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Shockless Implant Evaluation (SIMPLE)

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: NCT00800384
Recruitment Status : Completed
First Posted : December 2, 2008
Results First Posted : December 22, 2015
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Guidant Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Conditions Ventricular Fibrillation
Ventricular Tachycardia
Intervention Device: Implantable defibrillator
Enrollment 2500
Recruitment Details First patient was recruited 13 January 2014, last patient was recruited 4 April 2011. All patients were part of the general ICD population at participating sites.
Pre-assignment Details  
Arm/Group Title ICD Implant Without Defibrillation Testing ICD Implant With Defibrillation Testing
Hide Arm/Group Description Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed. Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
Period Title: Overall Study
Started 1247 1253
Completed 1206 1210
Not Completed 41 43
Reason Not Completed
Withdrawal by Subject             24             17
Lost to Follow-up             17             26
Arm/Group Title ICD Implant Without Defibrillation Testing ICD Implant With Defibrillation Testing Total
Hide Arm/Group Description Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed. Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant. Total of all reporting groups
Overall Number of Baseline Participants 1247 1253 2500
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1247 participants 1253 participants 2500 participants
62.58  (11.51) 62.98  (11.69) 62.78  (11.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1247 participants 1253 participants 2500 participants
Female
232
  18.6%
244
  19.5%
476
  19.0%
Male
1015
  81.4%
1009
  80.5%
2024
  81.0%
1.Primary Outcome
Title First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
Hide Description The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.
Time Frame Mean follow-up of 3.1 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were analyzed as per intention to treat. An on treatment analysis was performed in 1190 patients in the group without defibrillation testing and in 1165 patients in the group with defibrillation testing.
Arm/Group Title ICD Implant Without Defibrillation Testing ICD Implant With Defibrillation Testing
Hide Arm/Group Description:
Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
Overall Number of Participants Analyzed 1247 1253
Measure Type: Number
Unit of Measure: participants
90 104
2.Secondary Outcome
Title Perioperative Complication Rate
Hide Description A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Perioperative complication rate was assessed in patients undergoing ICD implant. Number of patients having experienced at least one of the predefined complications was assessed.
Arm/Group Title ICD Implant Without Defibrillation Testing ICD Implant With Defibrillation Testing
Hide Arm/Group Description:
Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
Patients in this arm were implanted with their ICD and ventricular fibrillation (VF) induction was performed followed by shock delivery to test shock efficacy at implant.
Overall Number of Participants Analyzed 1236 1242
Measure Type: Number
Unit of Measure: participants
69 81
Time Frame Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
Adverse Event Reporting Description All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
 
Arm/Group Title ICD Implant Without Defibrillation Testing ICD Implant With Defibrillation Testing
Hide Arm/Group Description Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed. Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
All-Cause Mortality
ICD Implant Without Defibrillation Testing ICD Implant With Defibrillation Testing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ICD Implant Without Defibrillation Testing ICD Implant With Defibrillation Testing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   776/1247 (62.23%)      790/1253 (63.05%)    
Blood and lymphatic system disorders     
Abnormal laboratory values  1  8/1247 (0.64%)  8 8/1253 (0.64%)  8
Hematological  1  19/1247 (1.52%)  24 15/1253 (1.20%)  17
Cardiac disorders     
PG System  1  2/1247 (0.16%)  2 1/1253 (0.08%)  1
Unable to capture - RV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Unable to convert - Defibrillation  1  2/1247 (0.16%)  2 10/1253 (0.80%)  11
Elevated DFT - Defibrillation  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
PG system - Therapy  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Inappropriate tachy therapy - SVT  1  25/1247 (2.00%)  27 25/1253 (2.00%)  30
Inappropriate tachy therapy - NSR  1  2/1247 (0.16%)  2 3/1253 (0.24%)  3
Inappropriate tachy therapy - Noise  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
Inappropriate tachy therapy - Other  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
Early ERI - Random component failure  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
Early ERI - Consistent with device programming  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Early ERI - Premature declaration  1  3/1247 (0.24%)  3 4/1253 (0.32%)  4
Pacemaker-mediated tachycardia  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
PG System - Patient related  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Undersensing - RA  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Unable to capture - RA  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
Elevated threshold - RA  1  1/1247 (0.08%)  1 2/1253 (0.16%)  2
Conductor coil fracture - RA  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Dislodgment - Unable to capture – RA  1  0/1247 (0.00%)  0 3/1253 (0.24%)  4
Dislodgment - Extracardiac stimulation- RA  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Dislodgment - Multiple signs - RA  1  4/1247 (0.32%)  4 1/1253 (0.08%)  1
Dislodgment - No reported signs - RA  1  8/1247 (0.64%)  8 8/1253 (0.64%)  9
Other - Lead  1  2/1247 (0.16%)  2 3/1253 (0.24%)  3
RV - unspecific  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Oversensing - RV  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
Unable to capture - RV  1  7/1247 (0.56%)  7 1/1253 (0.08%)  1
Elevated threshold - RV  1  7/1247 (0.56%)  7 6/1253 (0.48%)  6
Conductor coil fracture - RV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Insulation breach - RV  1  0/1247 (0.00%)  0 4/1253 (0.32%)  4
Electrode damaged - RV  1  2/1247 (0.16%)  2 1/1253 (0.08%)  1
Myocardial perforation post- implant - RV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Impedance < 300 ohms - RV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Impedance > 2000 ohms - RV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Dislodgment - Unable to capture RV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Dislodgment - Elevated threshold -RV  1  7/1247 (0.56%)  7 2/1253 (0.16%)  2
Dislodgment - Oversensing - RV  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Dislodgment - Multiple signs - RV  1  3/1247 (0.24%)  3 3/1253 (0.24%)  3
Dislodgment - No reported signs - RV  1  7/1247 (0.56%)  7 8/1253 (0.64%)  9
Unable to capture - LV  1  2/1247 (0.16%)  2 3/1253 (0.24%)  3
Elevated threshold - LV  1  2/1247 (0.16%)  2 1/1253 (0.08%)  1
Extracardiac stimulation - LV  1  4/1247 (0.32%)  4 4/1253 (0.32%)  4
Electrode damaged - LV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Dislodgment - Unable to capture - LV  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Dislodgment - Elevated threshold - LV  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Dislodgment - Extracardiac stimulation- LV  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
Dislodgment - Multiple signs - LV  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Dislodgment - No reported signs -LV  1  5/1247 (0.40%)  6 4/1253 (0.32%)  4
Oversensing - Defibrillation lead  1  2/1247 (0.16%)  2 3/1253 (0.24%)  3
Undersensing - Defibrillation lead  1  3/1247 (0.24%)  3 3/1253 (0.24%)  3
Elevated DFT - Defibrillation lead  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Patient CONDITION Cardiovascular  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Tachycardia - unspecific  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Bradyarrhythmias - unspecific  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
1st degree AV block  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
3rd degree AV block  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
Sinus bradycardia  1  1/1247 (0.08%)  1 3/1253 (0.24%)  3
Pulseless electrical activity (PEA)  1  2/1247 (0.16%)  2 5/1253 (0.40%)  5
Ventricular tachyarrhythmias - unspecified  1  6/1247 (0.48%)  6 7/1253 (0.56%)  8
Ventricular fibrillation (VF)  1  13/1247 (1.04%)  13 7/1253 (0.56%)  8
Ventricular tachycardia (VT)  1  49/1247 (3.93%)  65 38/1253 (3.03%)  57
Electrical Storm  1  15/1247 (1.20%)  15 13/1253 (1.04%)  15
Nonsustained ventricular tachycardia (NSVT)  1  5/1247 (0.40%)  5 2/1253 (0.16%)  2
Ventricular flutter  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Atrial Tachyarrhythmias - unspecific  1  6/1247 (0.48%)  6 2/1253 (0.16%)  2
Atrial fibrillation (AF)  1  42/1247 (3.37%)  48 49/1253 (3.91%)  65
Atrial flutter  1  13/1247 (1.04%)  17 17/1253 (1.36%)  17
Other SVT (eg AVRT, AVNRT, EAT)  1  2/1247 (0.16%)  2 7/1253 (0.56%)  8
Atypical Atrial Flutter  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Premature ventricular contractions (PVC)  1  2/1247 (0.16%)  2 4/1253 (0.32%)  4
Syncope - Heart failure  1  3/1247 (0.24%)  3 0/1253 (0.00%)  0
Dizziness - Heart failure  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Chest pain - Heart failure  1  6/1247 (0.48%)  7 2/1253 (0.16%)  2
Dyspnea - Heart failure  1  42/1247 (3.37%)  50 41/1253 (3.27%)  50
Peripheral edema - Heart failure  1  7/1247 (0.56%)  12 5/1253 (0.40%)  5
Fatigue - Heart failure  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Dehydration - Heart failure  1  4/1247 (0.32%)  4 4/1253 (0.32%)  4
Heart failure symptoms - Unspecified  1  37/1247 (2.97%)  45 42/1253 (3.35%)  62
Multiple heart failure symptoms  1  145/1247 (11.63%)  212 138/1253 (11.01%)  202
Hypertension - Heart failure  1  2/1247 (0.16%)  2 1/1253 (0.08%)  1
Other- Heart failure patient condition – Cardiovascular  1  7/1247 (0.56%)  7 3/1253 (0.24%)  3
Multi-system failure - Heart failure  1  76/1247 (6.09%)  81 57/1253 (4.55%)  63
Cardiogenic shock  1  5/1247 (0.40%)  5 9/1253 (0.72%)  9
Cardiac arrest  1  7/1247 (0.56%)  7 11/1253 (0.88%)  11
Myocardial infarction  1  34/1247 (2.73%)  34 27/1253 (2.15%)  29
Valve related - unspecific  1  13/1247 (1.04%)  13 13/1253 (1.04%)  15
Mitral stenosis  1  1/1247 (0.08%)  1 1/1253 (0.08%)  2
Mitral regurgitation  1  3/1247 (0.24%)  3 2/1253 (0.16%)  2
Chest pain – Ischemic  1  20/1247 (1.60%)  25 21/1253 (1.68%)  24
Endocrine disorders     
Endocrine  1  25/1247 (2.00%)  28 32/1253 (2.55%)  35
Gastrointestinal disorders     
Gastrointestinal - Heart failure  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Gastrointestinal  1  95/1247 (7.62%)  132 115/1253 (9.18%)  147
General disorders     
Syncope  1  26/1247 (2.09%)  28 37/1253 (2.95%)  41
Dizziness  1  8/1247 (0.64%)  8 2/1253 (0.16%)  2
Chest pain – Other  1  22/1247 (1.76%)  23 19/1253 (1.52%)  22
Dyspnea  1  9/1247 (0.72%)  9 9/1253 (0.72%)  9
Palpitations  1  0/1247 (0.00%)  0 3/1253 (0.24%)  3
Fatigue  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
Other- Patient condition – Cardiovascular  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
WHOLE BODY  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Death - Reason unspecified  1  46/1247 (3.69%)  46 50/1253 (3.99%)  50
Fever  1  9/1247 (0.72%)  10 3/1253 (0.24%)  3
Physical trauma  1  29/1247 (2.33%)  32 37/1253 (2.95%)  42
Head, eyes, ears, nose, throat (HEENT)  1  31/1247 (2.49%)  39 23/1253 (1.84%)  25
Multi-system failure  1  7/1247 (0.56%)  7 12/1253 (0.96%)  12
  1  13/1247 (1.04%)  14 14/1253 (1.12%)  15
Adverse drug reaction  1  14/1247 (1.12%)  14 13/1253 (1.04%)  13
  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Immune system disorders     
Adverse reaction – Allergic reaction  1  3/1247 (0.24%)  3 2/1253 (0.16%)  2
Immune  1  3/1247 (0.24%)  3 3/1253 (0.24%)  3
Infections and infestations     
PG system - Infection (> 30 days post implant)  1  24/1247 (1.92%)  29 21/1253 (1.68%)  23
Seroma - Pocket (> 30 days post- implant)  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Post-surgical infection (<= 30 days post-implant)  1  11/1247 (0.88%)  13 10/1253 (0.80%)  10
Systemic infection  1  46/1247 (3.69%)  52 36/1253 (2.87%)  40
Musculoskeletal and connective tissue disorders     
Musculoskeletal  1  41/1247 (3.29%)  46 34/1253 (2.71%)  38
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer  1  61/1247 (4.89%)  81 60/1253 (4.79%)  91
Nervous system disorders     
Neurological  1  15/1247 (1.20%)  17 18/1253 (1.44%)  20
Psychiatric disorders     
Psychological effect due to device therapy  1  2/1247 (0.16%)  2 1/1253 (0.08%)  1
Psychological  1  11/1247 (0.88%)  12 14/1253 (1.12%)  17
Renal and urinary disorders     
Renal insufficiency - Heart failure  1  9/1247 (0.72%)  12 4/1253 (0.32%)  6
Genitourinary  1  26/1247 (2.09%)  33 38/1253 (3.03%)  46
Renal  1  54/1247 (4.33%)  61 41/1253 (3.27%)  52
Respiratory, thoracic and mediastinal disorders     
Pulmonary edema - Heart failure  1  23/1247 (1.84%)  26 12/1253 (0.96%)  14
COPD exacerbation  1  24/1247 (1.92%)  37 15/1253 (1.20%)  25
Pulmonary  1  94/1247 (7.54%)  123 95/1253 (7.58%)  115
Skin and subcutaneous tissue disorders     
Erosion  1  5/1247 (0.40%)  5 6/1253 (0.48%)  7
Migration  1  0/1247 (0.00%)  0 3/1253 (0.24%)  3
Integumentary  1  20/1247 (1.60%)  23 10/1253 (0.80%)  10
Surgical and medical procedures     
Post-surgical wound discomfort  1  7/1247 (0.56%)  7 2/1253 (0.16%)  2
Post-surgical pocket hemorrhage  1  0/1247 (0.00%)  0 4/1253 (0.32%)  4
Adverse reaction - General  1  2/1247 (0.16%)  2 5/1253 (0.40%)  5
Adverse reaction - Respiratory  1  0/1247 (0.00%)  0 6/1253 (0.48%)  6
Adverse reaction - Hypotension  1  1/1247 (0.08%)  1 2/1253 (0.16%)  2
Hemodynamic instability - DFT testing  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Inadvertent VT/VF  1  1/1247 (0.08%)  1 5/1253 (0.40%)  5
Inadvertent SVT  1  2/1247 (0.16%)  2 3/1253 (0.24%)  3
Chest pain  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Hemorrhage  1  2/1247 (0.16%)  2 5/1253 (0.40%)  5
Physical trauma  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
Hematoma - Pocket (<=30 days post-implant)  1  23/1247 (1.84%)  24 31/1253 (2.47%)  31
Seroma - Pocket (<=30 days post-implant)  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Thromboembolic events  1  6/1247 (0.48%)  7 10/1253 (0.80%)  10
Other - PG system – Procedure  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
Puncture site hematoma - Procedure  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Pneumothorax - Procedure  1  19/1247 (1.52%)  20 11/1253 (0.88%)  11
Renal failure due to contrast media – Procedure  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Pleural effusion - Procedure  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Hemothorax - Procedure  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Coronary venous dissection  1  1/1247 (0.08%)  1 3/1253 (0.24%)  3
Myocardial perforation with tamponade  1  1/1247 (0.08%)  1 2/1253 (0.16%)  2
AV block (transient) - Procedure  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Pericardial effusion  1  7/1247 (0.56%)  8 3/1253 (0.24%)  3
Other - Lead – Procedure  1  18/1247 (1.44%)  18 18/1253 (1.44%)  18
Procedure related complication other than implant procedure  1  16/1247 (1.28%)  21 12/1253 (0.96%)  12
Pericardial effusion - Unrelated to procedure  1  2/1247 (0.16%)  2 5/1253 (0.40%)  5
Pericarditis  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Hematoma  1  9/1247 (0.72%)  9 5/1253 (0.40%)  5
Hemorrhage  1  6/1247 (0.48%)  7 5/1253 (0.40%)  6
Vascular disorders     
Hypotension  1  9/1247 (0.72%)  9 10/1253 (0.80%)  11
Hypertension  1  3/1247 (0.24%)  3 3/1253 (0.24%)  3
Coronary Artery Disease  1  83/1247 (6.66%)  103 46/1253 (3.67%)  63
Vascular disease - unspecific  1  5/1247 (0.40%)  5 6/1253 (0.48%)  8
Peripheral vascular disease  1  36/1247 (2.89%)  55 37/1253 (2.95%)  62
Aortic stenosis  1  2/1247 (0.16%)  2 4/1253 (0.32%)  4
Thromboembolic events - unspecific  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Transient ischemic attack (TIA)  1  9/1247 (0.72%)  9 12/1253 (0.96%)  12
Cerebrovascular accident (CVA)  1  33/1247 (2.65%)  34 23/1253 (1.84%)  26
Deep vein thrombosis (DVT)  1  2/1247 (0.16%)  2 1/1253 (0.08%)  1
Pulmonary embolism (PE)  1  6/1247 (0.48%)  6 6/1253 (0.48%)  6
Distal thromboemboli  1  8/1247 (0.64%)  8 8/1253 (0.64%)  10
Intracardiac thrombus  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Vasovagal reaction  1  3/1247 (0.24%)  3 2/1253 (0.16%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, BSC coding list
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ICD Implant Without Defibrillation Testing ICD Implant With Defibrillation Testing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   625/1247 (50.12%)      632/1253 (50.44%)    
Blood and lymphatic system disorders     
Abnormal laboratory values  1  14/1247 (1.12%)  15 5/1253 (0.40%)  5
Hematological  1  18/1247 (1.44%)  20 12/1253 (0.96%)  14
Cardiac disorders     
PG System  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Oversensing - RA  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Other - PG system  1  3/1247 (0.24%)  3 0/1253 (0.00%)  0
Unable to convert - Defibrillation  1  1/1247 (0.08%)  1 2/1253 (0.16%)  2
Elevated DFT - Defibrillation  1  0/1247 (0.00%)  0 3/1253 (0.24%)  3
PG system - Therapy  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Inappropriate AV Delay  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Inappropriate tachy therapy - SVT  1  20/1247 (1.60%)  23 22/1253 (1.76%)  33
Inappropriate tachy therapy - NSR  1  4/1247 (0.32%)  4 6/1253 (0.48%)  6
Inappropriate tachy therapy - Noise  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
Inappropriate tachy therapy - Other  1  4/1247 (0.32%)  4 1/1253 (0.08%)  1
Early ERI - Premature declaration  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Pacemaker-mediated tachycardia  1  6/1247 (0.48%)  6 3/1253 (0.24%)  4
PG system - Diagnosis  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Inability to maintain telemetry  1  0/1247 (0.00%)  0 5/1253 (0.40%)  5
PG System - Patient related  1  6/1247 (0.48%)  6 3/1253 (0.24%)  3
Adverse reaction - Bradycardia  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Inadvertent VT/VF  1  1/1247 (0.08%)  1 2/1253 (0.16%)  2
Inadvertent SVT  1  5/1247 (0.40%)  5 4/1253 (0.32%)  4
Oversensing - RA  1  3/1247 (0.24%)  3 2/1253 (0.16%)  2
Undersensing - RA  1  1/1247 (0.08%)  1 2/1253 (0.16%)  2
Unable to capture - RA  1  1/1247 (0.08%)  1 3/1253 (0.24%)  3
Elevated threshold - RA  1  6/1247 (0.48%)  6 10/1253 (0.80%)  10
Extracardiac stimulation - RA  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Electrode damaged - RA  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Impedance > 2000 ohms - RA  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Dislodgment - Unable to capture – RA  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Dislodgment - Elevated threshold - RA  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Dislodgment - Extracardiac stimulation- RA  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Dislodgment - Multiple signs - RA  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Dislodgment - No reported signs - RA  1  1/1247 (0.08%)  1 3/1253 (0.24%)  3
Other - Lead  1  4/1247 (0.32%)  4 8/1253 (0.64%)  9
Oversensing - RV  1  3/1247 (0.24%)  3 1/1253 (0.08%)  1
Unable to capture - RV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Elevated threshold - RV  1  16/1247 (1.28%)  16 15/1253 (1.20%)  15
Conductor coil fracture - RV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Impedance < 300 ohms - RV  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Dislodgment - Elevated threshold -RV  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
Dislodgment - Multiple signs - RV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Dislodgment - No reported signs - RV  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Unable to capture - LV  1  4/1247 (0.32%)  4 1/1253 (0.08%)  1
Elevated threshold - LV  1  19/1247 (1.52%)  20 21/1253 (1.68%)  21
Extracardiac stimulation - LV  1  32/1247 (2.57%)  41 36/1253 (2.87%)  45
Electrode damaged - LV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Dislodgment - Unable to capture - LV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Dislodgment - Elevated threshold - LV  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Dislodgment - Multiple signs - LV  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Dislodgment - No reported signs -LV  1  3/1247 (0.24%)  3 1/1253 (0.08%)  1
Defibrillation lead  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Oversensing - Defibrillation lead  1  2/1247 (0.16%)  2 2/1253 (0.16%)  2
Undersensing - Defibrillation lead  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Elevated DFT - Defibrillation lead  1  2/1247 (0.16%)  2 2/1253 (0.16%)  2
Patient CONDITION Cardiovascular  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Bradyarrhythmias - unspecific  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
1st degree AV block  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
2nd degree AV block  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
3rd degree AV block  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Sinus bradycardia  1  3/1247 (0.24%)  3 4/1253 (0.32%)  4
Chronotropic incompetence  1  3/1247 (0.24%)  3 2/1253 (0.16%)  2
Ventricular tachyarrhythmias - unspecified  1  3/1247 (0.24%)  3 2/1253 (0.16%)  2
Ventricular fibrillation (VF)  1  2/1247 (0.16%)  7 5/1253 (0.40%)  5
Ventricular tachycardia (VT)  1  23/1247 (1.84%)  25 33/1253 (2.63%)  39
Nonsustained ventricular tachycardia (NSVT)  1  7/1247 (0.56%)  10 14/1253 (1.12%)  17
Accelerated idiopathic rhythm  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Atrial Tachyarrhythmias - unspecific  1  6/1247 (0.48%)  6 1/1253 (0.08%)  1
Atrial fibrillation (AF)  1  45/1247 (3.61%)  49 43/1253 (3.43%)  49
Atrial flutter  1  12/1247 (0.96%)  13 6/1253 (0.48%)  6
Sinus Tachycardia  1  1/1247 (0.08%)  1 3/1253 (0.24%)  3
Other SVT (eg AVRT, AVNRT, EAT)  1  4/1247 (0.32%)  4 5/1253 (0.40%)  6
Premature ventricular contractions (PVC)  1  7/1247 (0.56%)  7 5/1253 (0.40%)  6
Syncope - Heart failure  1  3/1247 (0.24%)  3 0/1253 (0.00%)  0
Dizziness - Heart failure  1  4/1247 (0.32%)  5 2/1253 (0.16%)  4
Chest pain - Heart failure  1  1/1247 (0.08%)  1 4/1253 (0.32%)  4
Dyspnea - Heart failure  1  34/1247 (2.73%)  37 29/1253 (2.31%)  29
Peripheral edema - Heart failure  1  15/1247 (1.20%)  15 11/1253 (0.88%)  11
Fatigue - Heart failure  1  6/1247 (0.48%)  6 6/1253 (0.48%)  8
Dehydration - Heart failure  1  2/1247 (0.16%)  2 1/1253 (0.08%)  1
Weight gain - Heart failure  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Heart failure symptoms - Unspecified  1  10/1247 (0.80%)  10 5/1253 (0.40%)  5
Multiple heart failure symptoms  1  31/1247 (2.49%)  34 33/1253 (2.63%)  39
Hypertension - Heart failure  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
Other- Heart failure patient condition – Cardiovascular  1  5/1247 (0.40%)  5 2/1253 (0.16%)  2
Myocardial infarction  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Valve related - unspecific  1  2/1247 (0.16%)  2 1/1253 (0.08%)  1
Chest pain – Ischemic  1  10/1247 (0.80%)  11 11/1253 (0.88%)  11
Intracardiac thrombus  1  3/1247 (0.24%)  3 2/1253 (0.16%)  2
Endocrine disorders     
Endocrine  1  41/1247 (3.29%)  49 38/1253 (3.03%)  44
Gastrointestinal disorders     
Gastrointestinal  1  49/1247 (3.93%)  62 56/1253 (4.47%)  64
General disorders     
Adverse reaction - General  1  6/1247 (0.48%)  6 2/1253 (0.16%)  2
Chest pain  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Syncope  1  43/1247 (3.45%)  48 27/1253 (2.15%)  31
Dizziness  1  26/1247 (2.09%)  30 36/1253 (2.87%)  38
Chest pain – Other  1  17/1247 (1.36%)  28 19/1253 (1.52%)  23
Dyspnea  1  19/1247 (1.52%)  20 12/1253 (0.96%)  12
Palpitations  1  12/1247 (0.96%)  13 9/1253 (0.72%)  9
Fatigue  1  10/1247 (0.80%)  10 6/1253 (0.48%)  6
Multiple Symptoms  1  1/1247 (0.08%)  1 4/1253 (0.32%)  4
WHOLE BODY  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
Fever  1  8/1247 (0.64%)  8 1/1253 (0.08%)  1
Physical trauma  1  41/1247 (3.29%)  46 30/1253 (2.39%)  31
Head, eyes, ears, nose, throat (HEENT)  1  53/1247 (4.25%)  61 49/1253 (3.91%)  53
  1  16/1247 (1.28%)  17 21/1253 (1.68%)  23
Adverse drug reaction  1  26/1247 (2.09%)  30 25/1253 (2.00%)  27
  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Immune system disorders     
Adverse reaction – Allergic reaction  1  6/1247 (0.48%)  6 7/1253 (0.56%)  7
Immune  1  2/1247 (0.16%)  2 1/1253 (0.08%)  1
Infections and infestations     
PG system - Infection (> 30 days post implant)  1  5/1247 (0.40%)  5 3/1253 (0.24%)  3
Post-surgical infection (<= 30 days post-implant)  1  8/1247 (0.64%)  8 4/1253 (0.32%)  5
Systemic infection  1  17/1247 (1.36%)  18 3/1253 (0.24%)  3
Musculoskeletal and connective tissue disorders     
Musculoskeletal  1  51/1247 (4.09%)  61 49/1253 (3.91%)  52
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer  1  14/1247 (1.12%)  17 13/1253 (1.04%)  15
Nervous system disorders     
Neurological  1  16/1247 (1.28%)  17 16/1253 (1.28%)  24
Psychiatric disorders     
Psychological effect due to device therapy  1  3/1247 (0.24%)  4 3/1253 (0.24%)  3
Psychological  1  8/1247 (0.64%)  8 14/1253 (1.12%)  14
Renal and urinary disorders     
Renal insufficiency - Heart failure  1  3/1247 (0.24%)  3 2/1253 (0.16%)  2
Genitourinary  1  38/1247 (3.05%)  49 28/1253 (2.23%)  32
Renal  1  20/1247 (1.60%)  22 14/1253 (1.12%)  14
Respiratory, thoracic and mediastinal disorders     
Adverse reaction - Respiratory  1  0/1247 (0.00%)  0 3/1253 (0.24%)  3
Pulmonary edema - Heart failure  1  5/1247 (0.40%)  6 2/1253 (0.16%)  2
COPD exacerbation  1  7/1247 (0.56%)  7 5/1253 (0.40%)  5
Pulmonary  1  48/1247 (3.85%)  54 59/1253 (4.71%)  68
Skin and subcutaneous tissue disorders     
Migration  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Integumentary  1  30/1247 (2.41%)  32 30/1253 (2.39%)  32
Surgical and medical procedures     
Hematoma - Pocket (> 30 days post implant)  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
Post-surgical wound discomfort  1  20/1247 (1.60%)  20 21/1253 (1.68%)  24
Post-surgical pocket hemorrhage  1  2/1247 (0.16%)  2 2/1253 (0.16%)  2
Adverse reaction - Hypotension  1  3/1247 (0.24%)  3 4/1253 (0.32%)  4
Vasovagal  1  5/1247 (0.40%)  5 2/1253 (0.16%)  2
Hemodynamic instability - DFT testing  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
Hemorrhage  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Physical trauma  1  6/1247 (0.48%)  6 7/1253 (0.56%)  9
Hematoma - Pocket (<=30 days post-implant)  1  60/1247 (4.81%)  61 51/1253 (4.07%)  51
Seroma - Pocket (<=30 days post-implant)  1  4/1247 (0.32%)  4 2/1253 (0.16%)  2
Thromboembolic events  1  3/1247 (0.24%)  3 10/1253 (0.80%)  10
Other - PG system – Procedure  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Arterial perforation - Procedure  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Pneumothorax - Procedure  1  2/1247 (0.16%)  2 4/1253 (0.32%)  4
Renal failure due to contrast media – Procedure  1  1/1247 (0.08%)  1 1/1253 (0.08%)  1
Pleural effusion - Procedure  1  4/1247 (0.32%)  4 4/1253 (0.32%)  4
Coronary venous dissection  1  8/1247 (0.64%)  8 3/1253 (0.24%)  3
AV block (transient) - Procedure  1  3/1247 (0.24%)  3 0/1253 (0.00%)  0
Pericardial effusion  1  1/1247 (0.08%)  1 2/1253 (0.16%)  2
Other - Lead – Procedure  1  23/1247 (1.84%)  24 27/1253 (2.15%)  27
Procedure related complication other than implant procedure  1  7/1247 (0.56%)  10 4/1253 (0.32%)  4
Pericardial effusion - Unrelated to procedure  1  1/1247 (0.08%)  1 0/1253 (0.00%)  0
Pericarditis  1  1/1247 (0.08%)  2 0/1253 (0.00%)  0
Hematoma  1  5/1247 (0.40%)  5 3/1253 (0.24%)  3
Hemorrhage  1  2/1247 (0.16%)  2 0/1253 (0.00%)  0
Vascular disorders     
Hypotension  1  22/1247 (1.76%)  22 19/1253 (1.52%)  19
Hypertension  1  9/1247 (0.72%)  9 15/1253 (1.20%)  18
Coronary Artery Disease  1  18/1247 (1.44%)  19 14/1253 (1.12%)  14
Vascular disease - unspecific  1  6/1247 (0.48%)  6 4/1253 (0.32%)  4
Peripheral vascular disease  1  12/1247 (0.96%)  12 5/1253 (0.40%)  7
Thromboembolic events - unspecific  1  2/1247 (0.16%)  2 1/1253 (0.08%)  1
Transient ischemic attack (TIA)  1  5/1247 (0.40%)  5 3/1253 (0.24%)  3
Cerebrovascular accident (CVA)  1  0/1247 (0.00%)  0 2/1253 (0.16%)  2
Deep vein thrombosis (DVT)  1  0/1247 (0.00%)  0 1/1253 (0.08%)  1
Distal thromboemboli  1  4/1247 (0.32%)  4 1/1253 (0.08%)  1
Vasovagal reaction  1  5/1247 (0.40%)  5 5/1253 (0.40%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, BSC coding list
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Dr. Jeff Healey
Organization: Population Health Research Institute, McMaster University
Phone: 001 905 330 6760
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00800384     History of Changes
Other Study ID Numbers: 11-2007
First Submitted: November 27, 2008
First Posted: December 2, 2008
Results First Submitted: October 13, 2015
Results First Posted: December 22, 2015
Last Update Posted: March 30, 2018