Trial Outcomes & Findings for Long-term Safety Study of the GORE® HELEX® Septal Occluder (NCT NCT00581308)
NCT ID: NCT00581308
Last Updated: 2018-02-19
Results Overview
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
COMPLETED
NA
215 participants
12 months
2018-02-19
Participant Flow
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.
Only subjects with a successful implant of the device were included from each study.
Participant milestones
| Measure |
PAS Subjects
Subjects with occluder in place upon leaving cath lab
|
|---|---|
|
Pre Discharge
STARTED
|
215
|
|
Pre Discharge
COMPLETED
|
213
|
|
Pre Discharge
NOT COMPLETED
|
2
|
|
Month 1
STARTED
|
213
|
|
Month 1
COMPLETED
|
205
|
|
Month 1
NOT COMPLETED
|
8
|
|
Month 6
STARTED
|
205
|
|
Month 6
COMPLETED
|
202
|
|
Month 6
NOT COMPLETED
|
3
|
|
Month 12
STARTED
|
202
|
|
Month 12
COMPLETED
|
182
|
|
Month 12
NOT COMPLETED
|
20
|
|
24 Months
STARTED
|
182
|
|
24 Months
COMPLETED
|
176
|
|
24 Months
NOT COMPLETED
|
6
|
|
36 Months
STARTED
|
176
|
|
36 Months
COMPLETED
|
170
|
|
36 Months
NOT COMPLETED
|
6
|
|
48 Months
STARTED
|
170
|
|
48 Months
COMPLETED
|
161
|
|
48 Months
NOT COMPLETED
|
9
|
|
60 Months
STARTED
|
161
|
|
60 Months
COMPLETED
|
158
|
|
60 Months
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
PAS Subjects
Subjects with occluder in place upon leaving cath lab
|
|---|---|
|
Pre Discharge
Lost to Follow-up
|
1
|
|
Pre Discharge
Device Removed
|
1
|
|
Month 1
Lost to Follow-up
|
3
|
|
Month 1
Withdrawal by Subject
|
2
|
|
Month 1
Device Removed
|
2
|
|
Month 1
Uknown
|
1
|
|
Month 6
Lost to Follow-up
|
1
|
|
Month 6
Withdrawal by Subject
|
2
|
|
Month 12
Death
|
1
|
|
Month 12
Lost to Follow-up
|
14
|
|
Month 12
Withdrawal by Subject
|
3
|
|
Month 12
Device Removed
|
1
|
|
Month 12
Other
|
1
|
Baseline Characteristics
Long-term Safety Study of the GORE® HELEX® Septal Occluder
Baseline characteristics by cohort
| Measure |
PAS Subjects
n=215 Participants
Subjects with occluder in place upon leaving cath lab
|
|---|---|
|
Age, Categorical
<=18 years
|
188 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
Mean (Standard Deviation)
|
11.3 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Age, Customized
|
6.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
141 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
6 participants
n=5 Participants
|
|
Defect Size by Direct Balloon Sizing
With Value
|
209 Participants
n=5 Participants
|
|
Defect Size by Direct Balloon Sizing
Missing Value
|
6 Participants
n=5 Participants
|
|
Defect Size by Direct Balloon Sizing
|
13 (mm)
n=5 Participants
|
|
Multiple Fenestrations Noted
Yes
|
39 Participants
n=5 Participants
|
|
Multiple Fenestrations Noted
No
|
176 Participants
n=5 Participants
|
|
General Medical History: Previous Cardiac Surgery
Yes
|
12 Participants
n=5 Participants
|
|
General Medical History: Previous Cardiac Surgery
No
|
203 Participants
n=5 Participants
|
|
General Medical History: ECG Abnormalities
Yes
|
97 Participants
n=5 Participants
|
|
General Medical History: ECG Abnormalities
No
|
118 Participants
n=5 Participants
|
|
General Medical History: Cardiac Arrhythmia(s)
Yes
|
16 Participants
n=5 Participants
|
|
General Medical History: Cardiac Arrhythmia(s)
No
|
199 Participants
n=5 Participants
|
|
General Medical History: Other (non-ASD) Cardiac Disease
Yes
|
28 Participants
n=5 Participants
|
|
General Medical History: Other (non-ASD) Cardiac Disease
No
|
187 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Subjects with Successful Device Delivery
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
Outcome measures
| Measure |
Clinical Success at 12 Months
n=210 Participants
Subjects with occluder in place upon leaving cath lab
|
|---|---|
|
Efficacy
Subjects Evaluated
|
180 Participants
|
|
Efficacy
Clinical Success
|
171 Participants
|
|
Efficacy
Clinical Failure
|
9 Participants
|
|
Efficacy
Major Device/Procedure Adverse Event
|
8 Participants
|
|
Efficacy
Significant Leak on Core Lab Evaluation
|
1 Participants
|
|
Efficacy
Subjects Not Evaluated
|
30 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Subjects with Successful Device Delivery
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
Outcome measures
| Measure |
Clinical Success at 12 Months
n=133 Participants
Subjects with occluder in place upon leaving cath lab
|
|---|---|
|
Efficacy
Subjects Evaluated
|
133 Participants
|
|
Efficacy
Clinical Success
|
123 Participants
|
|
Efficacy
Clinical Failure
|
10 Participants
|
|
Efficacy
Major Device/Procedure Adverse Event
|
9 Participants
|
|
Efficacy
Significant Leak on Core Lab Evaluation
|
1 Participants
|
|
Efficacy
Subjects Not Evaluated
|
77 Participants
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: Subjects with Successful Device Delivery
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
Outcome measures
| Measure |
Clinical Success at 12 Months
n=152 Participants
Subjects with occluder in place upon leaving cath lab
|
|---|---|
|
Efficacy
Subjects Evaluated
|
152 Participants
|
|
Efficacy
Clinical Success
|
143 Participants
|
|
Efficacy
Clinical Failure
|
9 Participants
|
|
Efficacy
Major Device/Procedure Adverse Event
|
9 Participants
|
|
Efficacy
Significant Leak on Core Lab Evaluation
|
0 Participants
|
|
Efficacy
Subjects Not Evaluated
|
58 Participants
|
PRIMARY outcome
Timeframe: 5 yearsA 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.
Outcome measures
| Measure |
Clinical Success at 12 Months
n=215 Participants
Subjects with occluder in place upon leaving cath lab
|
|---|---|
|
Safety
|
10 Participants
|
Adverse Events
PAS Subjects
Serious adverse events
| Measure |
PAS Subjects
n=215 participants at risk
Subjects with occluder in place upon leaving cath lab
|
|---|---|
|
Cardiac disorders
Cardiac Overall
|
2.3%
5/215 • Number of events 7 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Cardiac disorders
Arrhythmia
|
0.93%
2/215 • Number of events 4 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Cardiac disorders
Embolization (post-procedure)
|
0.93%
2/215 • Number of events 2 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Cardiac disorders
Valvular Damage
|
0.47%
1/215 • Number of events 1 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Investigations
Device (HELEX Septal Occluder) Overall
|
1.9%
4/215 • Number of events 4 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Investigations
Device removal due to fracture
|
1.4%
3/215 • Number of events 3 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Investigations
Device removal-other
|
0.47%
1/215 • Number of events 1 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Nervous system disorders
Neurologic Overall
|
0.47%
1/215 • Number of events 2 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Nervous system disorders
Headache
|
0.47%
1/215 • Number of events 1 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Nervous system disorders
Other - Neurologic complication
|
0.47%
1/215 • Number of events 1 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
Other adverse events
| Measure |
PAS Subjects
n=215 participants at risk
Subjects with occluder in place upon leaving cath lab
|
|---|---|
|
Nervous system disorders
Headache (Minor)
|
10.2%
22/215 • Number of events 26 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Cardiac disorders
Arrhythmia (Minor)
|
5.1%
11/215 • Number of events 12 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Cardiac disorders
Palipations (Minor)
|
3.3%
7/215 • Number of events 9 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
|
Investigations
Fracture-wire frame (Minor)
|
8.8%
19/215 • Number of events 19 • Through 5 years post-procedure
Major Adverse Events from Procedure through 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER