Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study

The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.

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Key information

Conditions

Ventricular Septal Defects Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's Hospital, Vancouver, Bristish Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following:

Large volume left to right shunt (Qp/Qs >2:1),
Pulmonary hypertension (PA pressure >50% systemic) and/or
Clinical symptoms of congestive heart failure
Banding of the pulmonary artery(ies) and in the opinion of the treating investigator closure of the VSD is clinically warranted.
Subjects must meet at least one of the following criteria to be considered high risk for standard transatrial or transarterial surgical closure based on anatomical conditions:

Left ventriculotomy or an extensive right ventriculotomy,
Failed previous VSD closure,
Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or
Posterior apical VSDs covered by trabeculae.
Overall medical condition
Subject/legally authorized representative has signed the informed consent
Subject/legally authorized representative is willing to complete the follow-up requirements of this study

Exclusion criteria

Subjects with defects less than 4 mm distance from the semilunar (aortic and pulmonary) or atrioventricular valves (mitral and tricuspid)
Subjects with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
Subjects with perimembranous (close to the aortic valve) VSD
Subjects with post-infarction VSD
Subjects who weigh < 5.2 kg
Subjects with sepsis (local/generalized)
Subjects with active bacterial infections
Subjects with contraindications to anti-platelets

Treatment and study plan

Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)

Device

Primary outcomes

Primary Effectiveness End Point: Technical Success

Time frame: During the procedure

Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
Primary Effectiveness End Point: Acute Procedure Success

Time frame: At the end of the procedure

Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
Primary Effectiveness End Point: Shunt Closure Success

Time frame: 1-year follow-up visit

Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board).
Primary Safety Endpoint

Time frame: Within 12 months of the procedure

The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: VPA

Important dates

Study start: 2008
Primary completion: 2024
Study completion: 2024
First posted: Mar 31, 2008
Registry last updated: Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed