Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 18 for:    citadel

TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD (Centurion)

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: NCT01043705
Recruitment Status : Completed
First Posted : January 7, 2010
Results First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
TYRX, Inc.

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition Cardiac Implantable Electronic Device Infection
Enrollment 1262
Recruitment Details First Patient Enrolled = 1 January 2010; Last Patient Enrolled = 7 May 2013
Pre-assignment Details CRT and ICD Implant patients with TYRX Implant; Full analysis cohort = 1,129 patients. 670 patient CRT + TYRX cohort is subset. 459 patient ICD + TYRX is subset. 578 CRT+ TYRX patient cohort is subset matched to 578 patient CRT/no TYRX retrospective patient arm.
Arm/Group Title ICD With TYRX Implant CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants CRT With no TYRX Retrospective Case Control
Hide Arm/Group Description All patients receiving a TYRX envelope who were eligible to participate having a replacement ICD implant Patients receiving a TYRX envelope who were eligible to participate having a replacement CRT implant who have a valid non-TYRX implant case-match Retrospective site matched and case-matched CRT replacement patients who did not receive a TYRX envelope selected in the era just prior to availability of TYRX Envelope
Period Title: Overall Study
Started 459 578 578
Completed 352 447 498
Not Completed 107 131 80
Reason Not Completed
Death             28             60             26
Lost to Follow-up             27             12             0
Multiple Reasons             4             7             0
Protocol Violation             2             1             0
Withdrawal by Subject             8             6             0
Site Closure             8             0             0
Subsequent Procedure             9             24             29
Adverse Event             0             2             0
Screen Fail             21             0             0
Other             0             19             25
Arm/Group Title CIED Replacement With ICD and TYRX CIED Replacement With CRT and no TYRX CIED Replacement With CRT and TYRX Vs. Case Match Arm Total
Hide Arm/Group Description (Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision. (Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition. Prospective CRT patients who received a TYRX envelope and had a valid case match retrospective patient. This is a subset of all CRT/TYRX patients Total of all reporting groups
Overall Number of Baseline Participants 459 578 578 1615
Hide Baseline Analysis Population Description
Prospective Population: ICD and CRT replacement implant patients receiving a TYRX Envelope Retrospective Population: CRT Patients receiving a CRT and no TYRX envelope. Patients are site medical charts from just previous to use of TYRX Evelope
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 459 participants 578 participants 578 participants 1615 participants
70  (12.01) 73  (10.94) 73  (10.70) 72  (11.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 459 participants 578 participants 578 participants 1615 participants
Female
339
  73.9%
434
  75.1%
444
  76.8%
1217
  75.4%
Male
120
  26.1%
144
  24.9%
134
  23.2%
398
  24.6%
1.Primary Outcome
Title Major CIED Infection
Hide Description CIED Major Infections
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients that have valid entry criteria
Arm/Group Title CIED Replacement With CRT and TYRX CIED Replacement With CRT and no TYRX CIED Replacement With CRT and TYRX vs. Case Match Arm
Hide Arm/Group Description:
(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
Overall Number of Participants Analyzed 670 578 578
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Participants
0.6
(0 to 1.4)
1.0
(0 to 2.0)
0.7
(0 to 1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CIED Replacement With CRT and TYRX, CIED Replacement With CRT and no TYRX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter One sided Fisher's exact test.
Estimated Value 0.0044
Confidence Interval (1-Sided) 95%
0.009
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CIED Replacement With CRT and TYRX, CIED Replacement With CRT and no TYRX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-sided Fisher's Exact Text
Estimated Value 0.002
Confidence Interval (1-Sided) 95%
0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CIED Replacement With CRT and TYRX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0176
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-sided Fisher's Exact Test
Estimated Value 0.006
Confidence Interval (1-Sided) 95%
0.014
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CIED Replacement With CRT and no TYRX, CIED Replacement With CRT and TYRX vs. Case Match Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3764
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's Exact Test
Estimated Value .7
Estimation Comments [Not Specified]
2.Primary Outcome
Title CIED Mechanical Complication
Hide Description All mechanical Complications related to CIED Implant
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
TYRX implants vs. published comparator are "prospective arm" patients. Non-TYRX CIED retrospective arm vs. TYRX CIED replacements are nested, case-control cohort.
Arm/Group Title CIED Replacement With ICD and TYRX CIED Replacement With CRT and no TYRX CIED Replacement With CRT and TYRX vs. Case Match Arm
Hide Arm/Group Description:
(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
Overall Number of Participants Analyzed 459 578 578
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Participants
3.1
(1.7 to 5.1)
5.5
(3.8 to 7.7)
5.4
(3.7 to 7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CIED Replacement With ICD and TYRX, CIED Replacement With CRT and no TYRX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method 1-sided Chi-square
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate compared to performance goal
Estimated Value 4.4
Confidence Interval (2-Sided) 95%
3.3 to 5.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CIED Replacement With ICD and TYRX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0444
Comments [Not Specified]
Method 1-sided Chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate compared to a performance goal
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
1.7 to 5.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CIED Replacement With ICD and TYRX, CIED Replacement With CRT and no TYRX
Comments All types of mechanical complications combined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method 1-sided Chi-squared test
Comments [Not Specified]
Method of Estimation Estimation Parameter rate compared to performance goal
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
3.8 to 5.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CIED Replacement With CRT and no TYRX, CIED Replacement With CRT and TYRX vs. Case Match Arm
Comments All mechanical complications, retrospective, non-TYRX cohort
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0745
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Descriptive
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
3.7 to 7.5
Estimation Comments [Not Specified]
Time Frame During 12 month follow up period
Adverse Event Reporting Description

Note that non-serious adverse events were not collected or assessed as part of this study.

Adverse events coded as "death" do not have further description.

 
Arm/Group Title CIED Replacement With CRT and TYRX CIED Replacement With ICD and TYRX
Hide Arm/Group Description (Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision. (Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
All-Cause Mortality
CIED Replacement With CRT and TYRX CIED Replacement With ICD and TYRX
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CIED Replacement With CRT and TYRX CIED Replacement With ICD and TYRX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   96/578 (16.61%)      46/459 (10.02%)    
Blood and lymphatic system disorders     
Anaemia * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Leukocytosis * 1  2/578 (0.35%)  2 1/459 (0.22%)  1
Cardiac disorders     
Acute Myocardial Infarction * 1  2/578 (0.35%)  2 1/459 (0.22%)  1
Aortic Valve Stenosis * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Atrial Fibrillation * 1  2/578 (0.35%)  2 1/459 (0.22%)  1
Atrial Thrombosis * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Cardiac Amyloidosis * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Cardiac Arrest * 1  5/578 (0.87%)  5 2/459 (0.44%)  2
Cardiac disorder * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Cardiac Failure * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Cardiac Failure Acute * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Cardiac Failure Congestive * 1  18/578 (3.11%)  18 6/459 (1.31%)  6
Cardio-respiratory failure * 1  4/578 (0.69%)  4 1/459 (0.22%)  1
Cardiogenic Shock * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Cardiomyopathy * 1  2/578 (0.35%)  2 1/459 (0.22%)  1
Cardiopulmonary Failure * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Coronary Artery Disease * 1  3/578 (0.52%)  3 0/459 (0.00%)  0
Ischemic Cardiomyopathy * 1  3/578 (0.52%)  3 0/459 (0.00%)  0
Low Cardiac Output Syndrome * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Mitral Valve Incompetence * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Myocardial Infarction * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Palpitations * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Restrictive Cardiomyopathy * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Tricuspid Valve Incompetence * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Ventricular Tachycardia * 1  0/578 (0.00%)  0 2/459 (0.44%)  2
Endocrine disorders     
Hypothyroidism * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal Heamorrhage * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Gastrooesophageal Reflux Disease * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Lower Gastrointestinal Haemorrhage * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Rectal Haemorrhage * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
General disorders     
Adverse Drug Reaction * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Asthenia * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Brain Death * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Chest Pain * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Chills * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Complication of Device Removal * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Condition Aggravated * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Death * 1  45/578 (7.79%)  45 24/459 (5.23%)  24
Device Component Issue * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Device dislocation * 1  4/578 (0.69%)  4 1/459 (0.22%)  1
Device Electrical Finding * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Device Failure * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Device Lead Damage * 1  2/578 (0.35%)  2 1/459 (0.22%)  1
Device Lead Issue * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Device Malfunction * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Device Pacing Issue * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Device Stimulation Issue * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Feeling Hot * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
General Physical Health Deterioration * 1  4/578 (0.69%)  4 1/459 (0.22%)  1
Impaired Healing * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Implant Site Discharge * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Implant Site Haematoma * 1  6/578 (1.04%)  6 0/459 (0.00%)  0
Implant Site Haemorrhage * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Implant Site Pain * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Medical Device Site Reaction * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Multi-Organ Failure * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Multimorbidity * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Oedema Peripheral * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Pyrexia * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Treatment Failure * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Infections and infestations     
Cardiac Valve Vegetation * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Device Related Infection * 1  2/578 (0.35%)  2 1/459 (0.22%)  1
Endocarditis * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Implant Site Cellulitis * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Implant Site Infection * 1  2/578 (0.35%)  2 3/459 (0.65%)  3
Infected Skin Ulcer * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Infection * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Klebsiella Sepsis * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Pneumonia * 1  7/578 (1.21%)  7 2/459 (0.44%)  2
Pneumonia Staphylococcal * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Sepsis * 1  1/578 (0.17%)  1 2/459 (0.44%)  2
Septic Shock * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Staphylococcal Bacteraemia * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Streptococcal Sepsis * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Urinary Tract Infection * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Urosepsis * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Injury, poisoning and procedural complications     
Eschar * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Fall * 1  3/578 (0.52%)  3 1/459 (0.22%)  1
Fibula Fracture * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Incision Site Haematoma * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Post Procedural Discharge * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Seroma * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Tibia Fracture * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Wound Dehiscence * 1  2/578 (0.35%)  2 1/459 (0.22%)  1
Investigations     
Blood Creatinine Increased * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Blood Culture Positive * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Blood Urea Increased * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Blood Urea Nitrogen/Creatinine Ratio Increased * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
International Normalised Ratio Increased * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Troponin Increased * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Metabolism and nutrition disorders     
Dehydration * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Diabetes Mellitus * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Failure to Thrive * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Hyponatraemia * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Hypovolaemia * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/578 (0.35%)  2 1/459 (0.22%)  1
Pain in Extremity * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hodgin's Disease * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Lung Neoplasm Malignant * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Lymphoma * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Neoplasm Malignant * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Non-Small Cell Lung Cancer Recurrent * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Oesophageal Carcinoma * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Nervous system disorders     
Convulsion * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Dementia * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Ischaemic Stroke * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Lethargy * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Loss of Consciousness * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Presyncope * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Syncope * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Psychiatric disorders     
Anxiety * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Confusional State * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Renal and urinary disorders     
Renal Failure * 1  2/578 (0.35%)  2 2/459 (0.44%)  2
Renal Failure Acute * 1  4/578 (0.69%)  4 0/459 (0.00%)  0
Renal Failure Chronic * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Renal Mass * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Chronic Obstructive Pulmonary Disease * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Cough * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Dyspnoea * 1  9/578 (1.56%)  9 4/459 (0.87%)  4
Hypoxia * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Lung Consolidation * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Long Disorder * 1  2/578 (0.35%)  2 0/459 (0.00%)  0
Orthopnoea * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Pleural Effusion * 1  3/578 (0.52%)  3 0/459 (0.00%)  0
Productive Cough * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Pulmonary Embolism * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Pulmonary Mass * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Pulmonary Oedema * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Respiratory Failure * 1  2/578 (0.35%)  2 1/459 (0.22%)  1
Skin and subcutaneous tissue disorders     
Hyperhidrosis * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Rash * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Skin Erosion * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Surgical and medical procedures     
Aortic Valve Replacement * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Cardiac Pacemaker Removal * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Cardiac Pacemaker Replacement * 1  3/578 (0.52%)  3 1/459 (0.22%)  1
Cardio Pacemaker Revision * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Cardioversion * 1  2/578 (0.35%)  2 1/459 (0.22%)  1
Chest Tube Insertion * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Drain Placement * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Emergency Care * 1  5/578 (0.87%)  5 1/459 (0.22%)  1
Endotracheal Intubation * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Haemodialysis * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Hospice Care * 1  4/578 (0.69%)  4 0/459 (0.00%)  0
Hospitalisation * 1  27/578 (4.67%)  27 10/459 (2.18%)  10
Implantable Defibrillator Insertion * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Incisional Drainage * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Mechanical Ventilation * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Medical Device Change * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Medical Device Removal * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Packed Red Blood Cell Transfusion * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Palliative Care * 1  2/578 (0.35%)  2 3/459 (0.65%)  3
Rehabilitation Therapy * 1  1/578 (0.17%)  1 1/459 (0.22%)  1
Tracheostomy * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Ventricular Assist Device Insertion * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Withdrawal of Life Support * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Wound Drainage * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Vascular disorders     
Distributive Shock * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
Haematoma * 1  0/578 (0.00%)  0 1/459 (0.22%)  1
Hypotension * 1  3/578 (0.52%)  3 0/459 (0.00%)  0
Peripheral Arterial Occlusive Disease * 1  1/578 (0.17%)  1 0/459 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CIED Replacement With CRT and TYRX CIED Replacement With ICD and TYRX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
This was a non-randomized study and did not have an active comparator.
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: Lynn Landborg, Clinical Research Manager
Organization: Medtronic plc
Phone: 763 526 2877
EMail: lynn.landborg@medtronic.com
Layout table for additonal information
Responsible Party: TYRX, Inc.
ClinicalTrials.gov Identifier: NCT01043705     History of Changes
Obsolete Identifiers: NCT01043861
Other Study ID Numbers: CP-2009-2
First Submitted: January 5, 2010
First Posted: January 7, 2010
Results First Submitted: October 13, 2015
Results First Posted: December 24, 2015
Last Update Posted: December 24, 2015