Trial Outcomes & Findings for Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads (NCT NCT02290028)

NCT ID: NCT02290028

Last Updated: 2021-03-24

Results Overview

The purpose of primary endpoint 1 is to evaluate the Sentus QP related complication-free rate through 6 months post-implant. This is evaluated as a percentage of participants without a complication.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2226 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-03-24

Participant Flow

Participant milestones

Measure	Sentus QP Left Ventricular Lead Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D, plus participants that were consented but did not receive a Sentus QP lead or CRT-D.
Overall Study STARTED	2226
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2226

Reasons for withdrawal

Measure	Sentus QP Left Ventricular Lead Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D, plus participants that were consented but did not receive a Sentus QP lead or CRT-D.
Overall Study Death	217
Overall Study Sentus lead or required CRT-D was not implanted	186
Overall Study No longer under care of study physician	76
Overall Study Sentus lead or required CRT-D explanted	55
Overall Study Withdrawal by Subject	52
Overall Study Study site closure	44
Overall Study Lost to Follow-up	34
Overall Study Miscellaneous	10
Overall Study Transition to EP PASSION	1295
Overall Study Planned study completion at 12 months	257

Baseline Characteristics

Data collected and analyzed when available, not all subjects had data available for this measurement

Baseline characteristics by cohort

Measure	Sentus QP Left Ventricular Lead n=2222 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Age, Continuous	68.8 Years STANDARD_DEVIATION 10.8 • n=2221 Participants • Data collected and analyzed when available, not all subjects had data available for this measurement
Sex: Female, Male Female	683 Participants n=2222 Participants
Sex: Female, Male Male	1539 Participants n=2222 Participants
Height	68.0 Inches STANDARD_DEVIATION 4.0 • n=2198 Participants • Data collected and analyzed when available, not all subjects had data available for this measurement
Weight	197.3 Pounds STANDARD_DEVIATION 50.0 • n=2208 Participants • Data collected and analyzed when available, not all subjects had data available for this measurement

PRIMARY outcome

Timeframe: 6 months

Population: All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016.

The purpose of primary endpoint 1 is to evaluate the Sentus QP related complication-free rate through 6 months post-implant. This is evaluated as a percentage of participants without a complication.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=279 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Sentus QP Related Complication-free Rate Through 6 Months	97.1 percentage of participants Interval 94.4 to 98.8	—

PRIMARY outcome

Timeframe: 3 months

Population: All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed threshold testing at 3 months post-implant or with available data from remote monitoring or next visits (as pre-specified in the protocol).

The purpose of primary endpoint 2 is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implant.This was evaluated by performing an exact, binomial test comparing the percentage of participants with acceptable pacing thresholds to a performance goal of 88%. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector are considered acceptable.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=286 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Percentage of Participants With Acceptable Pacing Threshold of Sentus QP Lead in Permanently Programmed Vector at 3 Months	93.4 percentage of participants Interval 89.8 to 96.0	—

PRIMARY outcome

Timeframe: Up to 4 years

Population: All participants in the Post-Market cohort, which included all participants who were enrolled with planned 5 year follow-up and were successfully implanted with a Sentus QP left ventricular lead.

The purpose of primary endpoint 3 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as a percentage of participants without a complication.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=1727 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Sentus QP Related Complication-free Rate	98.03 percentage of participants Interval 97.38 to 98.69	—

SECONDARY outcome

Timeframe: 3 months

Population: All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed threshold testing at 3 months post-implant.

The purpose of the secondary endpoint is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implantation in the two different lead types, Sentus OTW QP L and Sentus OTW QP S. This was evaluated as the number of participants with an acceptable pacing threshold out of the total number of patients for each lead model. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector is considered acceptable.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=240 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead n=36 Participants Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model	226 Participants	32 Participants

SECONDARY outcome

Timeframe: 3 months

Population: All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed novel vector threshold testing at 3 months post-implant.

The purpose of this secondary endpoint is to evaluate the number of participants with at least one acceptable LV lead pacing threshold in a novel pacing vector at 3 months post-implantation. This was evaluated as the number of participants with at least one acceptable LV pacing threshold in a novel pacing vector out of the total number of participants with completed novel pacing threshold testing. LV threshold values of less than or equal to 2.5 V at 0.4 ms in a novel pacing vector is considered acceptable.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=273 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months	261 Participants	—

SECONDARY outcome

Timeframe: 3 months

Population: All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed sensing test at 3 months post-implant.

The purpose of this secondary endpoint is to evaluate acceptable LV lead sensing amplitude at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV sensing amplitude out of the total number of participants. R-wave sensed mean amplitude of greater than or equal to 2 mV is considered acceptable.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=223 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead n=32 Participants Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model	223 Participants	32 Participants

SECONDARY outcome

Timeframe: 3 months

Population: All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed impedance testing at 3 months post-implant.

The purpose of this secondary endpoint is to evaluate the acceptable LV lead pacing impedance at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV pacing impedance out of the total participants. LV impedance values of greater than 200 Ohms and less than 2000 Ohms is considered acceptable.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=245 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead n=36 Participants Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model	245 Participants	36 Participants

SECONDARY outcome

Timeframe: 6 months

Population: All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016.

The purpose of this secondary is to evaluate the Sentus related complication-free rate through 6 months post-implant by the Kaplan-Meier method. The below table shows Kaplan-Meier estimates of the estimated freedom from Sentus related complications at 180 days.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=279 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Sentus QP Time to Complication	97.1 percentage of participants Interval 95.14 to 99.13	—

SECONDARY outcome

Timeframe: Up to 4 years

Population: All participants in the Post-Market cohort, which included all participants who were enrolled with planned 5 year follow-up and were successfully implanted with a Sentus QP left ventricular lead.

The purpose of secondary endpoint 7 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as percentage of participants without a complication per lead model.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=1306 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead n=421 Participants Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Sentus QP Related Complication-free Rate Per Lead Model	98.47 percentage of participants Interval 97.8 to 99.13	96.67 percentage of participants Interval 94.96 to 98.39

SECONDARY outcome

Timeframe: Up to 4 years

Population: All participants in the Post-Market cohort, which included all participants who were enrolled with planned 5 year follow-up and were successfully implanted with a Sentus QP left ventricular lead.

The purpose of secondary endpoint 8 is to evaluate the rate of individual types of adverse events related to the Sentus QP lead through study termination (post approval phase). This is evaluated as the percentage of participants with a specific adverse event out of the total participants.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=1727 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Individual Sentus QP Adverse Event Rates Dislodgements	1.39 percentage of participants Interval 0.08 to 1.94	—
Individual Sentus QP Adverse Event Rates Extracardiac Stimulation	0.17 percentage of participants Interval 0.04 to 0.51	—
Individual Sentus QP Adverse Event Rates Mechanical Lead Failure	0.12 percentage of participants Interval 0.01 to 0.42	—
Individual Sentus QP Adverse Event Rates Elevated Lead Impedance	0.12 percentage of participants Interval 0.01 to 0.42	—
Individual Sentus QP Adverse Event Rates Elevated LV Pacing Threshold	0.06 percentage of participants Interval 0.0 to 0.32	—
Individual Sentus QP Adverse Event Rates Electrical Lead Failure	0.06 percentage of participants Interval 0.0 to 0.32	—
Individual Sentus QP Adverse Event Rates Cardiac Perforation	0.06 percentage of participants Interval 0.0 to 0.32	—

SECONDARY outcome

Timeframe: 12 months

Population: All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and whom experienced phrenic nerve stimulation or high LV pacing threshold.

The purpose of this secondary endpoint is to evaluate the number of participants in whom phrenic nerve stimulation or high LV pacing threshold was be successfully resolved by reprogramming of the LV pacing vector. This is evaluated as the number of participants with successful reprogramming out of all participants experiencing phrenic nerve stimulation or high LV pacing threshold. LV pacing threshold resulting in invasive intervention, or, in the absence of intervention, a lead threshold that has increased two fold from the chronic threshold value, and is unable to achieve a 2:1 safety margin at follow-up is considered a high LV pacing threshold.

Outcome measures

Measure	Sentus QP Left Ventricular Lead n=97 Participants Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.	Sentus QP S Model Left Ventricular Lead Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold	73 Participants	—

Adverse Events

Sentus QP Left Ventricular Lead

Serious events: 290 serious events

Other events: 711 other events

Deaths: 217 deaths

Serious adverse events

Measure	Sentus QP Left Ventricular Lead n=2226 participants at risk Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Cardiac disorders Cardiac perforation associated with the RA lead	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders Cardiac perforation associated with the RV lead	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders Cardiac perforation associated with the LV lead	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders Inability to place LV lead	0.18% 4/2226 • Number of events 4 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RA lead related lead dislodgement	1.4% 31/2226 • Number of events 31 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RV lead related lead dislodgement	0.99% 22/2226 • Number of events 23 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RV lead related elevated pacing threshold	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RV lead impedance out of range, high impedance	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RV lead related clinical failure	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RV lead related mechanical failure	0.09% 2/2226 • Number of events 2 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RV lead undersensing or loss of sensing	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders Endocarditis associated with the RV lead	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related lead dislodgement	2.7% 59/2226 • Number of events 66 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related extracardiac stimulation	0.49% 11/2226 • Number of events 11 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related mechanical failure	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related high pacing threshold	0.09% 2/2226 • Number of events 2 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related elevated pacing threshold	0.09% 2/2226 • Number of events 2 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related clinical failure	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related loss of capture	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders ICD device migration	0.18% 4/2226 • Number of events 4 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders ICD device related inappropriate shock or ATP	0.36% 8/2226 • Number of events 8 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders ICD device related electronic failure	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
General disorders Twiddler's syndrome	0.27% 6/2226 • Number of events 6 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Infections and infestations Implant procedure related infection	1.0% 23/2226 • Number of events 24 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Infections and infestations Secondary infection	0.45% 10/2226 • Number of events 10 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Infections and infestations Pocket infection	0.27% 6/2226 • Number of events 6 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Cardiac perforation	0.13% 3/2226 • Number of events 4 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Arrhythmia associated with implant procedure	0.31% 7/2226 • Number of events 7 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Hematoma	0.76% 17/2226 • Number of events 17 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Loose set-screw	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Pneumothorax	0.72% 16/2226 • Number of events 16 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Pericarditis	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Pleural effusion	0.18% 4/2226 • Number of events 4 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Pericardial effusion	0.09% 2/2226 • Number of events 2 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Respiratory arrest	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Stroke	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Cardiogenic shock	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Respiratory distress	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Renal failure	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Wound healing disturbance	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Venous occlusion	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Discomfort/pain	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Post surgical bleeding	0.22% 5/2226 • Number of events 5 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Post procedure anemia	0.09% 2/2226 • Number of events 2 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Allergy to contrast agent	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Elevated WBD and labs post procedure	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Inflammation and swelling at surgical site	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RA lead elevated pacing threshold	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead electrical lead failure	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead impedance out of range, high	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.

Other adverse events

Measure	Sentus QP Left Ventricular Lead n=2226 participants at risk Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Cardiac disorders Inability to place LV lead	4.5% 101/2226 • Number of events 101 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RA lead related lead dislodgement	0.31% 7/2226 • Number of events 7 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RA lead related undersensing	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RV lead related clinical failure	0.09% 2/2226 • Number of events 2 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RV lead related extracardiac stimulation	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RV lead related high pacing threshold	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RV lead related oversensing	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related extracardiac stimulation	11.6% 258/2226 • Number of events 316 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related elevated pacing threshold	5.9% 132/2226 • Number of events 147 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related lead dislodgement	1.2% 27/2226 • Number of events 29 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related loss of capture	1.1% 24/2226 • Number of events 26 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead impedance out of range, high impedance	0.85% 19/2226 • Number of events 20 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related high pacing threshold	1.7% 38/2226 • Number of events 40 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related clinical failure	0.31% 7/2226 • Number of events 7 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related oversensing	0.18% 4/2226 • Number of events 4 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related mechanical failure	0.09% 2/2226 • Number of events 2 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related electrical failure	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders LV lead related loss of sensing	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders ICD device migration	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders ICD device related inappropriate shock or ATP	0.27% 6/2226 • Number of events 6 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders ICD device related housing defect	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders ICD device related high defibrillator (DFT) testing	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders ICD device related pacemaker mediated tachycardia (PMT)	0.09% 2/2226 • Number of events 2 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
General disorders Twiddler's syndrome	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
General disorders Rachet syndrome	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Infections and infestations Implant procedure related infection	0.36% 8/2226 • Number of events 8 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Arrhythmia associated with implant procedure	0.22% 5/2226 • Number of events 5 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Hematoma	0.54% 12/2226 • Number of events 13 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Coronary sinus dissection	0.40% 9/2226 • Number of events 10 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Loose set-screw	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Pneumothorax	0.13% 3/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Pericardial effusion	0.18% 4/2226 • Number of events 4 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Pleural effusion	0.18% 4/2226 • Number of events 4 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Bleeding at surgical site	0.31% 7/2226 • Number of events 7 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Allergy to surgery prep	0.27% 6/2226 • Number of events 6 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Unsuccessful defibrillator threshold (DFT) testing	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Wound healing disturbance	0.22% 5/2226 • Number of events 5 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Venous occlusion	0.27% 6/2226 • Number of events 6 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Discomfort/pain at surgical site	0.63% 14/2226 • Number of events 14 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RA lead elevated pacing threshold	0.13% 3/2226 • Number of events 4 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RA lead related extracardiac stimulation	0.09% 2/2226 • Number of events 3 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Cardiac disorders RA lead related thrombosis	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Pain in shoulder after system revision	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Hypotension after insertion procedure	0.09% 2/2226 • Number of events 2 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Bleeding caused by surgical prep	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Fever after insertion procedure	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Surgical and medical procedures Emesis after insertion procedure	0.04% 1/2226 • Number of events 1 • Though study exit or study termination, an average of 1.2 years, and up to 4 years According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.

Additional Information

Senior Manager, Scientific Affairs

BIOTRONIK, Inc.

Phone: 1-800-547-0394

Email: crystal.miller@biotronik.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place