Common Patient Questions

Do I qualify for the RESPECT study?
Participants must be 18 to 60 years old, have had a cryptogenic stroke and been diagnosed with a patent foramen ovale (PFO), a small hole in the heart. Patients need to be enrolled within 270 days of their last stroke.

How do I enroll in the study?
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.

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.

What happens during the procedure?
The procedure is minimally invasive. A doctor implants the AMPLATZER PFO Occluder using a catheter a sterile, flexible, hollow tube that is inserted in the patient's groin and navigated through large veins or arteries to the heart. The device consists of two wire-mesh discs, filled with polyester fabric, that closes a PFO. The procedure lasts about one to two hours. Most patients leave the hospital within 24 hours.

How long will I need to participate in the study?
Participation in the RESPECT Trial is expected to last two to eight 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.

Can I choose the hospital or clinic I go to?
For a list of sites involved in the RESPECT Trial, go to the physician locator. You may contact the site directly for information about participation.