Atrial Septal DefectNCT00650936
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
A study testing AMPLATZER Septal Occluder in people with Atrial Septal Defect, run by Abbott Medical Devices at 51 sites in United States.
Trial summary
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Septal Defect
- What is being tested?
- AMPLATZER Septal Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 51 sitesUnited States
- Study dates
- Aug 2007to Jun 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she:
- is indicated for implantation with the AMPLATZER Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure),
- is willing and able to complete the follow-up requirements of this study, and
- signs the informed consent (or a legal representative signs the informed consent).
Who cannot join
None listed.
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Akron Children's Hospital
Akron, Ohio, 44308
University of Michigan
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta
Atlanta, Georgia, 30341
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
North Austin Medical Center
Austin, Texas, 78758
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
Sanger Heart & Vascular Institute/Carolinas Medical Center
Charlotte, North Carolina, 28203
Universtiy of Virginia
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
The Children's Hospital at Cleveland Clinic
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
Driscoll Children's Hospital
Corpus Christi, Texas, 78412
Children's Hospital of Michigan
Detroit, Michigan, 84201
INOVA Fairfax Hospital
Falls Church, Virginia, 22042
East Carolina University
Greenville, North Carolina, 27834
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Indiana University
Indianapolis, Indiana, 46202
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Jacksonville Pediatric Cardiovascular Center
Jacksonville, Florida, 32207
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky
Lexington, Kentucky, 40536
Kaiser Permanente
Los Angeles, California, 90027
Medical Center of the Rockies
Loveland, Colorado, 80538
Children's Hospital of Central California
Madera, California, 93636
LeBonheur Children's Hospital
Memphis, Tennessee, 38105
Miami Children's Hospital
Miami, Florida, 33165
Aurora Health Care
Milwaukee, Wisconsin, 53215
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Vanderbilt University-Children's
Nashville, Tennessee, 37232
Vanderbilt University
Nashville, Tennessee, 37232
Schneider Children's Hospital
New Hyde Park, New York, 11040
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
The New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021
Children's Hospital of New York-Presbyterian
New York, New York, 10032
Hope Children's Hospital
Oak Lawn, Illinois, 60453
Children's Hospital Oakland
Oakland, California, 94609
The Children's Hospital
Oklahoma City, Oklahoma, 73104
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Children's Hospital at Strong
Rochester, New York, 14618
University of California, San Francisco
San Francisco, California, 94143
Sacred Heart Children's Hospital
Spokane, Washington, 99204
Washington University
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33609
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Moffitt Heart and Vascular Group
Wormleysburg, Pennsylvania, 17043
About this study
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
- Conditions
- Atrial Septal Defect
- Being tested
- AMPLATZER Septal Occluder
- Keywords
- Atrial, Septal, Defect
- 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.
AMPLATZER Septal OccluderDevice
AMPLATZER Septal Occluder
| Study group | Role | What they receive |
|---|---|---|
| AMPLATZER Septal Occluder | Other | Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body). Receives: Device: AMPLATZER Septal Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With Two-year Device-related Hemodynamic Compromise
The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Measured: 24 months
Co-Primary Effectiveness Endpoint
The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met:
Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt < 2mm) without the need for surgical repair
Measured: 24 months
Co-Primary Safety Endpoint
The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startAug 2007
- Primary completionJun 2014
- Study completionJun 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650936
- Sponsor's protocol ID
- AGA-014
- Status last verified
- Jun 2019
- First submitted
- 31 Mar 2008
- Last updated
- 9 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Turner DR, Owada CY, Sang CJ Jr, Khan M, Lim DS. Closure of Secundum Atrial Septal Defects With the AMPLATZER Septal Occluder: A Prospective, Multicenter, Post-Approval Study. Circ Cardiovasc Interv. 2017 Aug;10(8):e004212. doi: 10.1161/CIRCINTERVENTIONS.116.004212.
PubMed 28801537
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
- ClinicalTrials.gov ID
- NCT00650936
- Acronym / sponsor ID
- AGA-014
- Conditions
- Atrial Septal Defect
- Keywords
- Atrial, Septal, Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Posted 25 Jun 2019
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 prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMPLATZER Septal Occluder | Other | Device: AMPLATZER Septal OccluderSubjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AMPLATZER Septal OccluderAMPLATZER Septal Occluder | Device | AMPLATZER Septal Occluder |
Primary outcome
Percent of Subjects With Two-year Device-related Hemodynamic Compromise
Time frame: 24 months
The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Co-Primary Effectiveness Endpoint
Time frame: 24 months
The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met: Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt < 2mm) without the need for surgical repair
Co-Primary Safety Endpoint
Time frame: 24 months
The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28801537Turner DR, Owada CY, Sang CJ Jr, Khan M, Lim DS. Closure of Secundum Atrial Septal Defects With the AMPLATZER Septal Occluder: A Prospective, Multicenter, Post-Approval Study. Circ Cardiovasc Interv. 2017 Aug;10(8):e004212. doi: 10.1161/CIRCINTERVENTIONS.116.004212.
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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.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMPLATZER Septal Occluder in people with Atrial Septal Defect, run by Abbott Medical Devices at 51 sites 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 4 inclusion and 0 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites 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 25 Jun 2019). 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?
Percent of Subjects With Two-year Device-related Hemodynamic Compromise (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00650936, which also lists 1 linked publication.
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 9 Jul 2019.