Septal Defect, AtrialNCT00581308
Long-term Safety Study of the GORE® HELEX® Septal Occluder
A study testing GORE® HELEX® Septal Occluder in people with Septal Defect, Atrial, run by W.L.Gore & Associates at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Septal Defect, Atrial
- What is being tested?
- GORE® HELEX® Septal Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASD less than or equal to 18 mm.
Who cannot join
- Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events.
- Unable to accommodate device delivery catheter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GORE® HELEX® Septal Occluder Post-Approval Study
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).
Read the 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.
- Conditions
- Septal Defect, Atrial
- Being tested
- GORE® HELEX® Septal Occluder
- Keywords
- atrial septal defect, septal occluder, HELEX
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® HELEX® Septal OccluderDevice
Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)
| Study group | Role | What they receive |
|---|---|---|
| GORE® HELEX® Septal Occluder | Experimental | Subjects who received a GORE® HELEX® Septal Occluder Receives: Device: GORE® HELEX® Septal Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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:
- 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
Measured: 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:
- 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
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startAug 2006
- Primary completionOct 2009
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Septal Defect, AtrialStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry A Latson, MD, Principal investigator, Joe DiMaggio Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581308
- Sponsor's protocol ID
- HLX 06-04
- Status last verified
- Feb 2018
- First submitted
- 20 Dec 2007
- Last updated
- 19 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GORE® HELEX® Septal Occluder Post-Approval Study
- ClinicalTrials.gov ID
- NCT00581308
- Acronym / sponsor ID
- HLX 06-04
- Conditions
- Septal Defect, Atrial
- Keywords
- atrial septal defect, septal occluder, HELEX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 7 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE® HELEX® Septal Occluder | Experimental | Device: GORE® HELEX® Septal OccluderSubjects who received a GORE® HELEX® Septal Occluder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ASD less than or equal to 18 mm.
Key exclusion criteria (2 listed)
- Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events.
- Unable to accommodate device delivery catheter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GORE® HELEX® Septal OccluderPercutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs) | Device | GORE® HELEX® Septal Occluder |
Primary outcome
Efficacy
Time frame: 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
Efficacy
Time frame: 36 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
Efficacy
Time frame: 60 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry A Latson, MD principal investigator
Joe DiMaggio Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GORE® HELEX® Septal Occluder in people with Septal Defect, Atrial, run by W.L.Gore & Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.