The GORE Assured Clinical Study

Principal Investigator: Robert Gray
Keywords: Device , Transcatheter , defects Department: Pediatric Cardiology
IRB Number: 00097866 Co Investigator:  
Specialty: Cardiology, Cardiology
Sub Specialties: Interventional Cardiology, Echocardiography
Recruitment Status: Recruiting

Contact Information

Judy Carle
judy.carle@hsc.utah.edu
801-585-9375

Brief Summary

Primary Objective
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs).

This is a prospective, multicenter, single-arm clinical study comparing outcomes with the GORE® CARDIOFORM ASD Occluder to performance goals derived from clinical investigation outcomes for devices indicated for ASD closure.

 

Inclusion Criteria

Inclusion Criteria:

1. Patient has an ostium secundum ASD with evidence of left-to-right shunt and right
ventricular volume overload.

2. Patient has a defect size 8-35 mm as measured directly by stop-flow balloon sizing.

3. Patient vasculature can accommodate the delivery system and procedural
accessories.

4. Patient can accommodate TEE or intracardiac echocardiography (ICE) probe for
implant procedure.

5. Patient is judged by the implanting physician to have adequate septal rims to retain
the study device.

6. Patient (or legal guardian, if patient is a minor) will voluntarily sign a Patient Informed
Consent Form (ICF) specific to the study. The Patient ICF must be reviewed and
approved in a manner that complies with requirements of the hospital’s Institutional
Review Board (IRB).

7. Patient (and legal guardian, if patient is a minor) is physically and mentally willing to
comply with all study follow-up requirements through 36 months, including routinely
scheduled diagnostic testing and physical examinations.

Exclusion Criteria

Exclusion Criteria:

1.Patient has significant known pre-existing electrophysiologic or structural
cardiovascular defect, or other comorbidities that could elevate morbidity or mortality
beyond what is common for ASD or would require surgical treatment within three (3)
years of device placement. Examples include, but are not limited to, large ventricular
septal defect, hypoplastic left heart syndrome, coarctation, univentricular heart or
tricuspid atresia, pulmonary hypertension, coronary artery disease, valvular or
myocardial dysfunction, and other congenital heart disease requiring surgical repair.

2. Patient has systemic or inherited conditions that would significantly increase risk of
major morbidity and mortality during the term of the study. Examples include
endocarditis, cancer, degenerative neuromuscular disorder, cardiomyopathy, and any
condition expected to result in significant deterioration of health within three (3) years
of the index procedure.

3. Patient has anatomy where the size or position of the occluder would interfere with
other intracardiac or intravasculature structures, such as cardiac valves or pulmonary
veins.

4. Patient has active endocarditis, other infections producing bacteremia, or has known
sepsis within one month of planned implantation, or any other infection that cannot be
treated successfully prior to device placement.

5. Patient has known intracardiac thrombi.

6. Patient has an uncontrolled arrhythmia with evidence of arrhythmia control failure
within the past 90 days (e.g., supraventricular tachycardia while under rate control or
atrial fibrillation while under rhythm control) or requires electrophysiology study or
concomitant intervention with device placement.

7. Patient is awaiting a procedure that requires trans-septal left atrial access within 6
months of implant procedure.

8. Patient has a history of stroke resulting in a significant morbidity.

9. Patient is pregnant or lactating at time of screening.

10. Patient has contraindication to antiplatelet and anticoagulant medications.

11. Patient has elevated pulmonary vascular resistance (PVR) which in the opinion of the
implanting physician precludes safe defect closure.

12. Patient has multiple defects based on screening imaging and stop-flow balloon sizing
that would require placement of more than one device.