An interventional study of Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder) in Ventricular Septal Defects, sponsored by Abbott Medical Devices. Completed at 51 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment
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.
82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.
This study's enrollment of 92 is above the median of 72 across 51 interventional studies indexed under Heart Septal Defects.
Browse Heart Septal Defects studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following:
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:
Exclusion Criteria:
Implantation with the device
Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Device
Primary Effectiveness End Point: Technical Success
Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
Time frame: During the procedure
Primary Effectiveness End Point: Acute Procedure Success
Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
Time frame: At the end of the procedure
Primary Effectiveness End Point: Shunt Closure Success
Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board).
Time frame: 1-year follow-up visit
Primary Safety Endpoint
The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.
Time frame: Within 12 months of the procedure
Subject enrollment began on 14 May 2008 and concluded on 24 February 2020. A total of 92 subjects were enrolled at 28 investigational sites in the United States and Canada. The post-approval requirements included subject follow-up through 5-years post-procedure.
| Milestone | Muscular VSD Occluder |
|---|---|
| Started | 92 |
| Completed | 73 |
| Not completed | 19 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Unsuccessful implant | 5 |
| Withdrew: Device explanted | 3 |
| Withdrew: Other reason | 3 |
| Withdrew: Death | 2 |
Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
| Participants | Muscular VSD Occluder |
|---|---|
| Primary Effectiveness End Point: Technical Success | 75 |
Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
| Participants | Muscular VSD Occluder |
|---|---|
| Primary Effectiveness End Point: Acute Procedure Success | 71 |
Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board).
| Participants | Muscular VSD Occluder |
|---|---|
| Primary Effectiveness End Point: Shunt Closure Success | 68 |
The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.
| Participants | Muscular VSD Occluder |
|---|---|
| Primary Safety Endpoint | 47 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Muscular VSD Occluder | 2/92 (2.2%) | 51/92 (55.4%) | 17/92 (18.5%) |
| Event | Muscular VSD Occluder |
|---|---|
| Elective Cardiac SurgeryCardiac disorders | 13/92 |
| PA Band RemovalCardiac disorders | 7/92 |
| Abnormal Lab ValueInvestigations | 6/92 |
| Elective ProcedureInjury, poisoning and procedural complications | 6/92 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 5/92 |
| Elective SurgerySurgical and medical procedures | 4/92 |
| Blood LossBlood and lymphatic system disorders | 3/92 |
| Cardiac ArrestCardiac disorders | 3/92 |
| Congestive Heart FailureCardiac disorders | 3/92 |
| Device Closure of ASDProduct Issues | 3/92 |
| Event | Muscular VSD Occluder |
|---|---|
| Chest PainCardiac disorders | 2/92 |
| Arterial Hypertension/HypertensionCardiac disorders | 1/92 |
| CardiomegalyCardiac disorders | 1/92 |
| Device Malposition or MalfunctionProduct Issues | 1/92 |
| Diabetes MellitusBlood and lymphatic system disorders | 1/92 |
| Diastolic DysfunctionCardiac disorders | 1/92 |
| Elective ProcedureInjury, poisoning and procedural complications | 1/92 |
| FeverGeneral disorders | 1/92 |
| High Grade Block/Advanced AV BlockCardiac disorders | 1/92 |
| Mobitz II BlockCardiac disorders | 1/92 |
Analysis included prospectively (n=80) and retrospectively (n=12) enrolled subjects.
| Age, Continuous(years) | Muscular VSD Occluder |
|---|---|
| Mean | 6.2 ± 12.0 |
| Sex: Female, Male(Participants) | Muscular VSD Occluder |
|---|---|
| Female | 50 |
| Male | 42 |
| Race and Ethnicity Not Collected(Participants) | Muscular VSD Occluder |
|---|
| Ventricular septal defects (VSD) type(Participants) | Muscular VSD Occluder |
|---|---|
| Single VSD | 45 |
| Multiple VSD | 32 |
| Swiss Cheese | 15 |
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