Completed
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
What is being tested
Device closure with the AMPLATZER Muscular VSD Occluder
Device
Who is being recruted
Congenital Abnormalities+5
+ Cardiovascular Diseases
+ Heart Defects, Congenital
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: July 2000
Summary
Principal SponsorAbbott Medical Devices
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2000
Actual date on which the first participant was enrolled.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.
Official TitleClosure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Principal SponsorAbbott Medical Devices
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
91 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Congenital AbnormalitiesCardiovascular DiseasesHeart Defects, CongenitalHeart DiseasesHeart Septal DefectsHeart Septal Defects, VentricularCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCardiovascular Abnormalities
Criteria
2 inclusion criteria required to participate
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
7 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalDevice 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.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
Suspended
Suspended
Arnold Palmer Hospital
Orlando, United StatesSuspended
University of Chicago
Chicago, United StatesSuspended
University of Michigan Health System
Ann Arbor, United StatesCompleted11 Study Centers