Trial Outcomes & Findings for Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study (NCT NCT00647387)
NCT ID: NCT00647387
Last Updated: 2025-02-11
Results Overview
Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
At the end of the procedure
Results posted on
2025-02-11
Participant Flow
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.
Participant milestones
| Measure |
Muscular VSD Occluder
Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device
|
|---|---|
|
Overall Study
STARTED
|
92
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Muscular VSD Occluder
Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device
|
|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Unsuccessful implant
|
5
|
|
Overall Study
Device explanted
|
3
|
|
Overall Study
Other Reason
|
3
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Muscular VSD Occluder
n=92 Participants
Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device
|
|---|---|
|
Age, Continuous
|
6.2 years
STANDARD_DEVIATION 12.0 • n=92 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=92 Participants
|
|
Ventricular septal defects (VSD) type
Single VSD
|
45 Participants
n=92 Participants
|
|
Ventricular septal defects (VSD) type
Multiple VSD
|
32 Participants
n=92 Participants
|
|
Ventricular septal defects (VSD) type
Swiss Cheese
|
15 Participants
n=92 Participants
|
PRIMARY outcome
Timeframe: During the procedurePopulation: 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.
Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
Outcome measures
| Measure |
Muscular VSD Occluder
n=80 Participants
Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device
|
|---|---|
|
Primary Effectiveness End Point: Technical Success
|
75 Participants
|
PRIMARY outcome
Timeframe: At the end of the procedurePopulation: 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).
Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
Outcome measures
| Measure |
Muscular VSD Occluder
n=91 Participants
Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device
|
|---|---|
|
Primary Effectiveness End Point: Acute Procedure Success
|
71 Participants
|
PRIMARY outcome
Timeframe: 1-year follow-up visitPopulation: 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.
Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board).
Outcome measures
| Measure |
Muscular VSD Occluder
n=72 Participants
Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device
|
|---|---|
|
Primary Effectiveness End Point: Shunt Closure Success
|
68 Participants
|
PRIMARY outcome
Timeframe: Within 12 months of the procedurePopulation: 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.
The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.
Outcome measures
| Measure |
Muscular VSD Occluder
n=90 Participants
Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device
|
|---|---|
|
Primary Safety Endpoint
|
47 Participants
|
Adverse Events
Muscular VSD Occluder
Serious events: 51 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Muscular VSD Occluder
n=92 participants at risk
Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device
|
|---|---|
|
Investigations
Abnormal Lab Value
|
6.5%
6/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Edema
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Arterial Pulse Loss
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Asystole
|
1.1%
1/92 • 12 months
|
|
Nervous system disorders
Ataxia
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Atrial Flutter
|
1.1%
1/92 • 12 months
|
|
Infections and infestations
Bacteremia
|
1.1%
1/92 • 12 months
|
|
Blood and lymphatic system disorders
Bleeding
|
1.1%
1/92 • 12 months
|
|
Blood and lymphatic system disorders
Blood Loss
|
3.3%
3/92 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Tumor
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
2.2%
2/92 • 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
3.3%
3/92 • 12 months
|
|
Nervous system disorders
Cerebral Aneurysm
|
1.1%
1/92 • 12 months
|
|
Gastrointestinal disorders
Chronic Erosive Gastritis
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Common Cold/Upper Respiratory Tract Infection
|
2.2%
2/92 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Congestive Heart Failure
|
3.3%
3/92 • 12 months
|
|
Metabolism and nutrition disorders
Constipation
|
1.1%
1/92 • 12 months
|
|
Skin and subcutaneous tissue disorders
Cyanosis
|
1.1%
1/92 • 12 months
|
|
General disorders
Dehydration
|
2.2%
2/92 • 12 months
|
|
Product Issues
Device Closure of ASD
|
3.3%
3/92 • 12 months
|
|
Product Issues
Device Embolization
|
1.1%
1/92 • 12 months
|
|
Product Issues
Device Malposition or Malfunction
|
1.1%
1/92 • 12 months
|
|
Infections and infestations
Diarrhea
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
1/92 • 12 months
|
|
Investigations
EKG Abnormalities
|
1.1%
1/92 • 12 months
|
|
Investigations
Echo Finding
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Elective Cardiac Surgery
|
14.1%
13/92 • 12 months
|
|
Injury, poisoning and procedural complications
Elective Procedure
|
6.5%
6/92 • 12 months
|
|
Surgical and medical procedures
Elective Surgery
|
4.3%
4/92 • 12 months
|
|
Gastrointestinal disorders
Emesis/Vomiting
|
3.3%
3/92 • 12 months
|
|
General disorders
Failure to Thrive
|
2.2%
2/92 • 12 months
|
|
General disorders
Febrile Seizures
|
1.1%
1/92 • 12 months
|
|
General disorders
Fever
|
3.3%
3/92 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.1%
1/92 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
1.1%
1/92 • 12 months
|
|
General disorders
Headache
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Heart Failure
|
3.3%
3/92 • 12 months
|
|
Blood and lymphatic system disorders
Hematemesis
|
1.1%
1/92 • 12 months
|
|
Blood and lymphatic system disorders
Hemorrhage
|
1.1%
1/92 • 12 months
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
1.1%
1/92 • 12 months
|
|
Blood and lymphatic system disorders
Hypotension
|
1.1%
1/92 • 12 months
|
|
Vascular disorders
Intracerebral Haemorrhage
|
1.1%
1/92 • 12 months
|
|
Vascular disorders
Intraventricular Haemorrhage
|
1.1%
1/92 • 12 months
|
|
Vascular disorders
Ischemic Stroke
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Junctional Escape Rhythm/Intermittent Junctional Rhythm
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Mitral Valve Regurgitation/Mitral Insufficiency
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
PA Band Removal
|
7.6%
7/92 • 12 months
|
|
Cardiac disorders
Partial Obstruction of the Aorta with a Gradient > 10mm Hg
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.4%
5/92 • 12 months
|
|
Metabolism and nutrition disorders
Poor Nutrition
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Regurgitation/Pulmonary Insufficiency/Valvular Regurgitation: Pulmonary Valve
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Stenosis
|
1.1%
1/92 • 12 months
|
|
Renal and urinary disorders
Renal Insufficiency
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Residual Shunt
|
2.2%
2/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.2%
2/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Illness
|
3.3%
3/92 • 12 months
|
|
Infections and infestations
Respiratory Syncytial Virus Infection (RSV)
|
2.2%
2/92 • 12 months
|
|
Cardiac disorders
Right Ventricular Outflow Tract (RVOT) Obstruction
|
1.1%
1/92 • 12 months
|
|
Nervous system disorders
Seizure/Convulsions/Epilepsy
|
2.2%
2/92 • 12 months
|
|
Infections and infestations
Sepsis
|
1.1%
1/92 • 12 months
|
|
Infections and infestations
Septicemia
|
1.1%
1/92 • 12 months
|
|
Nervous system disorders
Stroke
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Systolic Dysfunction
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Third Degree Heart Block (Complete Heart Block)
|
1.1%
1/92 • 12 months
|
|
Blood and lymphatic system disorders
Thrombus
|
3.3%
3/92 • 12 months
|
|
Cardiac disorders
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve
|
1.1%
1/92 • 12 months
|
|
Renal and urinary disorders
Urinary Tract Infections
|
1.1%
1/92 • 12 months
|
|
Infections and infestations
Viral Syndrome
|
1.1%
1/92 • 12 months
|
|
Infections and infestations
Wound Dehiscence
|
1.1%
1/92 • 12 months
|
|
General disorders
Other
|
3.3%
3/92 • 12 months
|
Other adverse events
| Measure |
Muscular VSD Occluder
n=92 participants at risk
Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device
|
|---|---|
|
Cardiac disorders
Arterial Hypertension/Hypertension
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Cardiomegaly
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Chest Pain
|
2.2%
2/92 • 12 months
|
|
Product Issues
Device Malposition or Malfunction
|
1.1%
1/92 • 12 months
|
|
Blood and lymphatic system disorders
Diabetes Mellitus
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Diastolic Dysfunction
|
1.1%
1/92 • 12 months
|
|
Injury, poisoning and procedural complications
Elective Procedure
|
1.1%
1/92 • 12 months
|
|
General disorders
Fever
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
High Grade Block/Advanced AV Block
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Mobitz II Block
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Palpitations
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Pericardial Effusion
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Peripheral Arterial Occlusion
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.1%
1/92 • 12 months
|
|
Metabolism and nutrition disorders
Poor Nutrition
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Vein Stenosis
|
1.1%
1/92 • 12 months
|
|
Nervous system disorders
Seizure/Convulsions/Epilepsy
|
1.1%
1/92 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve
|
1.1%
1/92 • 12 months
|
Additional Information
Ryan Palmer, Director of Clinical Programs
Abbott Structural Heart
Phone: +1 651-202-8362
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place