Trial Outcomes & Findings for Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead (NCT NCT01576016)

NCT ID: NCT01576016

Last Updated: 2020-11-10

Results Overview

Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit

Recruitment status

COMPLETED

Study phase

Target enrollment

950 participants

Primary outcome timeframe

Implant through 2 months

Results posted on

2020-11-10

Participant Flow

Lead safety phase: enrollment began on 03-30-2012 and ended on 06-18-2013; enrollment occured at 68 sites and 920 patients were enrolled. MRI Phase: study was approved by FDA on 03-26-2014. 255 patients were enrolled into the MRI Phase. 181 scans were completed by the 10-30-2014 cut-off date: 151 in the US, and 30 supplemental scans in Australia. The patients enrolled in the US came from the lead safety phase, the supplemental scans in Australia did not participate in lead safety phase.

The MRI phase was originally designed as a randomized study, with MRI and control groups, but due to challenges encountered with patient recruitment, it was later changed to a non-randomized study.

Participant milestones

Participant milestones
Measure	Lead Safety Phase Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.	MRI Safety Phase A subset of patients enrolled in the Lead safety phase underwent an elective MRI scan to evaluate the safety and efficacy of Accent MRI system within the MRI environment.
Lead Safety STARTED	920	0
Lead Safety COMPLETED	647	0
Lead Safety NOT COMPLETED	273	0
MRI Safety STARTED	0	255
MRI Safety COMPLETED	0	181
MRI Safety NOT COMPLETED	0	74

Reasons for withdrawal

Reasons for withdrawal
Measure	Lead Safety Phase Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.	MRI Safety Phase A subset of patients enrolled in the Lead safety phase underwent an elective MRI scan to evaluate the safety and efficacy of Accent MRI system within the MRI environment.
Lead Safety Death	132	0
Lead Safety Withdrawal by Subject	81	0
Lead Safety System Explanted without Replacement	24	0
Lead Safety Physician Decision	14	0
Lead Safety Lost to Follow-up	13	0
Lead Safety Unsuccessful implant	2	0
Lead Safety Sponsor request	1	0
Lead Safety Device replaced with CRT-D	1	0
Lead Safety Patient on Palliative Care	1	0
Lead Safety Patient noncompliance	1	0
Lead Safety Too far from study site	1	0
Lead Safety System deactivated	1	0
Lead Safety Patient no longer followed by study PI	1	0
MRI Safety Withdrawal by Subject	0	10
MRI Safety Non-MRI Compatible Device or Material	0	5
MRI Safety Has not yet completed MRI scan	0	56
MRI Safety MRI scan not performed at MRI visit	0	3

Baseline Characteristics

Each phase was analyzed separately.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Implant through 2 months

Population: 99 of the 920 enrolled subjects had no RA lead and hence did not contribute any data towards this endpoint.

Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=821 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period	97.2 percentage of subjects Interval 95.81 to 98.13

PRIMARY outcome

Timeframe: Implant through 2 months

Population: one of 920 enrolled subjects did not have an RV lead implanted.

Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=919 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period	98.45 percentage of subjects Interval 96.81 to 99.25

PRIMARY outcome

Timeframe: 2 months through 12 months

Population: Data from 114 subjects were unavailable for this endpoint analysis due to the following reasons: no RA lead: 99; death: 8; unsuccessful implant: 2; withdrawal:5.

Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=806 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Freedom From RA Related Complications in the Chronic Period	98.82 percentage of subjects Interval 97.04 to 99.53

PRIMARY outcome

Timeframe: 2 months through 12 months

Population: Data from 18 subjects were unavailable for this endpoint analysis due to the following reasons: no RV lead: 1; death: 9; unsuccessful implant: 2; withdrawal: 6.

Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=902 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Freedom From Right Ventricular Lead Related Complications in the Chronic Period	100 percentage of subjects Interval 100.0 to 100.0

PRIMARY outcome

Timeframe: MRI Scan visit through 1 month after MRI scan visit

Population: 151 of the 255 patients enrolled received an MRI scan. An additional 30 scans were performed using an identical scan protocol implemented in this study, for a total of 181 patients who underwent an MRI scan.

Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=181 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Freedom From MRI Scan-related Complications	100 percentage of subjects Interval 98.37 to 100.0

PRIMARY outcome

Timeframe: MRI Scan visit to 1 month after MRI scan visit

Population: 37 of the 181 subjects that underwent a MRI scan did not have RA capture threshold data at 1-month post scan; no RA lead: 10; RA lead off: 3; atrial fibrillation (AF/AFl) during measurement: 10; 1-month visit not completed: 14.

Percentage of patients with an increase in RA capture thresholds of \<= 0.5 V, at a pulse width of 0.5 ms .

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=144 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Change in Atrial Capture Threshold From Pre to Post MRI Scan	100 percentage of subjects Interval 97.47 to 100.0

PRIMARY outcome

Timeframe: MRI Scan visit to 1 month after MRI scan visit

Population: 167 of the 181 subjects with an MRI scan had completed the 1-month post MRI visit. Data from 167 subjects was available for this analysis; 13 subjects had not completed 1 month follow-up, 1 subject had RV capture threshold missing or not done.

Percentage of patients with an increase in RV capture thresholds of \<=0.5V, at a pulse width of 0.5 ms.

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=167 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Change in Ventricular Capture Threshold Pre to Post MRI Scan	100 percentage of subjects Interval 97.82 to 100.0

PRIMARY outcome

Timeframe: MRI Scan visit to 1 month after MRI scan visit

Population: 60 of the 181 subjects that underwent an MRI scan did not have RA sense amplitude data: no RA lead: 10; RA lead off: 3; AF/AFl/ heart rate\< 30 bpm/ no P-wave during measurement: 11; P-wave \< 1.5 mV: 23; 1-month visit not yet completed: 12; AF/AFl during 1-month measurement: 1

Percentage of patients with a reduction in RA sense amplitude \<=50 % and sense amplitude \>=1.5 mV.

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=121 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Change in Atrial Sense Amplitude	92.56 percentage of subjects Interval 86.35 to 96.54

PRIMARY outcome

Timeframe: MRI Scan visit to 1 month after the MRI Scan visit

Population: 47 of 181 subjects that underwent an MRI scan did not have RV sense amplitude: no R-wave/HR \< 30 beats per minute (BPM): 18; R-wave amplitude \< 5 mV: 18; one-month visit not completed: 11. 134 subjects were available for evaluation of endpoint.

Percentage of patients with an reduction in RV sense amplitude \<=50% and sense amplitude \>=5 mV.

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=134 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Change in Ventricular Sense Amplitude	97.76 percentage of subjects Interval 93.6 to 99.5

SECONDARY outcome

Timeframe: Implant through 12 months

Population: All subjects enrolled in the lead-safety arm.

Percentage of patients who do not have system-related complications from implant through the 12 month study visit

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=920 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Freedom From System-related Complications	94.64 percentage of subjects Interval 92.76 to 96.05

SECONDARY outcome

Timeframe: MRI Scan visit (approx 3 months post implant)

Population: 23 of the 181 subjects that underwent an MRI scan did not have RA capture threshold for the MRI scan visit: no RA lead: 10; RA lead off: 3; AF/AFl during measurement: 10.

Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=158 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Atrial Capture Threshold at the MRI Visit	100.00 percentage of subjects Interval 97.69 to 100.0

SECONDARY outcome

Timeframe: MRI Scan visit (approx 3 months post implant)

Population: All subjects that underwent a MRI scan had ventricular capture threshold data available.

Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit

Outcome measures

Outcome measures
Measure	Lead Safety Phase n=181 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.
Ventricular Capture Threshold at the MRI Visit	100.00 percentage of subjects Interval 97.98 to 100.0

Adverse Events

Lead Safety Phase

Serious events: 70 serious events

Other events: 60 other events

Deaths: 132 deaths

MRI Phase

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Lead Safety Phase n=920 participants at risk Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.	MRI Phase n=255 participants at risk Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker, within the MRI environment.
Product Issues RA Lead Related: Oversensing	0.76% 7/920 • Number of events 7 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
General disorders Pacemaker Related: Pacemaker Mediated Tachycardia	3.3% 30/920 • Number of events 32 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.39% 1/255 • Number of events 1 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
Injury, poisoning and procedural complications Procedure Related: Bleeding/Hematoma	0.98% 9/920 • Number of events 9 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
Injury, poisoning and procedural complications Procedure Related: Pneumothorax	0.76% 7/920 • Number of events 7 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
Vascular disorders Procedure Related: Thrombo-Embolic Event	0.76% 7/920 • Number of events 7 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
Cardiac disorders ORE: Atrial Arrhythmia	5.0% 46/920 • Number of events 56 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
Cardiac disorders ORE: Decompensated HF	1.8% 17/920 • Number of events 22 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
Cardiac disorders ORE: Ventricular Arrhythmia	1.5% 14/920 • Number of events 16 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
Cardiac disorders ORE: Chest Pain	0.76% 7/920 • Number of events 8 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
Vascular disorders ORE: Cerebrovascular Accident	0.87% 8/920 • Number of events 9 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
Cardiac disorders ORE: Angina	0.76% 7/920 • Number of events 10 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
Cardiac disorders ORE: Syncope	0.54% 5/920 • Number of events 6 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.	0.00% 0/255 • 5 years Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study. Complications: AEs that require invasive intervention. Observations: AEs that can be managed without invasive intervention. Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.

Additional Information

Grant Kim, Program Director - Traditional Cardiac Rhythm Management

Abbott

Phone: 818-493-3147

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Lead Safety Phase n=920 Participants Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRI™ lead and Accent MRI™ pacemaker.	MRI Phase n=255 Participants A subset of patients enrolled in the Lead safety phase (225 subjects from lead safety phase) underwent an elective MRI scan to evaluate the safety and efficacy of Accent MRI system within the MRI environment.	Total n=1175 Participants Total of all reporting groups
Age, Continuous Age - Lead Safety Phase	73.5 years STANDARD_DEVIATION 10.8 • n=920 Participants • Each phase was analyzed separately.	—	73.5 years STANDARD_DEVIATION 10.8 • n=920 Participants • Each phase was analyzed separately.
Age, Continuous Age - MRI Safety Phase	—	70.2 years STANDARD_DEVIATION 11.6 • n=255 Participants • Each phase was analyzed separately.	70.2 years STANDARD_DEVIATION 11.6 • n=255 Participants • Each phase was analyzed separately.
Sex: Female, Male Sex - Lead Safety Phase · Female	421 Participants n=920 Participants • Each phase was analyzed separately.	—	421 Participants n=920 Participants • Each phase was analyzed separately.
Sex: Female, Male Sex - Lead Safety Phase · Male	499 Participants n=920 Participants • Each phase was analyzed separately.	—	499 Participants n=920 Participants • Each phase was analyzed separately.
Sex: Female, Male Sex - MRI Safety Phase · Female	—	114 Participants n=255 Participants • Each phase was analyzed separately.	114 Participants n=255 Participants • Each phase was analyzed separately.
Sex: Female, Male Sex - MRI Safety Phase · Male	—	141 Participants n=255 Participants • Each phase was analyzed separately.	141 Participants n=255 Participants • Each phase was analyzed separately.
Ethnicity (NIH/OMB) Lead Safety Phase · Hispanic or Latino	14 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants Analysis for lead safety and MRI safety phases was done separately.	14 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.
Ethnicity (NIH/OMB) Lead Safety Phase · Not Hispanic or Latino	904 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants Analysis for lead safety and MRI safety phases was done separately.	904 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.
Ethnicity (NIH/OMB) Lead Safety Phase · Unknown or Not Reported	2 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants Analysis for lead safety and MRI safety phases was done separately.	2 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.
Ethnicity (NIH/OMB) MRI Safety Phase · Hispanic or Latino	0 Participants Analysis for lead safety and MRI safety phases was done separately.	4 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.	4 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.
Ethnicity (NIH/OMB) MRI Safety Phase · Not Hispanic or Latino	0 Participants Analysis for lead safety and MRI safety phases was done separately.	251 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.	251 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.
Ethnicity (NIH/OMB) MRI Safety Phase · Unknown or Not Reported	0 Participants Analysis for lead safety and MRI safety phases was done separately.	0 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) Lead Safety Phase · American Indian or Alaska Native	3 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants Analysis for lead safety and MRI safety phases was done separately.	3 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) Lead Safety Phase · Asian	12 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants Analysis for lead safety and MRI safety phases was done separately.	12 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) Lead Safety Phase · Native Hawaiian or Other Pacific Islander	2 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants Analysis for lead safety and MRI safety phases was done separately.	2 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) Lead Safety Phase · Black or African American	51 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants Analysis for lead safety and MRI safety phases was done separately.	51 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) Lead Safety Phase · White	842 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants Analysis for lead safety and MRI safety phases was done separately.	842 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) Lead Safety Phase · More than one race	0 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants Analysis for lead safety and MRI safety phases was done separately.	0 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) Lead Safety Phase · Unknown or Not Reported	10 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants Analysis for lead safety and MRI safety phases was done separately.	10 Participants n=920 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) MRI Safety Phase · American Indian or Alaska Native	0 Participants Analysis for lead safety and MRI safety phases was done separately.	1 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.	1 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) MRI Safety Phase · Asian	0 Participants Analysis for lead safety and MRI safety phases was done separately.	2 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.	2 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) MRI Safety Phase · Native Hawaiian or Other Pacific Islander	0 Participants Analysis for lead safety and MRI safety phases was done separately.	1 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.	1 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) MRI Safety Phase · Black or African American	0 Participants Analysis for lead safety and MRI safety phases was done separately.	20 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.	20 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) MRI Safety Phase · White	0 Participants Analysis for lead safety and MRI safety phases was done separately.	229 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.	229 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) MRI Safety Phase · More than one race	0 Participants Analysis for lead safety and MRI safety phases was done separately.	0 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.	0 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.
Race (NIH/OMB) MRI Safety Phase · Unknown or Not Reported	0 Participants Analysis for lead safety and MRI safety phases was done separately.	2 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.	2 Participants n=255 Participants • Analysis for lead safety and MRI safety phases was done separately.
Region of Enrollment United States	920 participants n=920 Participants • Region of enrollment for lead safety phase only. Each phase of the study was analyzed separately	225 participants n=225 Participants • Region of enrollment for MRI safety phase only. Each phase of the study was analyzed separately	225 participants n=225 Participants • Region of enrollment for MRI safety phase only. Each phase of the study was analyzed separately
Region of Enrollment Australia	—	30 participants n=30 Participants • Region of enrollment for MRI safety phase only. Each phase of the study was analyzed separately	30 participants n=30 Participants • Region of enrollment for MRI safety phase only. Each phase of the study was analyzed separately
Primary Indication for Pacemaker Implant Lead Safety Phase · AV block	246 Participants n=920 Participants • Each phase was analyzed separately.	—	246 Participants n=920 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant Lead Safety Phase · Other	19 Participants n=920 Participants • Each phase was analyzed separately.	—	19 Participants n=920 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant Lead Safety Phase · Pacemaker Generator Change	2 Participants n=920 Participants • Each phase was analyzed separately.	—	2 Participants n=920 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant Lead Safety Phase · Prevention/Termination Of Tachyarrhythmias By Paci	13 Participants n=920 Participants • Each phase was analyzed separately.	—	13 Participants n=920 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant Lead Safety Phase · Sinus Node Dysfunction	581 Participants n=920 Participants • Each phase was analyzed separately.	—	581 Participants n=920 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant Lead Safety Phase · Syncope	59 Participants n=920 Participants • Each phase was analyzed separately.	—	59 Participants n=920 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant MRI Safety Phase · AV block	—	65 Participants n=255 Participants • Each phase was analyzed separately.	65 Participants n=255 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant MRI Safety Phase · Other	—	7 Participants n=255 Participants • Each phase was analyzed separately.	7 Participants n=255 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant MRI Safety Phase · Pacemaker Generator Change	—	1 Participants n=255 Participants • Each phase was analyzed separately.	1 Participants n=255 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant MRI Safety Phase · Prevention/Termination Of Tachyarrhythmias By Paci	—	5 Participants n=255 Participants • Each phase was analyzed separately.	5 Participants n=255 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant MRI Safety Phase · Sinus Node Dysfunction	—	159 Participants n=255 Participants • Each phase was analyzed separately.	159 Participants n=255 Participants • Each phase was analyzed separately.
Primary Indication for Pacemaker Implant MRI Safety Phase · Syncope	—	18 Participants n=255 Participants • Each phase was analyzed separately.	18 Participants n=255 Participants • Each phase was analyzed separately.
Cardiovascular History Lead Safety Phase · Coronary Artery Disease	338 Participants n=920 Participants • Each phase was analyzed separately	—	338 Participants n=920 Participants • Each phase was analyzed separately
Cardiovascular History Lead Safety Phase · Myocardial Infarction	119 Participants n=920 Participants • Each phase was analyzed separately	—	119 Participants n=920 Participants • Each phase was analyzed separately
Cardiovascular History Lead Safety Phase · Unstable Angina	73 Participants n=920 Participants • Each phase was analyzed separately	—	73 Participants n=920 Participants • Each phase was analyzed separately
Cardiovascular History Lead Safety Phase · None	390 Participants n=920 Participants • Each phase was analyzed separately	—	390 Participants n=920 Participants • Each phase was analyzed separately
Cardiovascular History MRI Safety Phase · Coronary Artery Disease	—	35 Participants n=255 Participants • Each phase was analyzed separately	35 Participants n=255 Participants • Each phase was analyzed separately
Cardiovascular History MRI Safety Phase · Myocardial Infarction	—	5 Participants n=255 Participants • Each phase was analyzed separately	5 Participants n=255 Participants • Each phase was analyzed separately
Cardiovascular History MRI Safety Phase · Unstable Angina	—	6 Participants n=255 Participants • Each phase was analyzed separately	6 Participants n=255 Participants • Each phase was analyzed separately
Cardiovascular History MRI Safety Phase · None	—	209 Participants n=255 Participants • Each phase was analyzed separately	209 Participants n=255 Participants • Each phase was analyzed separately
Prior Cardiac Interventions Lead Safety Phase · Ablation	100 Participants n=920 Participants • Each phase was analyzed separately	—	100 Participants n=920 Participants • Each phase was analyzed separately
Prior Cardiac Interventions Lead Safety Phase · Coronary Artery Bypass Graft	130 Participants n=920 Participants • Each phase was analyzed separately	—	130 Participants n=920 Participants • Each phase was analyzed separately
Prior Cardiac Interventions Lead Safety Phase · PTCA/Stents/Atherectomy	152 Participants n=920 Participants • Each phase was analyzed separately	—	152 Participants n=920 Participants • Each phase was analyzed separately
Prior Cardiac Interventions Lead Safety Phase · None	538 Participants n=920 Participants • Each phase was analyzed separately	—	538 Participants n=920 Participants • Each phase was analyzed separately
Prior Cardiac Interventions MRI Safety Phase · Ablation	—	38 Participants n=255 Participants • Each phase was analyzed separately	38 Participants n=255 Participants • Each phase was analyzed separately
Prior Cardiac Interventions MRI Safety Phase · Coronary Artery Bypass Graft	—	2 Participants n=255 Participants • Each phase was analyzed separately	2 Participants n=255 Participants • Each phase was analyzed separately
Prior Cardiac Interventions MRI Safety Phase · PTCA/Stents/Atherectomy	—	8 Participants n=255 Participants • Each phase was analyzed separately	8 Participants n=255 Participants • Each phase was analyzed separately
Prior Cardiac Interventions MRI Safety Phase · None	—	207 Participants n=255 Participants • Each phase was analyzed separately	207 Participants n=255 Participants • Each phase was analyzed separately
Non-Ventricular Arrhythmia History Paroxysmal AF - lead safety	316 participants n=920 Participants	0 participants n=255 Participants	316 participants n=1175 Participants
Non-Ventricular Arrhythmia History Paroxysmal AF - MRI safety	0 participants n=920 Participants	79 participants n=255 Participants	79 participants n=1175 Participants
Non-Ventricular Arrhythmia History Permanent AF - lead safety	63 participants n=920 Participants	0 participants n=255 Participants	63 participants n=1175 Participants
Non-Ventricular Arrhythmia History Permanent AF - MRI safety	0 participants n=920 Participants	16 participants n=255 Participants	16 participants n=1175 Participants
Non-Ventricular Arrhythmia History Persistent AF - lead safety	100 participants n=920 Participants	0 participants n=255 Participants	100 participants n=1175 Participants
Non-Ventricular Arrhythmia History Persistent AF - MRI safety	0 participants n=920 Participants	23 participants n=255 Participants	23 participants n=1175 Participants
Non-Ventricular Arrhythmia History Atrial Flutter - lead safety	123 participants n=920 Participants	0 participants n=255 Participants	123 participants n=1175 Participants
Non-Ventricular Arrhythmia History Atrial Flutter - MRI safety	0 participants n=920 Participants	39 participants n=255 Participants	39 participants n=1175 Participants
Non-Ventricular Arrhythmia History Atrial Tachycardia - lead safety	41 participants n=920 Participants	0 participants n=255 Participants	41 participants n=1175 Participants
Non-Ventricular Arrhythmia History Atrial Tachycardia - MRI safety	0 participants n=920 Participants	16 participants n=255 Participants	16 participants n=1175 Participants
Non-Ventricular Arrhythmia History Supra Ventricular - lead safety	55 participants n=920 Participants	0 participants n=255 Participants	55 participants n=1175 Participants
Non-Ventricular Arrhythmia History Supra Ventricular - MRI safety	0 participants n=920 Participants	10 participants n=255 Participants	10 participants n=1175 Participants
Non-Ventricular Arrhythmia History None - lead safety	370 participants n=920 Participants	0 participants n=255 Participants	370 participants n=1175 Participants
Non-Ventricular Arrhythmia History None - MRI safety	0 participants n=920 Participants	111 participants n=255 Participants	111 participants n=1175 Participants