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Trial record 48 of 62 for:    "Sick Sinus Syndrome"

ImageReady(TM) MR Conditional Pacing System Clinical Study (SAMURAI)

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: NCT01781078
Recruitment Status : Active, not recruiting
First Posted : January 31, 2013
Results First Posted : April 11, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bradycardia
Sinus Node Dysfunction
Interventions Radiation: MRI
Device: ImageReady System implant
Enrollment 363
Recruitment Details 363 patients were consented and enrolled in this study. 11 patients were withdrawn pre-implantation. 352 patients underwent the implantation procedure and 348 patients were successfully implanted. 1 patient died prior to randomization.
Pre-assignment Details  
Arm/Group Title MRI Group Control Group Patients Withdrawn Prior to Randomization
Hide Arm/Group Description

Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

ImageReady System implant: Pacemaker and lead(s) implant

Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.

ImageReady System implant: Pacemaker and lead(s) implant

Patients who consented to the study but were withdrawn prior to the randomization.
Period Title: Overall Study
Started 229 [1] 118 [1] 16
Completed 217 [2] 113 [2] 0
Not Completed 12 5 16
[1]
Randomized post implantation
[2]
Patients having completed the MRI + 1 month (Primary endpoint assessment)
Arm/Group Title MRI Group Control Group Total
Hide Arm/Group Description

Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

ImageReady System implant: Pacemaker and lead(s) implant

Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.

ImageReady System implant: Pacemaker and lead(s) implant

Total of all reporting groups
Overall Number of Baseline Participants 229 118 347
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 229 participants 118 participants 347 participants
69.0  (13.0) 70.4  (11.9) 69.4  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants 118 participants 347 participants
Female
102
  44.5%
63
  53.4%
165
  47.6%
Male
127
  55.5%
55
  46.6%
182
  52.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants 118 participants 347 participants
Canada
6
   2.6%
2
   1.7%
8
   2.3%
Singapore
12
   5.2%
8
   6.8%
20
   5.8%
United States
162
  70.7%
83
  70.3%
245
  70.6%
China
7
   3.1%
3
   2.5%
10
   2.9%
Malaysia
21
   9.2%
8
   6.8%
29
   8.4%
Israel
21
   9.2%
13
  11.0%
34
   9.8%
Australia
0
   0.0%
1
   0.8%
1
   0.3%
1.Primary Outcome
Title Proportion of Participants Without MR Scan-related Complications
Hide Description The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.
Time Frame MRI Visit + 1 Month
Hide Outcome Measure Data
Hide Analysis Population Description
The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who underwent any portion of the MRI scan sequences and did not have a medically necessary scan performed prior to the MRI visit + 1 month follow-up.
Arm/Group Title MRI Group
Hide Arm/Group Description:

Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

ImageReady System implant: Pacemaker and lead(s) implant

Overall Number of Participants Analyzed 180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100
(100 to 100)
2.Primary Outcome
Title Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit
Hide Description

The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up.

Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups.

Time Frame MRI + 1 Month Visit
Hide Outcome Measure Data
Hide Analysis Population Description
For the per-protocol analysis, a total of 96 Control Group subjects and 167 MRI Group subjects had paired threshold measurements and met the inclusion criteria.
Arm/Group Title MRI Group Control Group
Hide Arm/Group Description:

Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

ImageReady System implant: Pacemaker and lead(s) implant

Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups.

ImageReady System implant: Pacemaker and lead(s) implant

Overall Number of Participants Analyzed 167 96
Measure Type: Number
Unit of Measure: % of participants with success
98.2 97.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MRI Group, Control Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Farrington-Manning score test
Comments [Not Specified]
Method of Estimation Estimation Parameter difference
Estimated Value -0.3
Confidence Interval (1-Sided) 95%
3.9
Estimation Comments [Not Specified]
3.Primary Outcome
Title Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit
Hide Description The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint.
Time Frame MRI + 1 Month Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Right Atrium: a total of 78 Control Group subjects and 135 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria. Right Ventricle: a total of 91 Control Group subjects and 152 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria.
Arm/Group Title Control Group MRI Group
Hide Arm/Group Description:

Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups.

ImageReady System implant: Pacemaker and lead(s) implant

Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

ImageReady System implant: Pacemaker and lead(s) implant

Overall Number of Participants Analyzed 169 287
Measure Type: Number
Unit of Measure: % of participants with success
Right Atrium (RA) Number Analyzed 78 participants 135 participants
96.2 96.3
Right Ventricle (RV) Number Analyzed 91 participants 152 participants
96.7 96.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, MRI Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Farrington-Manning score test
Comments [Not Specified]
Method of Estimation Estimation Parameter difference
Estimated Value -0.1
Confidence Interval (1-Sided) 95%
5.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, MRI Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Farrington-Manning score test
Comments [Not Specified]
Method of Estimation Estimation Parameter difference
Estimated Value -0.0
Confidence Interval (1-Sided) 95%
4.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Participants Without ImageReady System-related Complications
Hide Description Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for all subjects who underwent an implant procedure and and reached 91 days of follow-up.
Time Frame 3 months post implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Who Underwent an Implant Procedure
Hide Arm/Group Description:
All subjects who underwent an implant procedure and reached 91 days of follow-up.
Overall Number of Participants Analyzed 326
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
94.5
(91.9 to 94.5)
Time Frame Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant.
Adverse Event Reporting Description All Adverse Events are collected, as per ISO 14155: 2011 and/or 21 CFR Part 812.
 
Arm/Group Title MRI Group Control Group
Hide Arm/Group Description

Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

ImageReady System implant: Pacemaker and lead(s) implant

Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.

ImageReady System implant: Pacemaker and lead(s) implant

All-Cause Mortality
MRI Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MRI Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   123/229 (53.71%)      67/118 (56.78%)    
Blood and lymphatic system disorders     
Hematological *  2/229 (0.87%)  2 3/118 (2.54%)  3
Cardiac disorders     
Dyspnea - Heart failure *  5/229 (2.18%)  6 1/118 (0.85%)  1
Pulmonary edema - Heart failure *  1/229 (0.44%)  1 0/118 (0.00%)  0
Fatigue - Heart failure *  0/229 (0.00%)  0 1/118 (0.85%)  1
Heart failure symptoms - Unspecified *  7/229 (3.06%)  7 4/118 (3.39%)  5
Multiple heart failure symptoms *  8/229 (3.49%)  9 5/118 (4.24%)  5
Hypertension - Heart failure *  0/229 (0.00%)  0 1/118 (0.85%)  1
Other - Heart failure patient condition *  3/229 (1.31%)  3 3/118 (2.54%)  3
3rd degree AV block *  1/229 (0.44%)  1 0/118 (0.00%)  0
Ventricular fibrillation (VF) *  2/229 (0.87%)  2 0/118 (0.00%)  0
Ventricular tachycardia (VT) *  1/229 (0.44%)  1 0/118 (0.00%)  0
Torsades des pointes *  0/229 (0.00%)  0 1/118 (0.85%)  1
Nonsustained ventricular tachycardia (NSVT) *  1/229 (0.44%)  1 2/118 (1.69%)  2
Atrial fibrillation (AF) *  12/229 (5.24%)  21 9/118 (7.63%)  9
Atrial flutter *  5/229 (2.18%)  7 4/118 (3.39%)  5
Other SVT (AVRT, AVNRT, EAT etc.) *  2/229 (0.87%)  3 3/118 (2.54%)  3
Hypotension *  4/229 (1.75%)  4 0/118 (0.00%)  0
Hypertension *  2/229 (0.87%)  2 0/118 (0.00%)  0
Cardiac arrest *  2/229 (0.87%)  2 1/118 (0.85%)  1
Myocardial infarction *  5/229 (2.18%)  5 1/118 (0.85%)  1
Peripheral vascular disease *  2/229 (0.87%)  2 0/118 (0.00%)  0
Aortic stenosis *  4/229 (1.75%)  5 1/118 (0.85%)  2
Mitral regurgitation *  0/229 (0.00%)  0 1/118 (0.85%)  1
Syncope *  5/229 (2.18%)  5 2/118 (1.69%)  4
Dizziness *  3/229 (1.31%)  3 2/118 (1.69%)  2
Chest pain - Ischemic *  6/229 (2.62%)  6 1/118 (0.85%)  1
Chest pain - Other *  12/229 (5.24%)  14 2/118 (1.69%)  2
Dyspnea *  5/229 (2.18%)  5 0/118 (0.00%)  0
Palpitations *  1/229 (0.44%)  1 1/118 (0.85%)  1
Multiple symptoms *  1/229 (0.44%)  1 1/118 (0.85%)  1
Transient ischemic attack (TIA) *  2/229 (0.87%)  2 1/118 (0.85%)  1
Cerebrovascular accident (CVA) *  4/229 (1.75%)  4 4/118 (3.39%)  4
Deep vein thrombosis (DVT) *  3/229 (1.31%)  3 1/118 (0.85%)  1
Pulmonary embolism (PE) *  1/229 (0.44%)  1 0/118 (0.00%)  0
Intracardiac thrombus *  1/229 (0.44%)  1 0/118 (0.00%)  0
Hemorrhage *  1/229 (0.44%)  1 1/118 (0.85%)  1
Other - Patient condition *  4/229 (1.75%)  5 0/118 (0.00%)  0
AV Block Intermittent *  13/229 (5.68%)  14 0/118 (0.00%)  0
Endocrine disorders     
Endocrine *  6/229 (2.62%)  6 0/118 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal *  21/229 (9.17%)  24 11/118 (9.32%)  14
General disorders     
Other - Patient condition *  3/229 (1.31%)  3 2/118 (1.69%)  2
Death *  1/229 (0.44%)  1 0/118 (0.00%)  0
Physical trauma *  7/229 (3.06%)  8 5/118 (4.24%)  6
Abnormal laboratory values *  2/229 (0.87%)  2 0/118 (0.00%)  0
Head, eyes, ears, nose, throat (HEENT) *  9/229 (3.93%)  10 5/118 (4.24%)  6
Multi-system failure *  1/229 (0.44%)  1 0/118 (0.00%)  0
Adverse Reaction - Allergic *  0/229 (0.00%)  0 3/118 (2.54%)  8
Infections and infestations     
Systemic infection *  5/229 (2.18%)  6 3/118 (2.54%)  4
Fever *  1/229 (0.44%)  1 1/118 (0.85%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal *  18/229 (7.86%)  21 5/118 (4.24%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer *  10/229 (4.37%)  11 4/118 (3.39%)  4
Nervous system disorders     
Neurological *  9/229 (3.93%)  12 2/118 (1.69%)  2
Product Issues     
Early ERI - Random component failure *  1/229 (0.44%)  1 0/118 (0.00%)  0
Erosion *  1/229 (0.44%)  1 0/118 (0.00%)  0
Infection (> 30 days post-implant) *  1/229 (0.44%)  1 0/118 (0.00%)  0
Impedance > 2000 ohms - RA *  1/229 (0.44%)  1 0/118 (0.00%)  0
Dislodgment - RA *  3/229 (1.31%)  3 2/118 (1.69%)  2
Other - RA Lead *  1/229 (0.44%)  1 1/118 (0.85%)  1
Elevated threshold - RV *  1/229 (0.44%)  1 0/118 (0.00%)  0
Myocardial perforation post-implant - RV *  3/229 (1.31%)  3 1/118 (0.85%)  1
Impedance > 2000 ohms - RV *  1/229 (0.44%)  1 0/118 (0.00%)  0
Dislodgment - RV *  2/229 (0.87%)  2 1/118 (0.85%)  1
Psychiatric disorders     
Psychological *  1/229 (0.44%)  1 2/118 (1.69%)  2
Renal and urinary disorders     
Renal *  9/229 (3.93%)  12 1/118 (0.85%)  1
Reproductive system and breast disorders     
Genitourinary *  8/229 (3.49%)  15 1/118 (0.85%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary *  22/229 (9.61%)  28 5/118 (4.24%)  14
Skin and subcutaneous tissue disorders     
Integumentary *  9/229 (3.93%)  11 2/118 (1.69%)  2
Surgical and medical procedures     
Post-surgical infection (<= 30 days post-implant) *  0/229 (0.00%)  0 2/118 (1.69%)  2
Adverse reaction - General *  2/229 (0.87%)  2 0/118 (0.00%)  0
Physical trauma *  1/229 (0.44%)  1 0/118 (0.00%)  0
Myocardial perforation without tamponade *  1/229 (0.44%)  1 1/118 (0.85%)  1
Myocardial perforation with tamponade *  1/229 (0.44%)  1 1/118 (0.85%)  1
Venous occlusion *  1/229 (0.44%)  1 0/118 (0.00%)  0
Adverse reaction - General *  1/229 (0.44%)  1 0/118 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MRI Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   163/229 (71.18%)      82/118 (69.49%)    
Blood and lymphatic system disorders     
Hematological *  3/229 (1.31%)  4 2/118 (1.69%)  2
Cardiac disorders     
Dyspnea - Heart failure *  2/229 (0.87%)  2 0/118 (0.00%)  0
Peripheral edema - Heart failure *  0/229 (0.00%)  0 1/118 (0.85%)  1
Pulmonary edema - Heart failure *  0/229 (0.00%)  0 1/118 (0.85%)  1
Hypotension - Heart failure *  1/229 (0.44%)  1 0/118 (0.00%)  0
Heart failure symptoms - Unspecified *  1/229 (0.44%)  1 1/118 (0.85%)  1
Multiple heart failure symptoms *  3/229 (1.31%)  3 2/118 (1.69%)  3
Other - Heart failure patient condition *  3/229 (1.31%)  3 1/118 (0.85%)  1
Sinus bradycardia *  2/229 (0.87%)  2 1/118 (0.85%)  1
Chronotropic incompetence *  1/229 (0.44%)  1 2/118 (1.69%)  2
Ventricular tachycardia (VT) *  3/229 (1.31%)  4 0/118 (0.00%)  0
Nonsustained ventricular tachycardia (NSVT) *  26/229 (11.35%)  27 9/118 (7.63%)  10
Atrial fibrillation (AF) *  32/229 (13.97%)  40 11/118 (9.32%)  11
Atrial flutter *  3/229 (1.31%)  3 2/118 (1.69%)  2
Sinus tachycardia *  0/229 (0.00%)  0 1/118 (0.85%)  1
Other SVT (AVRT, AVNRT, EAT etc.) *  10/229 (4.37%)  13 6/118 (5.08%)  9
Premature ventricular contractions (PVC) *  3/229 (1.31%)  3 1/118 (0.85%)  1
Hypotension *  3/229 (1.31%)  6 0/118 (0.00%)  0
Hypertension *  8/229 (3.49%)  9 4/118 (3.39%)  4
Peripheral vascular disease *  2/229 (0.87%)  2 0/118 (0.00%)  0
Aortic stenosis *  1/229 (0.44%)  1 1/118 (0.85%)  1
Mitral regurgitation *  2/229 (0.87%)  2 0/118 (0.00%)  0
Syncope *  2/229 (0.87%)  8 4/118 (3.39%)  4
Dizziness *  16/229 (6.99%)  16 4/118 (3.39%)  5
Chest pain - Ischemic *  2/229 (0.87%)  2 0/118 (0.00%)  0
Chest pain - Other *  18/229 (7.86%)  24 7/118 (5.93%)  8
Dyspnea *  11/229 (4.80%)  11 3/118 (2.54%)  4
Palpitations *  8/229 (3.49%)  10 0/118 (0.00%)  0
Fatigue *  5/229 (2.18%)  5 2/118 (1.69%)  2
Multiple symptoms *  2/229 (0.87%)  2 7/118 (5.93%)  7
Cerebrovascular accident (CVA) *  1/229 (0.44%)  1 0/118 (0.00%)  0
Deep vein thrombosis (DVT) *  2/229 (0.87%)  2 0/118 (0.00%)  0
Distal thromboemboli *  1/229 (0.44%)  1 0/118 (0.00%)  0
Pericardial effusion - Unrelated to procedure *  0/229 (0.00%)  0 1/118 (0.85%)  1
Hematoma - Unrelated to procedure or device *  3/229 (1.31%)  4 0/118 (0.00%)  0
Other - Patient condition *  6/229 (2.62%)  6 5/118 (4.24%)  5
AV Block Intermittent *  12/229 (5.24%)  13 0/118 (0.00%)  0
Endocrine disorders     
Endocrine *  1/229 (0.44%)  1 2/118 (1.69%)  2
Gastrointestinal disorders     
Gastrointestinal *  30/229 (13.10%)  35 9/118 (7.63%)  13
General disorders     
Other - Patient condition *  6/229 (2.62%)  6 6/118 (5.08%)  7
Physical trauma *  26/229 (11.35%)  31 7/118 (5.93%)  8
Abnormal laboratory values *  6/229 (2.62%)  8 3/118 (2.54%)  4
Head, eyes, ears, nose, throat (HEENT) *  36/229 (15.72%)  49 20/118 (16.95%)  28
Adverse Reaction - Allergic *  0/229 (0.00%)  0 11/118 (9.32%)  13
Infections and infestations     
Systemic infection *  1/229 (0.44%)  2 0/118 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal *  27/229 (11.79%)  32 22/118 (18.64%)  35
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer *  1/229 (0.44%)  1 0/118 (0.00%)  0
Nervous system disorders     
Neurological *  19/229 (8.30%)  22 8/118 (6.78%)  10
Product Issues     
Oversensing - RA *  1/229 (0.44%)  1 0/118 (0.00%)  0
Undersensing - RA *  2/229 (0.87%)  2 1/118 (0.85%)  1
Other - PG system *  1/229 (0.44%)  1 1/118 (0.85%)  1
Oversensing - RV *  0/229 (0.00%)  0 1/118 (0.85%)  1
Rate response inappropriate *  3/229 (1.31%)  3 0/118 (0.00%)  0
Inappropriate AV delay *  1/229 (0.44%)  2 2/118 (1.69%)  2
Pacemaker-mediated tachycardia (PMT) *  6/229 (2.62%)  7 2/118 (1.69%)  2
Hematoma - Pocket (> 30 days post-implant) *  0/229 (0.00%)  0 1/118 (0.85%)  1
Oversensing - RA *  2/229 (0.87%)  2 0/118 (0.00%)  0
Undersensing - RA *  1/229 (0.44%)  1 2/118 (1.69%)  2
Extracardiac stimulation - RA *  2/229 (0.87%)  2 0/118 (0.00%)  0
Dislodgment - RA *  1/229 (0.44%)  1 0/118 (0.00%)  0
Other - RA Lead *  0/229 (0.00%)  0 2/118 (1.69%)  2
Oversensing - RV *  1/229 (0.44%)  1 0/118 (0.00%)  0
Undersensing - RV *  1/229 (0.44%)  1 0/118 (0.00%)  0
Elevated threshold - RV *  3/229 (1.31%)  3 0/118 (0.00%)  0
Extracardiac stimulation - RV *  1/229 (0.44%)  1 2/118 (1.69%)  2
Extracardiac stimulation - LV *  0/229 (0.00%)  0 1/118 (0.85%)  1
Psychiatric disorders     
Psychological *  6/229 (2.62%)  6 1/118 (0.85%)  1
Renal and urinary disorders     
Renal *  6/229 (2.62%)  6 1/118 (0.85%)  1
Reproductive system and breast disorders     
Genitourinary *  14/229 (6.11%)  14 14/118 (11.86%)  21
Respiratory, thoracic and mediastinal disorders     
Pulmonary *  11/229 (4.80%)  12 6/118 (5.08%)  6
Skin and subcutaneous tissue disorders     
Integumentary *  21/229 (9.17%)  25 9/118 (7.63%)  9
Surgical and medical procedures     
Post-surgical wound discomfort *  5/229 (2.18%)  5 5/118 (4.24%)  6
Post-surgical pocket hemorrhage *  1/229 (0.44%)  1 1/118 (0.85%)  1
Post-surgical infection (<= 30 days post-implant) *  3/229 (1.31%)  3 1/118 (0.85%)  1
Chest pain *  2/229 (0.87%)  2 1/118 (0.85%)  1
Hematoma - Pocket (<=30 days post-implant) *  2/229 (0.87%)  2 3/118 (2.54%)  3
Puncture site hematoma - Procedure *  1/229 (0.44%)  1 0/118 (0.00%)  0
Pneumothorax - Procedure *  1/229 (0.44%)  1 0/118 (0.00%)  0
Myocardial perforation without tamponade *  0/229 (0.00%)  0 1/118 (0.85%)  1
Venous occlusion *  1/229 (0.44%)  1 0/118 (0.00%)  0
Other - PG system procedure *  0/229 (0.00%)  0 2/118 (1.69%)  2
Protocol Testing - Adverse reaction - General *  2/229 (0.87%)  2 0/118 (0.00%)  0
Other - Protocol Testing *  3/229 (1.31%)  3 0/118 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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.
The restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor can request changes to the communication.
Results Point of Contact
Name/Title: Kelly Aspinwall
Organization: Boston Scientific
Phone: 651-582-4560
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01781078     History of Changes
Other Study ID Numbers: BSC-CDM00047737
First Submitted: January 25, 2013
First Posted: January 31, 2013
Results First Submitted: April 7, 2017
Results First Posted: April 11, 2017
Last Update Posted: April 17, 2019