Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
June 7, 2019 updated by: Abbott Medical Devices
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
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
-
-
Colorado
-
Denver, Colorado, United States, 80218
- Children's Hospital
-
-
Florida
-
Orlando, Florida, United States, 32806
- Arnold Palmer Hospital
-
-
Illinois
-
Chicago, Illinois, United States, 60637-1470
- University of Chicago
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109-0316
- University of Michigan Health System
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University Medical Center
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198-2045
- University Of Nebraska Medical Center
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Columbus Children's Hospital
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Virginia
-
Norfolk, Virginia, United States, 30322
- Children's Hospital of The King's Daughters
-
-
Washington
-
Seattle, Washington, United States, 98105
- Children's Hospital and Regional Medical Center
-
-
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 muscular VSD's (demonstrated by echocardiography or angiography), either isolated or in conjunction with other congenital heart defects
- Age < 18 years old
Exclusion Criteria:
- 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
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: Main Cohort
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.
|
Device: AMPLATZER Muscular VSD Occluder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Closure of Muscular Ventricular Septal Defects
Time Frame: 5 years
|
Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Levi, MD, University of California, Los Angeles
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
July 1, 2000
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
December 31, 2007
Study Record Updates
Last Update Posted (Actual)
June 28, 2019
Last Update Submitted That Met QC Criteria
June 7, 2019
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGA-005
- G990289
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.