Ventricular Septal Defects
Conditions
Keywords
muscular, ventricular, septal, defects, VSD
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.
Interventions
DEVICEMuscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Device
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness End Point: Technical Success | 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 | 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 | 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 | Within 12 months of the procedure | The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure. |
Countries
Canada, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Muscular VSD Occluder Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Device explanted | 3 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Other Reason | 3 |
| Overall Study | Unsuccessful implant | 5 |
Baseline characteristics
| Characteristic | Muscular VSD Occluder | — |
|---|---|---|
| Age, Continuous | 6.2 years STANDARD_DEVIATION 12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 42 Participants | — |
| Ventricular septal defects (VSD) type Multiple VSD | 32 Participants | — |
| Ventricular septal defects (VSD) type Single VSD | 45 Participants | — |
| Ventricular septal defects (VSD) type Swiss Cheese | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 92 |
| other Total, other adverse events | 17 / 92 |
| serious Total, serious adverse events | 51 / 92 |
Outcome results
Primary
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
Population: The analysis population included all subjects who had an attempted device placement (defined as the delivery system enters the subject's body in an attempt to place a device).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Muscular VSD Occluder | Primary Effectiveness End Point: Acute Procedure Success | 71 Participants |
Primary
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
Population: The analysis of the shunt closure success included all enrolled subjects who had an attempted device placement (defined as the delivery system enters the subject's body in an attempt to place a device) and a 1-year follow-up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Muscular VSD Occluder | Primary Effectiveness End Point: Shunt Closure Success | 68 Participants |
Primary
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
Population: The analysis population included all prospectively enrolled subjects only (N=80) who have an attempted device placement (defined as the delivery system enters the subject's body in an attempt to place a device), as retrospectively enrolled subjects were selected based on established Technical Success.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Muscular VSD Occluder | Primary Effectiveness End Point: Technical Success | 75 Participants |
Primary
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
Population: The Primary Safety endpoint included all enrolled subjects except for withdrawn subjects with no adverse events within the first 12 months and consented screen failures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Muscular VSD Occluder | Primary Safety Endpoint | 47 Participants |