ASD Trial

CardioSEAL & STARFlex Logo

ASD TRIAL

ASD Trial: The ASD Trial is sponsored by Nitinol Medical Technologies, Inc., , the manufacturer of the device. The trial uses the STARFlex device to close Atrial Septal Defects. The original ASD Trial was started in 1997 and used the CardioSEAL device. 151 patients underwent device implantation at more than 10 hospitals in the United States. At that point, the study stopped enrolling patients for devices until it received FDA approval for the STARFlex device. The study will now implant 151 patients with the STARFlex device, and then compare the information to a group of patients who had undergone surgical closure for their ASD.

General Entry Criteria for Patients with Atrial Septal Defects

Secundum Atrial Septal Defect (ASD).

Free of other cardiac defects or significant illness.

Over two years of age.

Defect less than or equal to stretch diameter of 22 mm measured by Transesophageal Echocardiogram during catheterization.

Willingness to comply with device study follow-up visits/testing. Please contact us for more information.

Follow-up Requirements for Patients Who Receive a Device. NOTE: All Follow-up testing is done at Children's Hospital Boston.

At one month:

Physical examination
EKG
Chest X-ray OR Fluoroscopic evaluation of device

At six months:

Physical examination
EKG
Echocardiogram
Fluoroscopic evaluation

At twelve months:

Physical examination
EKG
Echocardiogram
Chest X-ray OR Fluoroscopic evaluation of device

At twenty-four months:

Patients will be enrolled in a registry through NMT, Inc. and contacted at 24 months post implant.
Tests may include those performed at the 12 month follow-up.