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The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
The GORE® HELEX® Septal Occluder is an approved medical device indicated for the transcatheter closure of atrial septal defects (ASDs). The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs). This is an FDA Condition of Approval Study. All subjects enrolled in this study will be followed for long-term safety and efficacy of the occluder device through 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE® HELEX® Septal Occluder | Experimental | Subjects who received a GORE® HELEX® Septal Occluder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® HELEX® Septal Occluder | Device | Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:
| 12 months |
| Efficacy | A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:
| 36 months |
| Efficacy | A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:
| 60 months |
| Safety | A calculation of the proportion of subjects experiencing one or more major device or procedure related adverse event(s) at 1, 2, 3, 4, and 5 years post procedure. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry A Latson, MD | Joe DiMaggio Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
Only subjects with a successful implant of the device were included from each study.
Data was combined from the following sources: (1) Continued Access Study of the GORE® HELEX® Septal Occluder (PMA Subjects HLX 03-01 - last 87 non-training subjects) and (2) subjects implanted with the HELEX device enrolled in the Post-Approval Study of the GORE® HELEX® Septal Occluder (n=128). The total number of subjects enrolled is 215.
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| ID | Title | Description |
|---|---|---|
| FG000 | PAS Subjects | Subjects with occluder in place upon leaving cath lab |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre Discharge |
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| Month 1 |
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| Month 6 |
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| Month 12 |
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| 24 Months |
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| 36 Months |
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| 48 Months |
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| 60 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | PAS Subjects | Subjects with occluder in place upon leaving cath lab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy | A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:
| Subjects with Successful Device Delivery | Posted | Number | Participants | 12 months |
|
Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PAS Subjects | Subjects with occluder in place upon leaving cath lab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Overall | Cardiac disorders | Internal System | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache (Minor) | Nervous system disorders | Internal System | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay Donosky | W. L. Gore & Associates | (800) 437-8181 | jdonosky@wlgore.com |
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| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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|
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Customized | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Defect Size by Direct Balloon Sizing | Number | Participants |
|
| Defect Size by Direct Balloon Sizing | Mean | Standard Deviation | (mm) |
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| Defect Size by Direct Balloon Sizing | Median | Full Range | (mm) |
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| Multiple Fenestrations Noted | Number | Participants |
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| General Medical History: Previous Cardiac Surgery | Number | Participants |
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| General Medical History: ECG Abnormalities | Number | Participants |
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| General Medical History: Cardiac Arrhythmia(s) | Number | Participants |
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| General Medical History: Other (non-ASD) Cardiac Disease | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Efficacy | A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:
| Subjects with Successful Device Delivery | Posted | Number | Participants | 36 months |
|
|
|
| Primary | Efficacy | A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:
| Subjects with Successful Device Delivery | Posted | Number | Participants | 60 months |
|
|
|
| Primary | Safety | A calculation of the proportion of subjects experiencing one or more major device or procedure related adverse event(s) at 1, 2, 3, 4, and 5 years post procedure. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 9 |
| 215 |
| 54 |
| 215 |
| Arrhythmia | Cardiac disorders | Internal System | Systematic Assessment |
|
| Embolization (post-procedure) | Cardiac disorders | Internal System | Systematic Assessment |
|
| Valvular Damage | Cardiac disorders | Internal System | Systematic Assessment |
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| Device (HELEX Septal Occluder) Overall | Investigations | Internal System | Systematic Assessment |
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| Device removal due to fracture | Investigations | Internal System | Systematic Assessment |
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| Device removal-other | Investigations | Internal System | Systematic Assessment |
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| Neurologic Overall | Nervous system disorders | Internal System | Systematic Assessment |
|
| Headache | Nervous system disorders | Internal System | Systematic Assessment |
|
| Other - Neurologic complication | Nervous system disorders | Internal System | Systematic Assessment |
|
| Arrhythmia (Minor) | Cardiac disorders | Internal System | Systematic Assessment |
|
| Palipations (Minor) | Cardiac disorders | Internal System | Systematic Assessment |
|
| Fracture-wire frame (Minor) | Investigations | Internal System | Systematic Assessment |
|
Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|---|
|
| Major Device/Procedure Adverse Event |
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| Significant Leak on Core Lab Evaluation |
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| Subjects Not Evaluated |
|
| Title | Measurements |
|---|---|
|
| Major Device/Procedure Adverse Event |
|
| Significant Leak on Core Lab Evaluation |
|
| Subjects Not Evaluated |
|