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

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ClinicalTrials.gov Identifier: NCT01781078

Recruitment Status : Completed

First Posted : January 31, 2013

Results First Posted : April 11, 2017

Last Update Posted : December 3, 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

Participant Flow

Recruitment Details	363 patients were consented and enrolled in this study. 11 patients were withdrawn pre-implantation. 352 patients underwent the implantation procedure and 348 patients were successfully implanted. 1 patient died prior to randomization.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Arm/Group Title	MRI Group	Control Group	Patients Withdrawn Prior to Randomization
Arm/Group Description	Those subjects randomized to the MR...	Those subjects randomized to the Co...	Patients who consented to the study...
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 ImageReady System implant: Pacemaker and lead(s) implant	Patients who consented to the study but were withdrawn prior to the randomization.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)

Baseline Characteristics

Arm/Group Title		MRI Group	Control Group	Total
Arm/Group Description		Those subjects randomized to the MR...	Those subjects randomized to the Co...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

1.Primary Outcome


Title	Proportion of Participants Without MR Scan-related Complications
Description	The primary safety endpoint for SAMURAI will be assessed for all subje...
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

Outcome Measure Data

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
Arm/Group Description:	Those subjects randomized to the MR...
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
Description	The MRI scan can result in damage to cardiac tissue surrounding lead e...
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

Outcome Measure Data

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
Arm/Group Description:	Those subjects randomized to the MR...	Those subjects randomized to the Co...
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

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
Description	The MRI scan can result in damage to cardiac tissue surrounding lead e...
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

Outcome Measure Data

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
Arm/Group Description:		Those subjects randomized to the Co...	Those subjects randomized to the MR...
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
Right Atrium (RA)		96.2	96.3
Right Ventricle (RV)	Number Analyzed	91 participants	152 participants
Right Ventricle (RV)		96.7	96.7

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]

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
Description	Overall safety of the ImageReady System will be confirmed by evaluatin...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	All Subjects Who Underwent an Implant Procedure
Arm/Group Description:	All subjects who underwent an impla...
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)

Adverse Events

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
Arm/Group Description	Those subjects randomized to the MR...		Those subjects randomized to the Co...
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	--/--		--/--
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

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Name/Title:	Kelly Aspinwall
Organization:	Boston Scientific
Phone:	651-582-4560
EMail:	Kelly.Aspinwall@bsci.com

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Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT01781078
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:	December 3, 2019

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