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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00583791

Enrollment

Registered

2007-12-31

Start date

2000-07-31

Completion date

2009-11-30

Last updated

2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Septal Defects, Ventricular

Keywords

muscular, ventricular, septal, defects, VSD

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.

Interventions

DEVICEDevice closure with the AMPLATZER Muscular VSD Occluder

Device: AMPLATZER Muscular VSD Occluder

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Closure of Muscular Ventricular Septal Defects	5 years	Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder

Countries

United States

Participant flow

Participants by arm

Arm	Count
Main Cohort Patients with muscular VSDs that are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.	91
Total	91

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	6
Overall Study	Other	67

Baseline characteristics

Characteristic	Main Cohort
Age, Continuous	6.66 years
Region of Enrollment United States	91 participants
Sex: Female, Male Female	49 Participants
Sex: Female, Male Male	42 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	6 / 91
other Total, other adverse events	74 / 91
serious Total, serious adverse events	29 / 91

Outcome results

Primary