Atrial Septal Defect
Conditions
Brief summary
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
Detailed description
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.
Interventions
Percutaneous Atrial Septal Defect Closure
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
All responses must be Yes to be eligible: 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
All responses must be No to be eligible: 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 or disability. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With 6-Month Closure Success | 6 months | Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation. |
| Number of Subjects With 6-Month Composite Clinical Success | 6 months | Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: 1. Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder 2. Safety Success: * Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) through 30 days post-procedure * Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (180 days) post-procedure 3. Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Technical Success | During procedure; median duration 67 minutes | Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder |
| Number of Subjects With Procedure Success | During procedure; median duration 67 minutes | Among subjects with attempted study device closure, the number of subjects with technical success and measured residual defect status of occluded, small, or moderate of the target ASD at conclusion of index procedure |
| Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE | 30 days | Among subjects with attempted study device closure, the number of subjects experiencing one or more device- or procedure-related serious adverse events (SAEs) within 30 days post-index procedure as adjudicated by the Independent Data Review Board (IDRB) |
| Measured Residual Target Defect Size | 6 months | Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation. |
| Number of Subjects With Clinically Significant New Arrhythmia | 6 months | The number of subjects with any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting \> 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.) in subjects without prior history of arrhythmia, as adjudicated by the Independent Data Review Board |
| Number of Subjects With Wire Frame Fracture | 6 months | Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Sommer, MD
Columbia University of New York
PRINCIPAL_INVESTIGATORMatthew Gillespie, MD
Children's Hospital of Philadelphia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure | 125 |
| Total | 125 |
Baseline characteristics
| Characteristic | Device |
|---|---|
| Age, Continuous | 12.3 years |
| Anterior-Superior Aortic Rim Length | 4 mm |
| Atrial Septal Aneurysm | 6 Participants |
| Cardiac Arrhythmia History | 17 Participants |
| Diabetes Mellitus Current | 2 Participants |
| Diabetes Mellitus Previous/Never | 123 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Headaches or Migraines Current | 7 Participants |
| Headaches or Migraines Never | 109 Participants |
| Headaches or Migraines Previous | 9 Participants |
| Height | 148 cm |
| Hypercholesterolemia Current | 8 Participants |
| Hypercholesterolemia Previous/Never | 117 Participants |
| Hypertension Current | 6 Participants |
| Hypertension Previous/Never | 119 Participants |
| Multiple Fenestrations | 18 Participants |
| Nicotene Use >1 year ago | 2 Participants |
| Nicotene Use Never | 122 Participants |
| Nicotene Use Within past year | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 28 Participants |
| Race (NIH/OMB) White | 83 Participants |
| Region of Enrollment United States | 125 participants |
| Septal Length | 39 mm |
| Sex: Female, Male Female | 86 Participants |
| Sex: Female, Male Male | 39 Participants |
| Stop Flow Balloon Defect Size | 17 mm |
| Weight | 41.5 kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 125 |
| other Total, other adverse events | 57 / 125 |
| serious Total, serious adverse events | 8 / 125 |
Outcome results
Primary
Number of Subjects With 6-Month Closure Success
Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.
Time frame: 6 months
Population: Pivotal subjects with technical success and 6-month clinical residual defect status evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Subjects With 6-Month Closure Success | 112 Participants |
Comparison: Test null hypothesis of equal or lesser proportion with 6-month closure success compared to a performance goal (PG).~H0: P ≤ 0.88 vs H1: P \> 0.88, where P is the true proportion of subjects with 6-month closure success and 0.88 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=103 subjects provide ≥95% power to exclude PG with 95% confidence if P=0.98 under H1.p-value: <0.0001Binomial test (exact)
Primary
Number of Subjects With 6-Month Composite Clinical Success
Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: 1. Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder 2. Safety Success: * Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) through 30 days post-procedure * Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (180 days) post-procedure 3. Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation
Time frame: 6 months
Population: All enrolled pivotal subjects with 6-month clinical success evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Subjects With 6-Month Composite Clinical Success | 108 Participants |
Comparison: Test null hypothesis of equal or lesser proportion with 6-month clinical success compared to a performance goal (PG).~H0: P ≤ 0.76 vs H1: P \> 0.76, where P is the true proportion of subjects with 6-month clinical success and 0.76 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=112 subjects provide 95% power to exclude PG with 95% confidence if P=0.88 under H1.p-value: <0.0001Binomial test (exact)
Secondary
Measured Residual Target Defect Size
Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.
Time frame: 6 months
Population: Pivotal subjects with technical success and 6-month measured residual defect status evaluation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Device | Measured Residual Target Defect Size | 0.0 mm |
Secondary
Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE
Among subjects with attempted study device closure, the number of subjects experiencing one or more device- or procedure-related serious adverse events (SAEs) within 30 days post-index procedure as adjudicated by the Independent Data Review Board (IDRB)
Time frame: 30 days
Population: All enrolled pivotal subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE | 6 Participants |
Secondary
Number of Subjects With Clinically Significant New Arrhythmia
The number of subjects with any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting \> 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.) in subjects without prior history of arrhythmia, as adjudicated by the Independent Data Review Board
Time frame: 6 months
Population: All pivotal subjects enrolled -- prior history of arrhythmia reported on the medical history form does not preclude assessment for, and finding of, clinically significant new arrhythmia from adjudication by the Independent Data Review Board
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Subjects With Clinically Significant New Arrhythmia | 6 Participants |
Secondary
Number of Subjects With Procedure Success
Among subjects with attempted study device closure, the number of subjects with technical success and measured residual defect status of occluded, small, or moderate of the target ASD at conclusion of index procedure
Time frame: During procedure; median duration 67 minutes
Population: All pivotal subjects enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Subjects With Procedure Success | 120 Participants |
Secondary
Number of Subjects With Technical Success
Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder
Time frame: During procedure; median duration 67 minutes
Population: All pivotal subjects enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Subjects With Technical Success | 120 Participants |
Secondary
Number of Subjects With Wire Frame Fracture
Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation.
Time frame: 6 months
Population: Pivotal subjects with technical success and 6-month fluoroscopy evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Subjects With Wire Frame Fracture | 37 Participants |