Device Patient Registry

CardioSEAL & STARFlex Logo

DEVICE PATIENT REGISTRY

Children's Hospital Boston has created a Registry for all patients who have had a ClamShell I, CardioSEAL or STARFlex device implanted and who have completed all the follow-up visits required by their study. Patients who enroll in the registry agree to allow their physician to continue sending reports of cardiac visits and testing that are performed as part of their regular medical care. The information is logged into a database maintained by the hospital.

The results of this information are used to better understand the long-term performance of these types of cardiac devices and to ensure that no new safety issues have arisen with the devices. It is our hope that the information will be used to help patients and physicians make more informed decisions about their medical care.

If you would like to participate in this Registry, please contact the Device Group. We would be happy to provide you with more information.

Below is a guideline showing what types of cardiac evaluations are recommended by Children's Hospital Boston for patients receiving a device, once they have completed the follow-up visits that are required by their study:

UP TO 5 YEARS AFTER IMPLANTATION:

Every Year:

	Physical Examination
	EKG
	Oxygen saturation
	Chest X-ray
	Echocardiogram

AFTER 5 YEARS:

Every Two Years:

	EKG
	Oxygen Saturation
	Chest X-ray

Every Three to Five Years:

Echocardiogram

As Needed Clinically:

Physical examination