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Trial record 3 of 12 for:    Atrial Septal Defect 5

Long-term Safety Study of the GORE® HELEX® Septal Occluder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00581308
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : February 7, 2012
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Septal Defect, Atrial
Intervention Device: GORE® HELEX® Septal Occluder
Enrollment 215
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.
Arm/Group Title PAS Subjects
Hide Arm/Group Description Subjects with occluder in place upon leaving cath lab
Period Title: Pre Discharge
Started 215
Completed 213
Not Completed 2
Reason Not Completed
Lost to Follow-up             1
Device Removed             1
Period Title: Month 1
Started 213
Completed 205
Not Completed 8
Reason Not Completed
Lost to Follow-up             3
Withdrawal by Subject             2
Device Removed             2
Uknown             1
Period Title: Month 6
Started 205
Completed 202
Not Completed 3
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             2
Period Title: Month 12
Started 202
Completed 182
Not Completed 20
Reason Not Completed
Death             1
Lost to Follow-up             14
Withdrawal by Subject             3
Device Removed             1
Other             1
Period Title: 24 Months
Started 182
Completed 176
Not Completed 6
Period Title: 36 Months
Started 176
Completed 170
Not Completed 6
Period Title: 48 Months
Started 170
Completed 161
Not Completed 9
Period Title: 60 Months
Started 161
Completed 158
Not Completed 3
Arm/Group Title PAS Subjects
Hide Arm/Group Description Subjects with occluder in place upon leaving cath lab
Overall Number of Baseline Participants 215
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants
<=18 years
188
  87.4%
Between 18 and 65 years
26
  12.1%
>=65 years
1
   0.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean (Standard Deviation) Number Analyzed 215 participants
11.3  (12.9)
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 215 participants
6.5
(0.8 to 88.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants
Female
130
  60.5%
Male
85
  39.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants
White or Caucasian 141
Black or African American 23
Hispanic or Latino 21
Asian 8
Other 16
Unknown 6
Defect Size by Direct Balloon Sizing  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants
With Value 209
Missing Value 6
Defect Size by Direct Balloon Sizing  
Mean (Standard Deviation)
Unit of measure:  (mm)
Number Analyzed 215 participants
12  (3)
Defect Size by Direct Balloon Sizing  
Median (Full Range)
Unit of measure:  (mm)
Number Analyzed 215 participants
13
(5 to 20)
Multiple Fenestrations Noted  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants
Yes 39
No 176
General Medical History: Previous Cardiac Surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants
Yes 12
No 203
General Medical History: ECG Abnormalities  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants
Yes 97
No 118
General Medical History: Cardiac Arrhythmia(s)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants
Yes 16
No 199
General Medical History: Other (non-ASD) Cardiac Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants
Yes 28
No 187
1.Primary Outcome
Title Efficacy
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Successful Device Delivery
Arm/Group Title Clinical Success at 12 Months
Hide Arm/Group Description:
Subjects with occluder in place upon leaving cath lab
Overall Number of Participants Analyzed 210
Measure Type: Number
Unit of Measure: Participants
Subjects Evaluated 180
Clinical Success 171
Clinical Failure 9
Major Device/Procedure Adverse Event 8
Significant Leak on Core Lab Evaluation 1
Subjects Not Evaluated 30
2.Primary Outcome
Title Efficacy
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Successful Device Delivery
Arm/Group Title Clinical Success at 36 Months
Hide Arm/Group Description:
Subjects with occluder in place upon leaving cath lab
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
Subjects Evaluated 133
Clinical Success 123
Clinical Failure 10
Major Device/Procedure Adverse Event 9
Significant Leak on Core Lab Evaluation 1
Subjects Not Evaluated 77
3.Primary Outcome
Title Efficacy
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Successful Device Delivery
Arm/Group Title Clinical Success at 60 Months
Hide Arm/Group Description:
Subjects with occluder in place upon leaving cath lab
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: Participants
Subjects Evaluated 152
Clinical Success 143
Clinical Failure 9
Major Device/Procedure Adverse Event 9
Significant Leak on Core Lab Evaluation 0
Subjects Not Evaluated 58
4.Primary Outcome
Title Safety
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE® HELEX® Septal Occluder
Hide Arm/Group Description:
Subjects who received a GORE® HELEX® Septal Occluder
Overall Number of Participants Analyzed 215
Measure Type: Count of Participants
Unit of Measure: Participants
10
   4.7%
Time Frame Through 5 years post-procedure
Adverse Event Reporting Description Major Adverse Events from Procedure through 5 years
 
Arm/Group Title PAS Subjects
Hide Arm/Group Description Subjects with occluder in place upon leaving cath lab
All-Cause Mortality
PAS Subjects
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PAS Subjects
Affected / at Risk (%) # Events
Total   9/215 (4.19%)    
Cardiac disorders   
Cardiac Overall  1  5/215 (2.33%)  7
Arrhythmia  1  2/215 (0.93%)  4
Embolization (post-procedure)  1  2/215 (0.93%)  2
Valvular Damage  1  1/215 (0.47%)  1
Investigations   
Device (HELEX Septal Occluder) Overall  1  4/215 (1.86%)  4
Device removal due to fracture  1  3/215 (1.40%)  3
Device removal-other  1  1/215 (0.47%)  1
Nervous system disorders   
Neurologic Overall  1  1/215 (0.47%)  2
Headache  1  1/215 (0.47%)  1
Other - Neurologic complication  1  1/215 (0.47%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, Internal System
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
PAS Subjects
Affected / at Risk (%) # Events
Total   54/215 (25.12%)    
Cardiac disorders   
Arrhythmia (Minor)  1  11/215 (5.12%)  12
Palipations (Minor)  1  7/215 (3.26%)  9
Investigations   
Fracture-wire frame (Minor)  1  19/215 (8.84%)  19
Nervous system disorders   
Headache (Minor)  1  22/215 (10.23%)  26
Indicates events were collected by systematic assessment
1
Term from vocabulary, Internal System
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jay Donosky
Organization: W. L. Gore & Associates
Phone: (800) 437-8181
EMail: jdonosky@wlgore.com
Layout table for additonal information
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00581308     History of Changes
Other Study ID Numbers: HLX 06-04
First Submitted: December 20, 2007
First Posted: December 27, 2007
Results First Submitted: January 4, 2012
Results First Posted: February 7, 2012
Last Update Posted: February 16, 2018