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High Risk Trial:
Is sponsored by Children's Hospital Boston.
This trial uses the CardioSEAL and STARFlex devices to close complex heart
defects. For various reasons, some patients are considered to
have a higher surgical risk for device closure, such as those with
complex forms of heart disease, or those with other non-cardiac
medical problems. For these patients, device closure of their
heart defect with either the CardioSEAL or STARFlex device may be
preferable to the conventional surgical approach.
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General Entry Criteria:
- Patient information is submitted to an independent peer-review
team consisting of a cardiologist and cardiac surgeon.
- The peer-review team assesses the medical information and must
agree that the patient has a heart defect that warrants device
closure, and that surgery is either risky or unlikely to be
successful.
- Willingness to comply with device study follow-up visits/testing:
Follow-up Appointments
- 1. Patients need follow-up appointments at the following
time intervals:
- One month - (Timing window 2-6 weeks post implant)
- Six months - (Timing window 4-8 months post implant)
- Twelve months - (Timing window 8-16 months post implant)
- Twenty-four months - (Timing window 18-30 months post implant)
- 2. The patients must return to the implanting center for
their 6 month follow-up appointment. All other testing
may be done at the referring physician's center, but may also
be done at the implanting center if the patient chooses.
Testing Required
- The following tests are required at pre-procedure, pre-discharge,
and all follow-up times listed above. Note: The 6
month followup tests MUST be conducted at
Children's Hospital Boston.
Oxygen
Saturation
Chest x-ray
Echocardiogram
In addition, a Fluoroscopy
must be performed at the 6 or 12 month follow-up, as well as
at the 24 month follow-up.
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Examples of the types of defects closed with the CardioSEAL and STARFlex
devices are:
- Complex muscular ventricular septal defects (single or multiple
defects).
- Patients with "leaks" near one of their heart valves.
- Patent ductus arteriosus
- Complex atrial septal defects
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