- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00578708
Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER
February 1, 2019 updated by: Abbott Medical Devices
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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-
Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University Medical Center
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Nebraska
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Omaha, Nebraska, United States, 68114
- Children's Hospital UN/CU)
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New York
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New York, New York, United States, 10032
- Columbia University
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Ohio
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Columbus, Ohio, United States, 43205
- Columbus Children's Hospital
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with hemodynamically significant Perimembranous ventricular septal defects
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Device closure with the AMPLATZER Membranous VSD Occluder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Closure of perimembranous Ventricular Septal Defects
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 20, 2007
First Posted (Estimate)
December 21, 2007
Study Record Updates
Last Update Posted (Actual)
February 4, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGA-008
- G020202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Membranous Ventricular Septal Defects
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Abbott Medical DevicesNo longer availableMembranous | Ventricular | Septal | Defects | VSD
-
Xijing HospitalCompletedVentricular Septal Defects
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Nanjing Medical UniversityCompletedPediatric Ventricular Septal Defects
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Abbott Medical DevicesActive, not recruitingVentricular Septal DefectsUnited States, Canada
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Chinese Academy of Medical Sciences, Fuwai HospitalUnknownPerimembranous Ventricular Septal DefectChina
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Nationwide Children's HospitalCompletedTetralogy of Fallot (TOF) | Ventricular Septal Defects (VSD) | Atrioventricular Septal Defects (AVSD)United States
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Asklepion Pharmaceuticals, LLCCompletedAtrial Septal Defect | Atrioventricular Septal Defect | Ventricular Septal DefectUnited States
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Occlutech International ABRecruitingMuscular Ventricular Septal DefectTurkey
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Bark Technology LLPRecruitingCardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)Kazakhstan
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Children's Healthcare of AtlantaTerminatedVentricular Septal Defects | Persistent Common Atrioventricular CanalUnited States
Clinical Trials on AMPLATZER Membranous VSD Occluder
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Abbott Medical DevicesNo longer availableMembranous | Ventricular | Septal | Defects | VSD
-
Abbott Medical DevicesActive, not recruitingVentricular Septal DefectsUnited States, Canada
-
Abbott Medical DevicesApproved for marketingVentricular | Septal | Defects | VSD | Muscular
-
Abbott Medical DevicesCompletedPost-Infarction Ventricular Septal DefectUnited States
-
Abbott Medical DevicesRecruitingPFO - Patent Foramen Ovale | VSD - Muscular Ventricular Septal Defect | PIVSD - Post Infarct Muscular Ventricular Septal Defect | ASD - Atrial Septal DefectSpain, Germany, Poland, France, Italy, Netherlands, Switzerland
-
Abbott Medical DevicesCompletedHeart Septal Defects, VentricularUnited States
-
Abbott Medical DevicesJapanese society of Congenital Interventional CardiologyRecruitingPatent Ductus ArteriosusJapan
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Abbott Medical DevicesActive, not recruitingPFO - Patent Foramen OvaleJapan
-
Lifetech Scientific (Shenzhen) Co., Ltd.Active, not recruiting
-
Chinese Academy of Medical Sciences, Fuwai HospitalShanghai Shape Memory Alloy Co., Ltd.UnknownVentricular Septal DefectChina