NCT00583791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
9.7 years until next milestone

Results Posted

Study results publicly available

June 28, 2019

Completed
Last Updated

June 28, 2019

Status Verified

February 1, 2016

Enrollment Period

8.3 years

First QC Date

December 20, 2007

Results QC Date

December 20, 2013

Last Update Submit

June 7, 2019

Conditions

Heart Septal Defects, Ventricular

Keywords

muscularventricularseptaldefectsVSD

Outcome Measures

Primary Outcomes (1)

  • Closure of Muscular Ventricular Septal Defects

    Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder

    5 years

Study Arms (1)

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.

Device: Device closure with the AMPLATZER Muscular VSD Occluder

Interventions

Device closure with the AMPLATZER Muscular VSD OccluderDEVICE

Device: AMPLATZER Muscular VSD Occluder

Main Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Children's Hospital

Denver, Colorado, 80218, United States

Location

Arnold Palmer Hospital

Orlando, Florida, 32806, United States

Location

University of Chicago

Chicago, Illinois, 60637-1470, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109-0316, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-2045, United States

Location

Columbus Children's Hospital

Columbus, Ohio, 43205, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 30322, United States

Location

Children's Hospital and Regional Medical Center

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Maren Wagner
Organization
Abbott
maren.wagner@abbott.com
6517565585

Study Officials

  • Daniel Levi, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

July 1, 2000

Primary Completion

October 1, 2008

Study Completion

November 1, 2009

Last Updated

June 28, 2019

Results First Posted

June 28, 2019

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(11)