Back to resultsClosure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Primary Purpose
Heart Septal Defects, Ventricular
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device closure with the AMPLATZER Muscular VSD Occluder
Sponsored by
About this trial
This is an interventional treatment trial for Heart Septal Defects, Ventricular focused on measuring muscular, ventricular, septal, defects, VSD
Eligibility Criteria
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
Sites / Locations
- Children's Hospital
- Arnold Palmer Hospital
- University of Chicago
- University of Michigan Health System
- University of Minnesota
- Washington University Medical Center
- University of Nebraska Medical Center
- Columbus Children's Hospital
- Medical University of South Carolina
- Children's Hospital of the King's Daughters
- Children's Hospital and Regional Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Main Cohort
Arm Description
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.
Outcomes
Primary Outcome Measures
Closure of Muscular Ventricular Septal Defects
Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00583791
Brief Title
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Official Title
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Septal Defects, Ventricular
Keywords
muscular, ventricular, septal, defects, VSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Main Cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Device closure with the AMPLATZER Muscular VSD Occluder
Intervention Description
Device: AMPLATZER Muscular VSD Occluder
Primary Outcome Measure Information:
Title
Closure of Muscular Ventricular Septal Defects
Description
Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder
Time Frame
5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Levi, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Arnold Palmer Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0316
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2045
Country
United States
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Hospital and Regional Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
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