO versus standard medical management (taking medicine).

How is the RESPECT Trial conducted?
Participants are randomly assigned to one of two groups. One group will receive the AMPLATZER^® PFO Occluder. The other group will not receive the device, and instead will follow the current standard of care: receiving blood-thinning medicine to potentially decrease the risk of another stroke. A physician will decide which type and amount of medicine is the best treatment plan for each participant that is randomized to receive medicine. Participants will then have regularly scheduled appointments with their study physician throughout the duration of the study. At the conclusion of the study, results will be analyzed and then compared between groups to determine which was most effective in the possible prevention of recurrent cryptogenic strokes.

Who can participate?
To be considered for participation in the RESPECT Trial, participants must meet the following criteria:

• Be 18 to 60 years of age
• Have been diagnosed with a cryptogenic stroke in the last 270 days
• Be tested to confirmed having a PFO

How long will the study last?
The RESPECT Trial began in 2003 and may last for a duration of 8 years. The study requires follow-up visits at one month, six months, 12 months, 18 months, 24 months and annually thereafter until the study is completed.

How do I enroll in the RESPECT Trial?
Contact a participating physician. For a list of cardiologists and neurologists involved in the RESPECT Trial, go to the physician locator.

Patients will be given further details on the study from the physician. Prior to enrollment, patient will sign an informed consent document, which will provide details on the study treatment and what to expect.

¹ Hagen, P. et al: Incidence and Size of Patent Foramen Ovale During the First
   10 Decades of Life: An Autopsy Study of 965 Normal Hearts. Mayo Clinic
   Proc. 59, 1984