Brief Title
Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
Brief Summary
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.
Study Type
Interventional
Primary Outcome
The primary safety objective is to evaluate the proportion of subjects experiencing a major adverse event within 12 months of the procedure. Subjects will be followed for 5 years post implant.
Condition
Ventricular Septal Defects
Intervention
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Study Arms / Comparison Groups
1
Description: Implantation with the device
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
91
Start Date
March 2008
Completion Date
August 2025
Primary Completion Date
August 2025
Eligibility Criteria
Inclusion Criteria: 1. complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following: 1. Large volume left to right shunt (Qp/Qs >2:1), 2. Pulmonary hypertension (PA pressure >50% systemic) and/or 3. Clinical symptoms of congestive heart failure 4. Banding of the pulmonary artery(ies) and in the opinion of the treating investigator closure of the VSD is clinically warranted. 2. 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: 1. Left ventriculotomy or an extensive right ventriculotomy, 2. Failed previous VSD closure, 3. Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or 4. Posterior apical VSDs covered by trabeculae. 5. Overall medical condition 3. Subject/legally authorized representative has signed the informed consent 4. Subject/legally authorized representative is willing to complete the follow-up requirements of this study Exclusion Criteria: 1. Subjects with defects less than 4 mm distance from the semilunar (aortic and pulmonary) or atrioventricular valves (mitral and tricuspid) 2. Subjects with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease 3. Subjects with perimembranous (close to the aortic valve) VSD 4. Subjects with post-infarction VSD 5. Subjects who weigh < 5.2 kg 6. Subjects with sepsis (local/generalized) 7. Subjects with active bacterial infections 8. Subjects with contraindications to anti-platelets
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Maren Wagner, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00647387
Organization ID
AGA-016
Responsible Party
Sponsor
Study Sponsor
Abbott Medical Devices
Study Sponsor
Maren Wagner, Study Director, Abbott
Verification Date
August 2022