Membranous Ventricular Septal DefectsPhase 1NCT00578708
Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER
A Phase 1 study testing AMPLATZER Membranous VSD Occluder in people with Membranous Ventricular Septal Defects, run by Abbott Medical Devices at 6 sites in United States.
Trial summary
The purpose of this feasibility study is to investigate the safety of the AMPLATZER® Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous Ventricular Septal Defects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Membranous Ventricular Septal Defects
- What is being tested?
- AMPLATZER Membranous VSD Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2003to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 with hemodynamically significant Perimembranous ventricular septal defects
Who cannot join
- Patients < 8 kg
- Supracristal ventricular septal defects
- Left ventricle to right atrium shunting
- Prolapse of the aortic valve
- Right to left shunting through the defect
- Perimembranous VSD with an aneurysm and multiple shunts which can not be successfully closed with one device
Show all 12Show fewer
- Patients with <2mm aortic rim
- Sepsis (local/generalized)
- Complex heart lesions such as atrioventricular canal defect or Tetralogy of Fallot.
- Patients who are ASA intolerant
- Unable to be followed for the duration of the clinical trial
- Inability to obtain informed consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Columbus Children's Hospital
Columbus, Ohio, 43205
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia University
New York, New York, 10032
Children's Hospital UN/CU)
Omaha, Nebraska, 68114
Washington University Medical Center
St Louis, Missouri, 63110
About this study
The purpose of this feasibility study is to investigate the safety of the AMPLATZER® Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous Ventricular Septal Defects.
- Conditions
- Membranous Ventricular Septal Defects
- Being tested
- AMPLATZER Membranous VSD Occluder
- Keywords
- membranous, ventricular, septal, defect, VSD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLATZER Membranous VSD OccluderDevice
Device closure with the AMPLATZER Membranous VSD Occluder
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: AMPLATZER Membranous VSD Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of perimembranous Ventricular Septal Defects
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 posted21 Dec 2007 (estimated)
- Study startSep 2003
- Primary completionMar 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Membranous Ventricular Septal DefectsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT00578708
- Sponsor's protocol ID
- AGA-008
- Other IDs
- G020202
- Status last verified
- Feb 2019
- First submitted
- 20 Dec 2007
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER
- ClinicalTrials.gov ID
- NCT00578708
- Acronym / sponsor ID
- AGA-008
- Conditions
- Membranous Ventricular Septal Defects
- Keywords
- membranous, ventricular, septal, defect, VSD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Not posted in the source record
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 feasibility study is to investigate the safety of the AMPLATZER® Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous Ventricular Septal Defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: AMPLATZER Membranous VSD Occluder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with hemodynamically significant Perimembranous ventricular septal defects
Key exclusion criteria (12 listed)
- Patients < 8 kg
- Supracristal ventricular septal defects
- Left ventricle to right atrium shunting
- Prolapse of the aortic valve
- Right to left shunting through the defect
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 Membranous VSD OccluderDevice closure with the AMPLATZER Membranous VSD Occluder | Device | 1 |
Primary outcome
Closure of perimembranous Ventricular Septal Defects
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMPLATZER Membranous VSD Occluder in people with Membranous Ventricular Septal Defects, run by Abbott Medical Devices at 6 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 1 inclusion and 12 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Closure of perimembranous Ventricular Septal Defects (time frame: 5 years). 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 4 Feb 2019.