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Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00583791
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Septal Defects, Ventricular
Intervention Device: Device closure with the AMPLATZER Muscular VSD Occluder
Enrollment 91
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Main Cohort
Hide Arm/Group Description Treatment of muscular VSDs (ventricular septal defects) which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
Period Title: Overall Study
Started 91
Completed 18
Not Completed 73
Reason Not Completed
Other             67
Death             6
Arm/Group Title Main Cohort
Hide Arm/Group Description Patients with muscular VSDs that are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
Overall Number of Baseline Participants 91
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 91 participants
6.66
(0.03 to 54.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants
Female
49
  53.8%
Male
42
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 91 participants
91
1.Primary Outcome
Title Closure of Muscular Ventricular Septal Defects
Hide Description Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Main Cohort
Hide Arm/Group Description:
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 Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: participants
91
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Main Cohort
Hide Arm/Group Description Treatment of muscular VSDs (ventricular septal defects) which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
All-Cause Mortality
Main Cohort
Affected / at Risk (%)
Total   6/91 (6.59%)    
Hide Serious Adverse Events
Main Cohort
Affected / at Risk (%) # Events
Total   29/91 (31.87%)    
General disorders   
AE Code Not Specified  1/91 (1.10%)  1
Anemias  1/91 (1.10%)  1
Anemias Caused By Blood Loss  2/91 (2.20%)  2
Arterial Pulse Loss  2/91 (2.20%)  2
Blood Loss  5/91 (5.49%)  5
Blood Transfusion  5/91 (5.49%)  5
Bradycardia  1/91 (1.10%)  1
Cardiac Arrest  2/91 (2.20%)  2
Cardiac Perforation  2/91 (2.20%)  2
Cardiac Surgery  1/91 (1.10%)  1
Cardiomyopathy  1/91 (1.10%)  1
Death1  3/91 (3.30%)  3
Delivery System Failure  2/91 (2.20%)  2
Device Collapse2  1/91 (1.10%)  1
Device Embolization3  2/91 (2.20%)  2
Dual Pacemaker  1/91 (1.10%)  1
Encephalopathy  1/91 (1.10%)  1
Hematoma  1/91 (1.10%)  1
Hemostasis and Coagulation Disorders  1/91 (1.10%)  1
Hypotension  5/91 (5.49%)  5
Mobitz II Block  1/91 (1.10%)  1
Paroxysmal Ventricular Tachycardia  1/91 (1.10%)  1
Poor Device Position  1/91 (1.10%)  1
Seizures  1/91 (1.10%)  1
Stroke  2/91 (2.20%)  2
Subaortic Stenosis  2/91 (2.20%)  4
Third Degree Heart Block (Complete Heart Block)  3/91 (3.30%)  3
Vocal cord paralysis  1/91 (1.10%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Main Cohort
Affected / at Risk (%) # Events
Total   74/91 (81.32%)    
General disorders   
AE Code Not Specified  1/91 (1.10%)  1
Acidosis  1/91 (1.10%)  1
Acute Bronchitis  1/91 (1.10%)  1
Acute Erosive Gastritis  1/91 (1.10%)  1
Acute Otitis Media  2/91 (2.20%)  3
Acute Pancreatitis  2/91 (2.20%)  2
Acute Pharyngitis  1/91 (1.10%)  1
Anemias  2/91 (2.20%)  2
Anemias Caused By Blood Loss  2/91 (2.20%)  2
Anemias Caused By Deficient Erythropoiesis  1/91 (1.10%)  1
Anesthesia Reaction  1/91 (1.10%)  1
Arrhythmias  2/91 (2.20%)  2
Arterial Pulse Loss  2/91 (2.20%)  2
Asthma  4/91 (4.40%)  4
Atelectasis  8/91 (8.79%)  8
Atopic Dermatitis  1/91 (1.10%)  1
Atrial Fibrillation  1/91 (1.10%)  1
Atrial Flutter  1/91 (1.10%)  1
Bacteremia  4/91 (4.40%)  4
Bacterial Infections  4/91 (4.40%)  6
Biventricular Hypertrophy/Combined Ventricular Hypertrophy  1/91 (1.10%)  1
Blood Loss  5/91 (5.49%)  5
Blood Transfusion  6/91 (6.59%)  6
Bradycardia  4/91 (4.40%)  4
Broad QRS Complex Arrhythmias  1/91 (1.10%)  1
Bronchomalacia  1/91 (1.10%)  1
Bruise/Purpura Simplex  1/91 (1.10%)  1
CVVH (Continuous Veno Venous Hemofiltration)  1/91 (1.10%)  1
Cardiac Arrest  2/91 (2.20%)  2
Cardiac Perforation  2/91 (2.20%)  2
Cardiac Cath  1/91 (1.10%)  1
Cardiac Surgery  13/91 (14.29%)  14
Cardiomyopathy  3/91 (3.30%)  3
Cellulitis  1/91 (1.10%)  1
Chest Pain  4/91 (4.40%)  5
Cholecystitis  1/91 (1.10%)  1
Chronic Recurrent Drainage/Oozing  1/91 (1.10%)  1
Circumcision  1/91 (1.10%)  1
Coarctation of Aorta  1/91 (1.10%)  1
Cobra Formation  1/91 (1.10%)  1
Common Cold/Upper Respiratory Tract Infection  9/91 (9.89%)  16
Congestive Heart Failure  2/91 (2.20%)  2
Conjunctivitis  1/91 (1.10%)  1
Cough  2/91 (2.20%)  2
Croup  2/91 (2.20%)  2
Cyanosis  1/91 (1.10%)  1
Death*  4/91 (4.40%)  4
Dehydration  2/91 (2.20%)  2
Delivery System Failure  4/91 (4.40%)  4
Device Collapse  1/91 (1.10%)  1
Device Embolization  2/91 (2.20%)  2
Diabetes Mellitus  1/91 (1.10%)  1
Dizziness  3/91 (3.30%)  3
Dual Pacemaker  2/91 (2.20%)  3
Dyspnea  4/91 (4.40%)  4
Edema  3/91 (3.30%)  3
Elective Surgery  2/91 (2.20%)  3
Elective Adenoidectomy with Tympanostomy Tubes  1/91 (1.10%)  1
Encephalopathy  1/91 (1.10%)  1
Fever  4/91 (4.40%)  7
First Degree Heart/AV Block/Cardiac Arrhythmia – 1st Degree AV Block  1/91 (1.10%)  1
Foreign Bodies  2/91 (2.20%)  2
Fracture  1/91 (1.10%)  1
Functional Vomiting  1/91 (1.10%)  1
Fungal Pneumonia  1/91 (1.10%)  1
Gastroesophageal Reflux Disease  4/91 (4.40%)  4
Gastrointestinal Bleeding  1/91 (1.10%)  1
Gastrostomy Tube  1/91 (1.10%)  1
Headache  3/91 (3.30%)  3
Hematoma  4/91 (4.40%)  4
Hematoma of the Groin  2/91 (2.20%)  2
Hematuria  1/91 (1.10%)  1
Hemostasis and Coagulation Disorders  2/91 (2.20%)  2
Hyperglycemia  1/91 (1.10%)  1
Hypotension  10/91 (10.99%)  10
Incomplete Right Bundle Branch Block  2/91 (2.20%)  2
Ingestion  1/91 (1.10%)  1
Interventricular Conduction Delay  1/91 (1.10%)  1
Junctional Escape Beat  1/91 (1.10%)  1
Junctional Escape Rhythm/Intermittent Junctional Rhythm  2/91 (2.20%)  2
Lacerations  1/91 (1.10%)  2
Left Ventricular Hypertrophy  1/91 (1.10%)  1
Liver Enlargement  1/91 (1.10%)  1
Meatal Stenosis  1/91 (1.10%)  1
Memory Loss  1/91 (1.10%)  1
Metabolic Alkalosis  1/91 (1.10%)  1
Migraine  1/91 (1.10%)  1
Mild Mitral Valve Regurgitation  1/91 (1.10%)  1
Mild Tricuspid Regurgitation  3/91 (3.30%)  3
Miscellaneous Infections  2/91 (2.20%)  2
Mitral Valve Regurgitation/Mitral Insufficiency  1/91 (1.10%)  1
Mobitz II Block  5/91 (5.49%)  5
Moderate Tricuspid Regurgitation  1/91 (1.10%)  1
Musculoskeletal Pain  1/91 (1.10%)  1
Myalgias  1/91 (1.10%)  1
Nausea  2/91 (2.20%)  2
Nonspecific Intraventricular Conduction Defects  3/91 (3.30%)  3
Nose Bleed  1/91 (1.10%)  1
Other  1/91 (1.10%)  1
Otitis Media  1/91 (1.10%)  1
Pallor  1/91 (1.10%)  1
Palpitations  2/91 (2.20%)  2
Paroxysmal Junctional Tachycardia  1/91 (1.10%)  1
Paroxysmal Ventricular Tachycardia  3/91 (3.30%)  3
Pericardial Effusion  4/91 (4.40%)  5
Pharyngitis  2/91 (2.20%)  2
Pleural Effusions  3/91 (3.30%)  3
Pleuropericardial Fluid  1/91 (1.10%)  1
Pneumonia  4/91 (4.40%)  6
Pneumonia Caused By Gram-Negative Bacilli  1/91 (1.10%)  1
Pneumothorax  1/91 (1.10%)  1
Poor Device Position  1/91 (1.10%)  1
Premature Atrial Beat  1/91 (1.10%)  1
Premature Ventricular Contraction  2/91 (2.20%)  2
Pulmonary Congestion  1/91 (1.10%)  1
Pulmonary Hemorrhage  1/91 (1.10%)  1
Pulmonary Hypertension  1/91 (1.10%)  1
Pulmonary Stenosis  1/91 (1.10%)  1
Pulmonary Edema  6/91 (6.59%)  7
Rash  3/91 (3.30%)  3
Renal Failure  1/91 (1.10%)  1
Respiratory Synctial Virus Infection (RSV)  3/91 (3.30%)  3
Right Bundle Branch Block/Complete Right Bundle Branch Block  11/91 (12.09%)  13
Right Ventricular Hypertrophy  1/91 (1.10%)  1
Scoliosis  1/91 (1.10%)  1
Seizure/Convulsions/Epilepsy  1/91 (1.10%)  1
Seizures  3/91 (3.30%)  3
Sinusitis  5/91 (5.49%)  6
Stridor  1/91 (1.10%)  1
Stroke  2/91 (2.20%)  2
Subaortic Stenosis  2/91 (2.20%)  4
Subglottic Edema 2 to Prolonged Intubation  1/91 (1.10%)  1
Syncope  1/91 (1.10%)  1
Tachypnea  1/91 (1.10%)  1
Third Degree Heart Block (Complete Heart Block)  5/91 (5.49%)  6
Trace Tricuspid Regurgitation (Tricuspid Incompetence or Ins)  1/91 (1.10%)  1
Tracheostomy  2/91 (2.20%)  2
Trigeminy  1/91 (1.10%)  1
Urinary Tract Infections  1/91 (1.10%)  1
Vascular Congestion  1/91 (1.10%)  1
Venous Thrombosis  1/91 (1.10%)  1
Ventricular Escape Rhythm  1/91 (1.10%)  1
Viral Gastroenteritis  3/91 (3.30%)  4
Viral Pneumonia  1/91 (1.10%)  1
Vocal Cord Paralysis  1/91 (1.10%)  1
Vomiting  4/91 (4.40%)  5
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maren Wagner
Organization: Abbott
Phone: 6517565585
EMail: maren.wagner@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00583791    
Other Study ID Numbers: AGA-005
G990289
First Submitted: December 20, 2007
First Posted: December 31, 2007
Results First Submitted: December 20, 2013
Results First Posted: June 28, 2019
Last Update Posted: June 28, 2019