Septal Defect, Atrial
Conditions
Keywords
atrial septal defect, septal occluder, HELEX
Brief summary
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).
Detailed description
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.
Interventions
DEVICEGORE® HELEX® Septal Occluder
Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* ASD less than or equal to 18 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 |
|---|---|---|
| Efficacy | 12 months | 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: * Any major device/procedure adverse event * Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group. * Clinically significant leak at the follow-up visit |
| Safety | 5 years | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Only subjects with a successful implant of the device were included from each study.
Participants by arm
| Arm | Count |
|---|---|
| PAS Subjects Subjects with occluder in place upon leaving cath lab | 215 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Month 1 | Device Removed | 2 |
| Month 1 | Lost to Follow-up | 3 |
| Month 1 | Uknown | 1 |
| Month 1 | Withdrawal by Subject | 2 |
| Month 12 | Death | 1 |
| Month 12 | Device Removed | 1 |
| Month 12 | Lost to Follow-up | 14 |
| Month 12 | Other | 1 |
| Month 12 | Withdrawal by Subject | 3 |
| Month 6 | Lost to Follow-up | 1 |
| Month 6 | Withdrawal by Subject | 2 |
| Pre Discharge | Device Removed | 1 |
| Pre Discharge | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | PAS Subjects |
|---|---|
| Age, Categorical <=18 years | 188 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous Mean (Standard Deviation) | 11.3 years STANDARD_DEVIATION 12.9 |
| Age, Customized | 6.5 years |
| Defect Size by Direct Balloon Sizing Missing Value | 6 Participants |
| Defect Size by Direct Balloon Sizing With Value | 209 Participants |
| Defect Size by Direct Balloon Sizing | 12 (mm) STANDARD_DEVIATION 3 |
| General Medical History: Cardiac Arrhythmia(s) No | 199 Participants |
| General Medical History: Cardiac Arrhythmia(s) Yes | 16 Participants |
| General Medical History: ECG Abnormalities No | 118 Participants |
| General Medical History: ECG Abnormalities Yes | 97 Participants |
| General Medical History: Other (non-ASD) Cardiac Disease No | 187 Participants |
| General Medical History: Other (non-ASD) Cardiac Disease Yes | 28 Participants |
| General Medical History: Previous Cardiac Surgery No | 203 Participants |
| General Medical History: Previous Cardiac Surgery Yes | 12 Participants |
| Multiple Fenestrations Noted No | 176 Participants |
| Multiple Fenestrations Noted Yes | 39 Participants |
| Race/Ethnicity, Customized Asian | 8 participants |
| Race/Ethnicity, Customized Black or African American | 23 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 21 participants |
| Race/Ethnicity, Customized Other | 16 participants |
| Race/Ethnicity, Customized Unknown | 6 participants |
| Race/Ethnicity, Customized White or Caucasian | 141 participants |
| Sex: Female, Male Female | 130 Participants |
| Sex: Female, Male Male | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 54 / 215 |
| serious Total, serious adverse events | 9 / 215 |
Outcome results
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: * Any major device/procedure adverse event * Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group. * Clinically significant leak at the follow-up visit
Time frame: 12 months
Population: Subjects with Successful Device Delivery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinical Success at 12 Months | Efficacy | Subjects Evaluated | 180 Participants |
| Clinical Success at 12 Months | Efficacy | Clinical Success | 171 Participants |
| Clinical Success at 12 Months | Efficacy | Clinical Failure | 9 Participants |
| Clinical Success at 12 Months | Efficacy | Major Device/Procedure Adverse Event | 8 Participants |
| Clinical Success at 12 Months | Efficacy | Significant Leak on Core Lab Evaluation | 1 Participants |
| Clinical Success at 12 Months | Efficacy | Subjects Not Evaluated | 30 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: * Any major device/procedure adverse event * Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group. * Clinically significant leak at the follow-up visit
Time frame: 36 months
Population: Subjects with Successful Device Delivery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinical Success at 12 Months | Efficacy | Clinical Failure | 10 Participants |
| Clinical Success at 12 Months | Efficacy | Major Device/Procedure Adverse Event | 9 Participants |
| Clinical Success at 12 Months | Efficacy | Significant Leak on Core Lab Evaluation | 1 Participants |
| Clinical Success at 12 Months | Efficacy | Subjects Evaluated | 133 Participants |
| Clinical Success at 12 Months | Efficacy | Clinical Success | 123 Participants |
| Clinical Success at 12 Months | Efficacy | Subjects Not Evaluated | 77 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: * Any major device/procedure adverse event * Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group. * Clinically significant leak at the follow-up visit
Time frame: 60 months
Population: Subjects with Successful Device Delivery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinical Success at 12 Months | Efficacy | Major Device/Procedure Adverse Event | 9 Participants |
| Clinical Success at 12 Months | Efficacy | Subjects Evaluated | 152 Participants |
| Clinical Success at 12 Months | Efficacy | Clinical Success | 143 Participants |
| Clinical Success at 12 Months | Efficacy | Clinical Failure | 9 Participants |
| Clinical Success at 12 Months | Efficacy | Significant Leak on Core Lab Evaluation | 0 Participants |
| Clinical Success at 12 Months | Efficacy | Subjects Not Evaluated | 58 Participants |
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.
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Success at 12 Months | Safety | 10 Participants |