Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder

Not Applicable

Completed

• Conditions: Heart Septal Defects, Ventricular
• Interventions: Device: Device closure with the AMPLATZER Muscular VSD Occluder

• Registration Number: NCT00583791
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2000-07
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-31
• Primary Completion: 2008-10
• Study Completion: 2009-11
• Results First Submitted: 2013-12-20
• Status Verified: 2016-02
• Results First Submitted QC: 2019-06-07
• Last Update Submitted: 2019-06-07
• Results First Posted: 2019-06-28
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main Cohort	Device closure with the AMPLATZER Muscular VSD Occluder	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.

Primary Outcome Measures

Name	Time	Method
Closure of Muscular Ventricular Septal Defects	5 years	Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder

Trial Locations

Locations (11)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Arnold Palmer Hospital; 🇺🇸 Orlando, Florida, United States

Children's Hospital; 🇺🇸 Denver, Colorado, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Columbus Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Children's Hospital of the King's Daughters; 🇺🇸 Norfolk, Virginia, United States

Children's Hospital and Regional Medical Center; 🇺🇸 Seattle, Washington, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States