Septal Defect, Atrial
Conditions
Brief summary
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.
Detailed description
Ostium secundum atrial septal defects present as a persistent communication between the atria and are a common congenital cardiac anomaly accounting for approximately 10% of all congenital heart disease. They are one of the most common congenital heart defects to present in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure, pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated that approximately 10,000 new patients per year can be expected to have an ASD. Successful surgical repair of ASD has been performed for 50 years with continued improvement in technique and outcomes. King and Mills reported the first transcatheter closure of ASD in 1976, but the delivery system was quite large and impractical, especially for younger patients. With time, improvements in design concepts and materials discoveries have led to improved results in transcatheter closure systems. Several devices are now available commercially for transcatheter 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
* ASD less than or equal to 17 mm.
Exclusion criteria
* Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events. * Unable to accommodate device delivery catheter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Septal Occluder 2. Safety Success: * Freedom from any Serious Adverse Event (SAE) 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 (195 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 Procedure Success | During procedure; median duration 68 minutes | Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure. |
| Number of Subjects With 30-day SAE | 30 days | Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure |
| Number of Subjects With Technical Success | During procedure; median duration 68 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 Septal Occluder |
| Number of Subjects With 12-Month Closure Success | 12 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 12-month evaluation. |
| Number of Subjects With 36-Month Closure Success | 36 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 36-month evaluation. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Device ASD closure with the GORE® CARDIOFORM Septal Occluder | 400 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 36-Month Closure Evaluation | Missed Echocardiograph | 62 |
| 36-Month Closure Evaluation | Test Device Removal | 2 |
| 6-Month Clinical Success Evaluation | Missed Echocardiograph | 32 |
| 6-Month Closure Evaluation | Technical Failure (No Test Device) | 26 |
Baseline characteristics
| Characteristic | Test Device |
|---|---|
| Age, Continuous | 6.9 years |
| Anterior-Superior Aortic Rim Length | 5.0 mm |
| Atrial Septal Aneurysm | 31 Participants |
| Cardiac Arrhythmia History Current | 13 Participants |
| Cardiac Arrhythmia History Previous/Never | 387 Participants |
| Cigarette Smoking Current | 7 Participants |
| Cigarette Smoking Never | 385 Participants |
| Cigarette Smoking Previous | 8 Participants |
| Diabetes Mellitus Current | 13 Participants |
| Diabetes Mellitus Previous/Never | 387 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 319 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 26 Participants |
| Headaches Current | 15 Participants |
| Headaches Previous/Never | 385 Participants |
| Height | 122.0 cm |
| Hypertension Current | 18 Participants |
| Hypertension Previous/Never | 382 Participants |
| Migraines Current | 15 Participants |
| Migraines Previous/Never | 385 Participants |
| Multiple Fenestrations | 94 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 16 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 45 Participants |
| Race (NIH/OMB) White | 286 Participants |
| Region of Enrollment United States | 400 participants |
| Septal Length | 34.0 mm |
| Sex: Female, Male Female | 234 Participants |
| Sex: Female, Male Male | 166 Participants |
| Stop Flow Balloon Defect Size | 12.0 mm |
| Weight | 25.0 kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 400 |
| other Total, other adverse events | 260 / 400 |
| serious Total, serious adverse events | 28 / 400 |
Outcome results
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 Septal Occluder 2. Safety Success: * Freedom from any Serious Adverse Event (SAE) 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 (195 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 subjects with 6-month clinical success evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Device | Number of Subjects With 6-Month Composite Clinical Success | 332 Participants |
Comparison: Test null hypothesis of inferiority of test device (test) compared to historical device (control).~H0: Pc - Pt ≥ Δ vs H1: Pc - Pt \< Δ, where Pt and Pc are true proportions of 6-month clinical success for test and control, respectively, and Δ is the non-inferiority margin.~Given Nc = 253, then Nt = 135 test subjects provides 86% power to reject H0 with 95% confidence if Δ = 0.10 and Pc = Pt = 0.866 under H0.p-value: <0.00012-sample binomial proportions test
Secondary
Number of Subjects With 12-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 12-month evaluation.
Time frame: 12 months
Population: Enrolled subjects with technical success and 12-month clinical residual defect status evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Device | Number of Subjects With 12-Month Closure Success | 337 Participants |
Secondary
Number of Subjects With 30-day SAE
Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Device | Number of Subjects With 30-day SAE | 7 Participants |
Secondary
Number of Subjects With 36-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 36-month evaluation.
Time frame: 36 months
Population: Enrolled subjects with technical success and 36-month clinical residual defect status evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Device | Number of Subjects With 36-Month Closure Success | 277 Participants |
Secondary
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: Enrolled subjects with technical success and 6-month clinical residual defect status evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Device | Number of Subjects With 6-Month Closure Success | 338 Participants |
Secondary
Number of Subjects With Procedure Success
Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure.
Time frame: During procedure; median duration 68 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Device | Number of Subjects With Procedure Success | 364 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 Septal Occluder
Time frame: During procedure; median duration 68 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Device | Number of Subjects With Technical Success | 374 Participants |