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Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER

Primary Purpose

Membranous Ventricular Septal Defects

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMPLATZER Membranous VSD Occluder
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Membranous Ventricular Septal Defects focused on measuring membranous, ventricular, septal, defect, VSD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota
  • Washington University Medical Center
  • Children's Hospital UN/CU)
  • Columbia University
  • Columbus Children's Hospital
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Closure of perimembranous Ventricular Septal Defects

Secondary Outcome Measures

Full Information

First Posted
December 20, 2007
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00578708
Brief Title
Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
September 2010 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Membranous Ventricular Septal Defects
Keywords
membranous, ventricular, septal, defect, VSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AMPLATZER Membranous VSD Occluder
Intervention Description
Device closure with the AMPLATZER Membranous VSD Occluder
Primary Outcome Measure Information:
Title
Closure of perimembranous Ventricular Septal Defects
Time Frame
5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
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
Children's Hospital UN/CU)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
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

12. IPD Sharing Statement

Learn more about this trial

Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER

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