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

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01781078
• Collaborator: (none)
• Enrollment: 363
• Locations: 41
• Arms: 2
• Duration (Months): 79.3
• Patients Per Site: 8.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with the Conditions of Use included in the Boston Scientific MRI Technical Guide

Condition or Disease	Intervention/Treatment	Phase
Bradycardia; Sinus Node Dysfunction	Radiation: MRI; Device: ImageReady System implant	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 363 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ImageReady(TM) MR Conditional Pacing System Clinical Study
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Sep 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MRI Group Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.	Radiation: MRI; The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment; Other Names: MR Scan ; Device: ImageReady System implant; Pacemaker and lead(s) implant; Other Names: Single chamber pacemaker implant Dual chamber pacemaker implant Pace/ Sense pacemaker lead implant
Experimental: Control Group 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.	Device: ImageReady System implant; Pacemaker and lead(s) implant; Other Names: Single chamber pacemaker implant Dual chamber pacemaker implant Pace/ Sense pacemaker lead implant

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants Without MR Scan-related Complications [MRI Visit + 1 Month]

   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.

2. Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit [MRI + 1 Month Visit]

   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.

3. Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit [MRI + 1 Month Visit]

   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.

Secondary Outcome Measures

1. Proportion of Participants Without ImageReady System-related Complications [3 months post implant]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject must have the ImageReady System as their initial (de novo) pacing system implant

• Subject has a Class I or II indication for implantation of a single or dual chamber pacemaker according to the ACC/AHA/HRS, or ESC guidelines, as appropriate per geography

• Subject is able and willing to undergo an MRI scan without intravenous sedation

• Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol

• Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

• Subject has or has had any pacing or ICD system implants

• Subject has any MR Unsafe implants or devices with an unknown MR status, including MR Unsafe sternal wires, neurostimulators, biostimulator, metals or alloys, per labeling of each implant

• Subject has any MR Conditional implants or devices that impact the ability to conduct this protocol

• Subject needs or will need another MR scan within 14 weeks of system implant, other than that required by the SAMURAI Study

• Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)

• Subject has a mechanical tricuspid heart valve

• Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries* that are not in conflict and do not affect the following:

• Schedule of procedures for the SAMURAI Study (i.e. should not cause additional or missed visits);

• SAMURAI Study outcome (i.e. involve medications that could affect pacing thresholds);

• Conduct of the SAMURAI Study per GCP/ ISO 14155:2011/ local regulations

• Subjects with documented permanent or persistent AF where the physician intends to implant a dual chamber pulse generator (single chamber VVIR pulse generators are acceptable)

• Subject is currently on the active heart transplant list

• Subject has documented life expectancy of less than 12 months

• Women of childbearing potential who are or might be pregnant at the time of study enrollment or ImageReady MR Conditional Pacing System implant (method of assessment upon physician's discretion)

• Subjects currently requiring dialysis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner Heart Hospital	Mesa	Arizona	United States	85206
2	USC Medical Center	Los Angeles	California	United States	90033
3	University of California, San Francisco	San Francisco	California	United States	94143
4	Washington Hospital Center	Washington	District of Columbia	United States	20010
5	Orlando Regional Medical Center	Orlando	Florida	United States	32806
6	University Community Hospital	Trinity	Florida	United States	34655
7	Emory University Hospital	Atlanta	Georgia	United States	30322
8	University of Chicago Hospital	Chicago	Illinois	United States	60637
9	Alexian Brothers Medical Center	Elk Grove Village	Illinois	United States	60007
10	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
11	William Beaumont Hospital	Royal Oak	Michigan	United States	48098
12	St Mary's Duluth Clinic Regional Heart Center	Duluth	Minnesota	United States	55805
13	United Heart and Vascular Clinic	Saint Paul	Minnesota	United States	55102
14	Billings Clinic	Billings	Montana	United States	59101
15	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
16	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
17	OhioHealth Research and Innovation Institute	Columbus	Ohio	United States	43214
18	Trinity West Hospital	Steubenville	Ohio	United States	43952
19	Abington Memorial Hospital	Philadelphia	Pennsylvania	United States	19001
20	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
21	Avera Heart Hospital of South Dakota	Sioux Falls	South Dakota	United States	57108
22	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	United States	78705
23	Medical City Dallas Hospital	Dallas	Texas	United States	75230
24	Trinity Mother Health Systems	Tyler	Texas	United States	75701
25	Martha Jefferson Hospital	Charlottesville	Virginia	United States	22911
26	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
27	Virginia Commonwealth University Health System	Richmond	Virginia	United States	23219
28	University of Washington Medical Center	Seattle	Washington	United States	98195
29	Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
30	St Vincent's Hospital	Melbourne	Victoria	Australia
31	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Ste Foy	Quebec	Canada
32	Queen Mary Hospital	Hong Kong	Hong Kong	China	00000
33	Hillel Yaffe Medical Center	Hadera		Israel
34	Rambam Medical Center	Haifa		Israel	31096
35	The Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239
36	Sheba Medical Center	Tel Hashomer		Israel
37	Institut Jantung Negara	Kuala Lumpur		Malaysia	50400
38	University Malaya Medical Center	Kuala Lumpur		Malaysia	50603
39	National Heart Centre	Singapore		Singapore	168752
40	National University Hospital, Singapore	Singapore		Singapore
41	Tan Tock Seng Hospital	Singapore		Singapore

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Ronald Berger, MD, PhD, Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01781078
• Other Study ID Numbers: BSC-CDM00047737
• First Posted: Jan 31, 2013
• Last Update Posted: Dec 3, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Boston Scientific Corporation: Single chamber pacing; Dual chamber pacing; MRI; MR scans
• Additional relevant MeSH terms: Bradycardia; Sick Sinus Syndrome

Study Results

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.

Arm/Group Title	MRI Group	Control Group	Patients Withdrawn Prior to Randomization
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	118	16
COMPLETED	217	113	0
NOT COMPLETED	12	5	16

Baseline Characteristics

Arm/Group Title	MRI Group	Control Group	Total
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 Participants	229	118	347
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.0 (13.0)	70.4 (11.9)	69.4 (12.8)
Sex: Female, Male (Count of Participants)
Female	102 44.5%	63 53.4%	165 47.6%
Male	127 55.5%	55 46.6%	182 52.4%
Region of Enrollment (Count of 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%	34 9.8%
Australia	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 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 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
Measure Participants	180
Number (95% Confidence Interval) [Percentage of participants]	100 43.7%

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 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 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
Measure Participants	167	96
Number [% of participants with success]	98.2 42.9%	97.9 83%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MRI Group, Control Group
	Comments
	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
	Method	Farrington-Manning score test
	Comments
Method of Estimation	Estimation Parameter	difference
	Estimated Value	-0.3
	Confidence Interval	(1-Sided) 95%; to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

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 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 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
Measure Participants	169	287
Right Atrium (RA)	96.2 42%	96.3 81.6%
Right Ventricle (RV)	96.7 42.2%	96.7 81.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MRI Group, Control Group
	Comments
	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
	Method	Farrington-Manning score test
	Comments
Method of Estimation	Estimation Parameter	difference
	Estimated Value	-0.1
	Confidence Interval	(1-Sided) 95%; to 5.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MRI Group, Control Group
	Comments
	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
	Method	Farrington-Manning score test
	Comments
Method of Estimation	Estimation Parameter	difference
	Estimated Value	-0.0
	Confidence Interval	(1-Sided) 95%; to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Proportion of Participants Without ImageReady System-related Complications
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 implant procedure and reached 91 days of follow-up.
Measure Participants	326
Number (95% Confidence Interval) [Percentage of participants]	94.5 41.3%

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 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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MRI Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	123/229 (53.7%)		67/118 (56.8%)
Blood and lymphatic system disorders
Hematological	2/229 (0.9%)	2	3/118 (2.5%)	3
Cardiac disorders
Dyspnea - Heart failure	5/229 (2.2%)	6	1/118 (0.8%)	1
Pulmonary edema - Heart failure	1/229 (0.4%)	1	0/118 (0%)	0
Fatigue - Heart failure	0/229 (0%)	0	1/118 (0.8%)	1
Heart failure symptoms - Unspecified	7/229 (3.1%)	7	4/118 (3.4%)	5
Multiple heart failure symptoms	8/229 (3.5%)	9	5/118 (4.2%)	5
Hypertension - Heart failure	0/229 (0%)	0	1/118 (0.8%)	1
Other - Heart failure patient condition	3/229 (1.3%)	3	3/118 (2.5%)	3
3rd degree AV block	1/229 (0.4%)	1	0/118 (0%)	0
Ventricular fibrillation (VF)	2/229 (0.9%)	2	0/118 (0%)	0
Ventricular tachycardia (VT)	1/229 (0.4%)	1	0/118 (0%)	0
Torsades des pointes	0/229 (0%)	0	1/118 (0.8%)	1
Nonsustained ventricular tachycardia (NSVT)	1/229 (0.4%)	1	2/118 (1.7%)	2
Atrial fibrillation (AF)	12/229 (5.2%)	21	9/118 (7.6%)	9
Atrial flutter	5/229 (2.2%)	7	4/118 (3.4%)	5
Other SVT (AVRT, AVNRT, EAT etc.)	2/229 (0.9%)	3	3/118 (2.5%)	3
Hypotension	4/229 (1.7%)	4	0/118 (0%)	0
Hypertension	2/229 (0.9%)	2	0/118 (0%)	0
Cardiac arrest	2/229 (0.9%)	2	1/118 (0.8%)	1
Myocardial infarction	5/229 (2.2%)	5	1/118 (0.8%)	1
Peripheral vascular disease	2/229 (0.9%)	2	0/118 (0%)	0
Aortic stenosis	4/229 (1.7%)	5	1/118 (0.8%)	2
Mitral regurgitation	0/229 (0%)	0	1/118 (0.8%)	1
Syncope	5/229 (2.2%)	5	2/118 (1.7%)	4
Dizziness	3/229 (1.3%)	3	2/118 (1.7%)	2
Chest pain - Ischemic	6/229 (2.6%)	6	1/118 (0.8%)	1
Chest pain - Other	12/229 (5.2%)	14	2/118 (1.7%)	2
Dyspnea	5/229 (2.2%)	5	0/118 (0%)	0
Palpitations	1/229 (0.4%)	1	1/118 (0.8%)	1
Multiple symptoms	1/229 (0.4%)	1	1/118 (0.8%)	1
Transient ischemic attack (TIA)	2/229 (0.9%)	2	1/118 (0.8%)	1
Cerebrovascular accident (CVA)	4/229 (1.7%)	4	4/118 (3.4%)	4
Deep vein thrombosis (DVT)	3/229 (1.3%)	3	1/118 (0.8%)	1
Pulmonary embolism (PE)	1/229 (0.4%)	1	0/118 (0%)	0
Intracardiac thrombus	1/229 (0.4%)	1	0/118 (0%)	0
Hemorrhage	1/229 (0.4%)	1	1/118 (0.8%)	1
Other - Patient condition	4/229 (1.7%)	5	0/118 (0%)	0
AV Block Intermittent	13/229 (5.7%)	14	0/118 (0%)	0
Endocrine disorders
Endocrine	6/229 (2.6%)	6	0/118 (0%)	0
Gastrointestinal disorders
Gastrointestinal	21/229 (9.2%)	24	11/118 (9.3%)	14
General disorders
Other - Patient condition	3/229 (1.3%)	3	2/118 (1.7%)	2
Death	1/229 (0.4%)	1	0/118 (0%)	0
Physical trauma	7/229 (3.1%)	8	5/118 (4.2%)	6
Abnormal laboratory values	2/229 (0.9%)	2	0/118 (0%)	0
Head, eyes, ears, nose, throat (HEENT)	9/229 (3.9%)	10	5/118 (4.2%)	6
Multi-system failure	1/229 (0.4%)	1	0/118 (0%)	0
Adverse Reaction - Allergic	0/229 (0%)	0	3/118 (2.5%)	8
Infections and infestations
Systemic infection	5/229 (2.2%)	6	3/118 (2.5%)	4
Fever	1/229 (0.4%)	1	1/118 (0.8%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal	18/229 (7.9%)	21	5/118 (4.2%)	6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	10/229 (4.4%)	11	4/118 (3.4%)	4
Nervous system disorders
Neurological	9/229 (3.9%)	12	2/118 (1.7%)	2
Product Issues
Early ERI - Random component failure	1/229 (0.4%)	1	0/118 (0%)	0
Erosion	1/229 (0.4%)	1	0/118 (0%)	0
Infection (> 30 days post-implant)	1/229 (0.4%)	1	0/118 (0%)	0
Impedance > 2000 ohms - RA	1/229 (0.4%)	1	0/118 (0%)	0
Dislodgment - RA	3/229 (1.3%)	3	2/118 (1.7%)	2
Other - RA Lead	1/229 (0.4%)	1	1/118 (0.8%)	1
Elevated threshold - RV	1/229 (0.4%)	1	0/118 (0%)	0
Myocardial perforation post-implant - RV	3/229 (1.3%)	3	1/118 (0.8%)	1
Impedance > 2000 ohms - RV	1/229 (0.4%)	1	0/118 (0%)	0
Dislodgment - RV	2/229 (0.9%)	2	1/118 (0.8%)	1
Psychiatric disorders
Psychological	1/229 (0.4%)	1	2/118 (1.7%)	2
Renal and urinary disorders
Renal	9/229 (3.9%)	12	1/118 (0.8%)	1
Reproductive system and breast disorders
Genitourinary	8/229 (3.5%)	15	1/118 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary	22/229 (9.6%)	28	5/118 (4.2%)	14
Skin and subcutaneous tissue disorders
Integumentary	9/229 (3.9%)	11	2/118 (1.7%)	2
Surgical and medical procedures
Post-surgical infection (<= 30 days post-implant)	0/229 (0%)	0	2/118 (1.7%)	2
Adverse reaction - General	2/229 (0.9%)	2	0/118 (0%)	0
Physical trauma	1/229 (0.4%)	1	0/118 (0%)	0
Myocardial perforation without tamponade	1/229 (0.4%)	1	1/118 (0.8%)	1
Myocardial perforation with tamponade	1/229 (0.4%)	1	1/118 (0.8%)	1
Venous occlusion	1/229 (0.4%)	1	0/118 (0%)	0
Adverse reaction - General	1/229 (0.4%)	1	0/118 (0%)	0
Other (Not Including Serious) Adverse Events
	MRI Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	163/229 (71.2%)		82/118 (69.5%)
Blood and lymphatic system disorders
Hematological	3/229 (1.3%)	4	2/118 (1.7%)	2
Cardiac disorders
Dyspnea - Heart failure	2/229 (0.9%)	2	0/118 (0%)	0
Peripheral edema - Heart failure	0/229 (0%)	0	1/118 (0.8%)	1
Pulmonary edema - Heart failure	0/229 (0%)	0	1/118 (0.8%)	1
Hypotension - Heart failure	1/229 (0.4%)	1	0/118 (0%)	0
Heart failure symptoms - Unspecified	1/229 (0.4%)	1	1/118 (0.8%)	1
Multiple heart failure symptoms	3/229 (1.3%)	3	2/118 (1.7%)	3
Other - Heart failure patient condition	3/229 (1.3%)	3	1/118 (0.8%)	1
Sinus bradycardia	2/229 (0.9%)	2	1/118 (0.8%)	1
Chronotropic incompetence	1/229 (0.4%)	1	2/118 (1.7%)	2
Ventricular tachycardia (VT)	3/229 (1.3%)	4	0/118 (0%)	0
Nonsustained ventricular tachycardia (NSVT)	26/229 (11.4%)	27	9/118 (7.6%)	10
Atrial fibrillation (AF)	32/229 (14%)	40	11/118 (9.3%)	11
Atrial flutter	3/229 (1.3%)	3	2/118 (1.7%)	2
Sinus tachycardia	0/229 (0%)	0	1/118 (0.8%)	1
Other SVT (AVRT, AVNRT, EAT etc.)	10/229 (4.4%)	13	6/118 (5.1%)	9
Premature ventricular contractions (PVC)	3/229 (1.3%)	3	1/118 (0.8%)	1
Hypotension	3/229 (1.3%)	6	0/118 (0%)	0
Hypertension	8/229 (3.5%)	9	4/118 (3.4%)	4
Peripheral vascular disease	2/229 (0.9%)	2	0/118 (0%)	0
Aortic stenosis	1/229 (0.4%)	1	1/118 (0.8%)	1
Mitral regurgitation	2/229 (0.9%)	2	0/118 (0%)	0
Syncope	2/229 (0.9%)	8	4/118 (3.4%)	4
Dizziness	16/229 (7%)	16	4/118 (3.4%)	5
Chest pain - Ischemic	2/229 (0.9%)	2	0/118 (0%)	0
Chest pain - Other	18/229 (7.9%)	24	7/118 (5.9%)	8
Dyspnea	11/229 (4.8%)	11	3/118 (2.5%)	4
Palpitations	8/229 (3.5%)	10	0/118 (0%)	0
Fatigue	5/229 (2.2%)	5	2/118 (1.7%)	2
Multiple symptoms	2/229 (0.9%)	2	7/118 (5.9%)	7
Cerebrovascular accident (CVA)	1/229 (0.4%)	1	0/118 (0%)	0
Deep vein thrombosis (DVT)	2/229 (0.9%)	2	0/118 (0%)	0
Distal thromboemboli	1/229 (0.4%)	1	0/118 (0%)	0
Pericardial effusion - Unrelated to procedure	0/229 (0%)	0	1/118 (0.8%)	1
Hematoma - Unrelated to procedure or device	3/229 (1.3%)	4	0/118 (0%)	0
Other - Patient condition	6/229 (2.6%)	6	5/118 (4.2%)	5
AV Block Intermittent	12/229 (5.2%)	13	0/118 (0%)	0
Endocrine disorders
Endocrine	1/229 (0.4%)	1	2/118 (1.7%)	2
Gastrointestinal disorders
Gastrointestinal	30/229 (13.1%)	35	9/118 (7.6%)	13
General disorders
Other - Patient condition	6/229 (2.6%)	6	6/118 (5.1%)	7
Physical trauma	26/229 (11.4%)	31	7/118 (5.9%)	8
Abnormal laboratory values	6/229 (2.6%)	8	3/118 (2.5%)	4
Head, eyes, ears, nose, throat (HEENT)	36/229 (15.7%)	49	20/118 (16.9%)	28
Adverse Reaction - Allergic	0/229 (0%)	0	11/118 (9.3%)	13
Infections and infestations
Systemic infection	1/229 (0.4%)	2	0/118 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal	27/229 (11.8%)	32	22/118 (18.6%)	35
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	1/229 (0.4%)	1	0/118 (0%)	0
Nervous system disorders
Neurological	19/229 (8.3%)	22	8/118 (6.8%)	10
Product Issues
Oversensing - RA	1/229 (0.4%)	1	0/118 (0%)	0
Undersensing - RA	2/229 (0.9%)	2	1/118 (0.8%)	1
Other - PG system	1/229 (0.4%)	1	1/118 (0.8%)	1
Oversensing - RV	0/229 (0%)	0	1/118 (0.8%)	1
Rate response inappropriate	3/229 (1.3%)	3	0/118 (0%)	0
Inappropriate AV delay	1/229 (0.4%)	2	2/118 (1.7%)	2
Pacemaker-mediated tachycardia (PMT)	6/229 (2.6%)	7	2/118 (1.7%)	2
Hematoma - Pocket (> 30 days post-implant)	0/229 (0%)	0	1/118 (0.8%)	1
Oversensing - RA	2/229 (0.9%)	2	0/118 (0%)	0
Undersensing - RA	1/229 (0.4%)	1	2/118 (1.7%)	2
Extracardiac stimulation - RA	2/229 (0.9%)	2	0/118 (0%)	0
Dislodgment - RA	1/229 (0.4%)	1	0/118 (0%)	0
Other - RA Lead	0/229 (0%)	0	2/118 (1.7%)	2
Oversensing - RV	1/229 (0.4%)	1	0/118 (0%)	0
Undersensing - RV	1/229 (0.4%)	1	0/118 (0%)	0
Elevated threshold - RV	3/229 (1.3%)	3	0/118 (0%)	0
Extracardiac stimulation - RV	1/229 (0.4%)	1	2/118 (1.7%)	2
Extracardiac stimulation - LV	0/229 (0%)	0	1/118 (0.8%)	1
Psychiatric disorders
Psychological	6/229 (2.6%)	6	1/118 (0.8%)	1
Renal and urinary disorders
Renal	6/229 (2.6%)	6	1/118 (0.8%)	1
Reproductive system and breast disorders
Genitourinary	14/229 (6.1%)	14	14/118 (11.9%)	21
Respiratory, thoracic and mediastinal disorders
Pulmonary	11/229 (4.8%)	12	6/118 (5.1%)	6
Skin and subcutaneous tissue disorders
Integumentary	21/229 (9.2%)	25	9/118 (7.6%)	9
Surgical and medical procedures
Post-surgical wound discomfort	5/229 (2.2%)	5	5/118 (4.2%)	6
Post-surgical pocket hemorrhage	1/229 (0.4%)	1	1/118 (0.8%)	1
Post-surgical infection (<= 30 days post-implant)	3/229 (1.3%)	3	1/118 (0.8%)	1
Chest pain	2/229 (0.9%)	2	1/118 (0.8%)	1
Hematoma - Pocket (<=30 days post-implant)	2/229 (0.9%)	2	3/118 (2.5%)	3
Puncture site hematoma - Procedure	1/229 (0.4%)	1	0/118 (0%)	0
Pneumothorax - Procedure	1/229 (0.4%)	1	0/118 (0%)	0
Myocardial perforation without tamponade	0/229 (0%)	0	1/118 (0.8%)	1
Venous occlusion	1/229 (0.4%)	1	0/118 (0%)	0
Other - PG system procedure	0/229 (0%)	0	2/118 (1.7%)	2
Protocol Testing - Adverse reaction - General	2/229 (0.9%)	2	0/118 (0%)	0
Other - Protocol Testing	3/229 (1.3%)	3	0/118 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.