Heart Septal Defects, VentricularNCT00583791
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
A study testing Device closure with the AMPLATZER Muscular VSD Occluder in people with Heart Septal Defects, Ventricular, run by Abbott Medical Devices at 11 sites in United States.
Trial summary
The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Septal Defects, Ventricular
- What is being tested?
- Device closure with the AMPLATZER Muscular VSD Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2000to Nov 2009
- 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 with hemodynamically significant muscular VSD's (demonstrated by echocardiography or angiography), either isolated or in conjunction with other congenital heart defects
- Age < 18 years old
Who cannot join
- Less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
- Patients with severely increased pulmonary vascular resistance above 7 woods units and a right-to-left shunt and documented irreversible pulmonary vascular disease
- Patients with perimembranous (close to the aortic valve) VSD
- Patients < 3 kg
- Patients with sepsis (local/generalized)
- Patients with gastritis, gastric ulcer, duodenal ulcer, bleeding disorders etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months
- Inability to obtain informed consent
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109-0316
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637-1470
Columbus Children's Hospital
Columbus, Ohio, 43205
Children's Hospital
Denver, Colorado, 80218
University of Minnesota
Minneapolis, Minnesota, 55455
Children's Hospital of the King's Daughters
Norfolk, Virginia, 30322
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2045
Arnold Palmer Hospital
Orlando, Florida, 32806
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
Washington University Medical Center
St Louis, Missouri, 63110
About this study
The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.
Read the detailed description
The objective of this feasibility study is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.
- Conditions
- Heart Septal Defects, Ventricular
- Being tested
- Device closure with the AMPLATZER Muscular VSD Occluder
- Keywords
- muscular, ventricular, septal, defects, VSD
- Medical subject headings
- Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device closure with the AMPLATZER Muscular VSD OccluderDevice
Device: AMPLATZER Muscular VSD Occluder
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | Experimental | Device closure with the AMPLATZER Muscular VSD Occluder for patients with muscular ventricular septal defects which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects. Receives: Device: Device closure with the AMPLATZER Muscular VSD Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of Muscular Ventricular Septal Defects
Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder
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 posted31 Dec 2007 (estimated)
- Study startJul 2000
- Primary completionOct 2008
- Study completionNov 2009
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 Heart Septal Defects, VentricularStudies 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Levi, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583791
- Sponsor's protocol ID
- AGA-005
- Other IDs
- G990289
- Status last verified
- Feb 2016
- First submitted
- 20 Dec 2007
- Last updated
- 28 Jun 2019
- 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 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
- ClinicalTrials.gov ID
- NCT00583791
- Acronym / sponsor ID
- AGA-005
- Conditions
- Heart Septal Defects, Ventricular
- Keywords
- muscular, ventricular, septal, defects, VSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2000
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Posted 28 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 objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.
Detailed description
The objective of this feasibility study is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | Experimental | Device: Device closure with the AMPLATZER Muscular VSD OccluderDevice closure with the AMPLATZER Muscular VSD Occluder for patients with muscular ventricular septal defects which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with hemodynamically significant muscular VSD's (demonstrated by echocardiography or angiography), either isolated or in conjunction with other congenital heart defects
- Age < 18 years old
Key exclusion criteria (7 listed)
- Less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
- Patients with severely increased pulmonary vascular resistance above 7 woods units and a right-to-left shunt and documented irreversible pulmonary vascular disease
- Patients with perimembranous (close to the aortic valve) VSD
- Patients < 3 kg
- Patients with sepsis (local/generalized)
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 |
|---|---|---|
| Device closure with the AMPLATZER Muscular VSD OccluderDevice: AMPLATZER Muscular VSD Occluder | Device | Main Cohort |
Primary outcome
Closure of Muscular Ventricular Septal Defects
Time frame: 5 years
Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- 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.
Daniel Levi, MD principal investigator
University of California, Los Angeles
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device closure with the AMPLATZER Muscular VSD Occluder in people with Heart Septal Defects, Ventricular, run by Abbott Medical Devices at 11 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 2 inclusion and 7 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 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 28 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?
Closure of Muscular 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 28 Jun 2019.