Septal Defect, AtrialNCT01711983
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
A study testing GORE® CARDIOFORM Septal Occluder in people with Septal Defect, Atrial, run by W.L.Gore & Associates at 1 site in United States.
Trial summary
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Septal Defect, Atrial
- What is being tested?
- GORE® CARDIOFORM Septal Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 26 Nov 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASD less than or equal to 17 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.
United States1 site
University of Virginia, Children's Hospital Heart Center
Charlottesville, Virginia, 22908
About this study
Official title: GORE® Septal Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.
Read the detailed description
Ostium secundum atrial septal defects present as a persistent communication between the atria and are a common congenital cardiac anomaly accounting for approximately 10% of all congenital heart disease. They are one of the most common congenital heart defects to present in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure, pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated that approximately 10,000 new patients per year can be expected to have an ASD. Successful surgical repair of ASD has been performed for 50 years with continued improvement in technique and outcomes. King and Mills reported the first transcatheter closure of ASD in 1976, but the delivery system was quite large and impractical, especially for younger patients. With time, improvements in design concepts and materials discoveries have led to improved results in transcatheter closure systems. Several devices are now available commercially for transcatheter ASD closure.
- Conditions
- Septal Defect, Atrial
- Being tested
- GORE® CARDIOFORM Septal Occluder
- 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® CARDIOFORM Septal OccluderDevice
Percutaneous Atrial Septal Defect Closure
| Study group | Role | What they receive |
|---|---|---|
| Test Device | Experimental | ASD closure with the GORE® CARDIOFORM Septal Occluder Receives: Device: GORE® CARDIOFORM Septal Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With 6-Month Composite Clinical Success
Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components:
- Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder
- Safety Success:
- Freedom from any Serious Adverse Event (SAE) through 30 days post-procedure
- Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (195 days) post-procedure
- Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation
Measured: 6 months
Secondary outcomes (6)
Number of Subjects With Technical Success
Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder
Measured: During procedure; median duration 68 minutes
Number of Subjects With Procedure Success
Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure.
Measured: During procedure; median duration 68 minutes
Number of Subjects With 30-day SAE
Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure
Measured: 30 days
Number of Subjects With 6-Month Closure Success
Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.
Measured: 6 months
Number of Subjects With 12-Month Closure Success
Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 12-month evaluation.
Measured: 12 months
Number of Subjects With 36-Month Closure Success
Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startOct 2012
- Primary completion26 Nov 2018
- Study completion26 Nov 2018
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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- D. Scott Lim, MD, Principal investigator, University of Virginia, Children's Hospital Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711983
- Sponsor's protocol ID
- GSO 10-09
- Status last verified
- Aug 2020
- First submitted
- 11 Oct 2012
- Last updated
- 21 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GORE® Septal Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)
- ClinicalTrials.gov ID
- NCT01711983
- Acronym / sponsor ID
- GSO 10-09
- Conditions
- Septal Defect, Atrial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Posted 21 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.
Detailed description
Ostium secundum atrial septal defects present as a persistent communication between the atria and are a common congenital cardiac anomaly accounting for approximately 10% of all congenital heart disease. They are one of the most common congenital heart defects to present in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure, pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated that approximately 10,000 new patients per year can be expected to have an ASD. Successful surgical repair of ASD has been performed for 50 years with continued improvement in technique and outcomes. King and Mills reported the first transcatheter closure of ASD in 1976, but the delivery system was quite large and impractical, especially for younger patients. With time, improvements in design concepts and materials discoveries have led to improved results in transcatheter closure systems. Several devices are now available commercially for transcatheter ASD closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Device | Experimental | Device: GORE® CARDIOFORM Septal OccluderASD closure with the GORE® CARDIOFORM Septal Occluder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ASD less than or equal to 17 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® CARDIOFORM Septal OccluderPercutaneous Atrial Septal Defect Closure | Device | Test Device |
Primary outcome
Number of Subjects With 6-Month Composite Clinical Success
Time frame: 6 months
Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: 1. Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder 2. Safety Success: * Freedom from any Serious Adverse Event (SAE) through 30 days post-procedure * Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (195 days) post-procedure 3. Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation
6 secondary outcomes
Number of Subjects With Technical Success
Time frame: During procedure; median duration 68 minutes
Number of Subjects With Procedure Success
Time frame: During procedure; median duration 68 minutes
Number of Subjects With 30-day SAE
Time frame: 30 days
Number of Subjects With 6-Month Closure Success
Time frame: 6 months
Number of Subjects With 12-Month Closure Success
Time frame: 12 months
Number of Subjects With 36-Month Closure Success
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
D. Scott Lim, MD principal investigator
University of Virginia, Children's Hospital Heart Center
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® CARDIOFORM 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 21 Aug 2020. 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 21 Aug 2020). 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?
Number of Subjects With 6-Month Composite Clinical Success (time frame: 6 months). 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 21 Aug 2020.