Patients are referred to a Children's
Hospital Boston cardiologist by their doctor. Information is
sent to help with the study entry process.
The Children's Hospital Boston
cardiologist reviews the information to be certain that he/she agrees
that device placement is a good alternative and that the patient is a
candidate for device placement.
The patient and family are informed about the device and study
procedures by the research nurses or one of the research assistants.
The procedure (cardiac catheterization with probable device placement)
is generally scheduled for the following day.
Occasionally, High Risk Trial patients are admitted to the hospital the night prior to the procedure.
Most patients arrive at the hospital the morning of the procedure.
.
After Device Placement:
Patients are admitted to the cardiac service after device placement.
Patients are generally discharged the day after the procedure.
Follow-up appointments necessary for this device study are discussed and
scheduled prior to discharge.
If No Device Placed:
Not all patients who undergo the procedure will receive a device.
If at the time of the procedure the implanting cardiologist does not feel
that the defect warrants a device, no device will be implanted.
If you do not receive a device, you do not need to return for
follow-up visits for the device study.
