Trial Outcomes & Findings for Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder (NCT NCT00583791)
NCT ID: NCT00583791
Last Updated: 2019-06-28
Results Overview
Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
5 years
Results posted on
2019-06-28
Participant Flow
Participant milestones
| Measure |
Main Cohort
Treatment of muscular VSDs (ventricular septal defects) which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
|
|---|---|
|
Overall Study
STARTED
|
91
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
73
|
Reasons for withdrawal
| Measure |
Main Cohort
Treatment of muscular VSDs (ventricular septal defects) which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
|
|---|---|
|
Overall Study
Other
|
67
|
|
Overall Study
Death
|
6
|
Baseline Characteristics
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Baseline characteristics by cohort
| Measure |
Main Cohort
n=91 Participants
Patients with muscular VSDs that are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
|
|---|---|
|
Age, Continuous
|
6.66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsClosure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder
Outcome measures
| Measure |
Main Cohort
n=91 Participants
Treatment of muscular VSDs (ventricular septal defects) which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects
|
|---|---|
|
Closure of Muscular Ventricular Septal Defects
|
91 participants
|
Adverse Events
Main Cohort
Serious events: 29 serious events
Other events: 74 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Main Cohort
n=91 participants at risk
Treatment of muscular VSDs (ventricular septal defects) which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
|
|---|---|
|
General disorders
AE Code Not Specified
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Anemias
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Anemias Caused By Blood Loss
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Arterial Pulse Loss
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Blood Loss
|
5.5%
5/91 • Number of events 5
|
|
General disorders
Blood Transfusion
|
5.5%
5/91 • Number of events 5
|
|
General disorders
Bradycardia
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Cardiac Arrest
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Cardiac Perforation
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Cardiac Surgery
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Cardiomyopathy
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Death1
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Delivery System Failure
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Device Collapse2
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Device Embolization3
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Dual Pacemaker
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Encephalopathy
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Hematoma
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Hemostasis and Coagulation Disorders
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Hypotension
|
5.5%
5/91 • Number of events 5
|
|
General disorders
Mobitz II Block
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Paroxysmal Ventricular Tachycardia
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Poor Device Position
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Seizures
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Stroke
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Subaortic Stenosis
|
2.2%
2/91 • Number of events 4
|
|
General disorders
Third Degree Heart Block (Complete Heart Block)
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Vocal cord paralysis
|
1.1%
1/91 • Number of events 1
|
Other adverse events
| Measure |
Main Cohort
n=91 participants at risk
Treatment of muscular VSDs (ventricular septal defects) which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
|
|---|---|
|
General disorders
AE Code Not Specified
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Acidosis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Acute Bronchitis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Acute Erosive Gastritis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Acute Otitis Media
|
2.2%
2/91 • Number of events 3
|
|
General disorders
Acute Pancreatitis
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Acute Pharyngitis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Anemias
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Anemias Caused By Blood Loss
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Anemias Caused By Deficient Erythropoiesis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Anesthesia Reaction
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Arrhythmias
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Arterial Pulse Loss
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Asthma
|
4.4%
4/91 • Number of events 4
|
|
General disorders
Atelectasis
|
8.8%
8/91 • Number of events 8
|
|
General disorders
Atopic Dermatitis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Atrial Fibrillation
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Atrial Flutter
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Bacteremia
|
4.4%
4/91 • Number of events 4
|
|
General disorders
Bacterial Infections
|
4.4%
4/91 • Number of events 6
|
|
General disorders
Biventricular Hypertrophy/Combined Ventricular Hypertrophy
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Blood Loss
|
5.5%
5/91 • Number of events 5
|
|
General disorders
Blood Transfusion
|
6.6%
6/91 • Number of events 6
|
|
General disorders
Bradycardia
|
4.4%
4/91 • Number of events 4
|
|
General disorders
Broad QRS Complex Arrhythmias
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Bronchomalacia
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Bruise/Purpura Simplex
|
1.1%
1/91 • Number of events 1
|
|
General disorders
CVVH (Continuous Veno Venous Hemofiltration)
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Cardiac Arrest
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Cardiac Perforation
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Cardiac Cath
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Cardiac Surgery
|
14.3%
13/91 • Number of events 14
|
|
General disorders
Cardiomyopathy
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Cellulitis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Chest Pain
|
4.4%
4/91 • Number of events 5
|
|
General disorders
Cholecystitis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Chronic Recurrent Drainage/Oozing
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Circumcision
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Coarctation of Aorta
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Cobra Formation
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Common Cold/Upper Respiratory Tract Infection
|
9.9%
9/91 • Number of events 16
|
|
General disorders
Congestive Heart Failure
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Conjunctivitis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Cough
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Croup
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Cyanosis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Death*
|
4.4%
4/91 • Number of events 4
|
|
General disorders
Dehydration
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Delivery System Failure
|
4.4%
4/91 • Number of events 4
|
|
General disorders
Device Collapse
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Device Embolization
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Diabetes Mellitus
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Dizziness
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Dual Pacemaker
|
2.2%
2/91 • Number of events 3
|
|
General disorders
Dyspnea
|
4.4%
4/91 • Number of events 4
|
|
General disorders
Edema
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Elective Surgery
|
2.2%
2/91 • Number of events 3
|
|
General disorders
Elective Adenoidectomy with Tympanostomy Tubes
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Encephalopathy
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Fever
|
4.4%
4/91 • Number of events 7
|
|
General disorders
First Degree Heart/AV Block/Cardiac Arrhythmia - 1st Degree AV Block
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Foreign Bodies
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Fracture
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Functional Vomiting
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Fungal Pneumonia
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Gastroesophageal Reflux Disease
|
4.4%
4/91 • Number of events 4
|
|
General disorders
Gastrointestinal Bleeding
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Gastrostomy Tube
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Headache
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Hematoma
|
4.4%
4/91 • Number of events 4
|
|
General disorders
Hematoma of the Groin
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Hematuria
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Hemostasis and Coagulation Disorders
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Hyperglycemia
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Hypotension
|
11.0%
10/91 • Number of events 10
|
|
General disorders
Incomplete Right Bundle Branch Block
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Ingestion
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Interventricular Conduction Delay
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Junctional Escape Beat
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Junctional Escape Rhythm/Intermittent Junctional Rhythm
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Lacerations
|
1.1%
1/91 • Number of events 2
|
|
General disorders
Left Ventricular Hypertrophy
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Liver Enlargement
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Meatal Stenosis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Memory Loss
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Metabolic Alkalosis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Migraine
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Mild Mitral Valve Regurgitation
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Mild Tricuspid Regurgitation
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Miscellaneous Infections
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Mitral Valve Regurgitation/Mitral Insufficiency
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Mobitz II Block
|
5.5%
5/91 • Number of events 5
|
|
General disorders
Moderate Tricuspid Regurgitation
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Musculoskeletal Pain
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Myalgias
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Nausea
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Nonspecific Intraventricular Conduction Defects
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Nose Bleed
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Other
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Otitis Media
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Pallor
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Palpitations
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Paroxysmal Junctional Tachycardia
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Paroxysmal Ventricular Tachycardia
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Pericardial Effusion
|
4.4%
4/91 • Number of events 5
|
|
General disorders
Pharyngitis
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Pleural Effusions
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Pleuropericardial Fluid
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Pneumonia
|
4.4%
4/91 • Number of events 6
|
|
General disorders
Pneumonia Caused By Gram-Negative Bacilli
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Pneumothorax
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Poor Device Position
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Premature Atrial Beat
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Premature Ventricular Contraction
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Pulmonary Congestion
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Pulmonary Hemorrhage
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Pulmonary Hypertension
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Pulmonary Stenosis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Pulmonary Edema
|
6.6%
6/91 • Number of events 7
|
|
General disorders
Rash
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Renal Failure
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Respiratory Synctial Virus Infection (RSV)
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Right Bundle Branch Block/Complete Right Bundle Branch Block
|
12.1%
11/91 • Number of events 13
|
|
General disorders
Right Ventricular Hypertrophy
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Scoliosis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Seizure/Convulsions/Epilepsy
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Seizures
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Sinusitis
|
5.5%
5/91 • Number of events 6
|
|
General disorders
Stridor
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Stroke
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Subaortic Stenosis
|
2.2%
2/91 • Number of events 4
|
|
General disorders
Subglottic Edema 2 to Prolonged Intubation
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Syncope
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Tachypnea
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Third Degree Heart Block (Complete Heart Block)
|
5.5%
5/91 • Number of events 6
|
|
General disorders
Trace Tricuspid Regurgitation (Tricuspid Incompetence or Ins)
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Tracheostomy
|
2.2%
2/91 • Number of events 2
|
|
General disorders
Trigeminy
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Urinary Tract Infections
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Vascular Congestion
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Venous Thrombosis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Ventricular Escape Rhythm
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Viral Gastroenteritis
|
3.3%
3/91 • Number of events 4
|
|
General disorders
Viral Pneumonia
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Vocal Cord Paralysis
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Vomiting
|
4.4%
4/91 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place