Trial Outcomes & Findings for St.Jude Medical Cardiac Lead Assessment Study (NCT NCT01507987)

NCT ID: NCT01507987

Last Updated: 2021-08-23

Results Overview

The prevalence of electrical dysfunction was calculated as the number of leads that have electrical dysfunction through three years of follow-up for the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups.

• Recruitment status: COMPLETED
• Target enrollment: 2216 participants
• Primary outcome timeframe: This outcome is assessed at enrollment and over the course of 3 years of follow-up
• Results posted on: 2021-08-23

Participant Flow

The study enrolled a total of 2,216 subjects at 45 sites to achieve an evaluable sample size of at least 1,401 subjects. The first subject enrolled in this study on March 20, 2013 and enrollment was completed in June, 2016 with the last follow-up completed in June 13 2019.

A subject that has at least one market released lead implanted was eligible for enrollment in the study. Subjects could have more than one study lead implanted. Each lead group was considered separately for independent analyses.

Unit of analysis: implants

Participant milestones

Measure	Durata Leads Durata leads implanted between 2008-2010	Riata Leads Riata leads implanted between 2002-2009	Riata ST Riata ST leads implanted 2006-2009	QuickSite/QuickFlex QuickSite/QuickFlex implanted 2006-2010
Overall Study STARTED	982 982	670 670	458 458	737 737
Overall Study COMPLETED	618 618	335 335	252 252	480 480
Overall Study NOT COMPLETED	364 364	335 335	206 206	257 257

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

St.Jude Medical Cardiac Lead Assessment Study

Baseline characteristics by cohort

Measure	All Subjects Enrolled in the Study n=2216 Participants Demographics for all enrolled patients (N=2216)
Age, Continuous	67 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	600 Participants n=5 Participants
Sex: Female, Male Male	1616 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2158 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=5 Participants
Race (NIH/OMB) Asian	91 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	335 Participants n=5 Participants
Race (NIH/OMB) White	1770 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment Canada	48 participants n=5 Participants
Region of Enrollment United States	2085 participants n=5 Participants
Region of Enrollment Japan	83 participants n=5 Participants

PRIMARY outcome

Timeframe: This outcome is assessed at enrollment and over the course of 3 years of follow-up

Population: All SJM leads enrolled in the study with Durata, Riata, Riata ST, or QuickSite/QuickFlex leads

The prevalence of electrical dysfunction was calculated as the number of leads that have electrical dysfunction through three years of follow-up for the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups.

Outcome measures

Measure	Durata Leads n=982 implanted leads Durata leads implanted between 2008-2010	Riata Leads n=670 implanted leads Riata leads implanted between 2002-2009	Riata ST n=458 implanted leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=737 implanted leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
Number of Leads With Electrical Dysfunction	24 implanted leads	27 implanted leads	15 implanted leads	2 implanted leads	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: This outcome is assessed at enrollment

Population: All SJM leads enrolled in the study with Durata, Riata, Riata ST, or QuickSite/QuickFlex leads

The prevalence of externalized conductors was calculated as the number of leads that have been shown to have externalized conductors by imaging at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups

Outcome measures

Measure	Durata Leads n=973 implanted leads Durata leads implanted between 2008-2010	Riata Leads n=660 implanted leads Riata leads implanted between 2002-2009	Riata ST n=452 implanted leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=723 implanted leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
Number of Leads With Externalized Conductors	0 implanted leads	144 implanted leads	44 implanted leads	10 implanted leads	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: This outcome is assessed at enrollment

The prevalence of other visual lead anomalies (by each subcategory) was calculated as the number of leads that have been shown to have other visual anomaly (by each subcategory) at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups.

Outcome measures

Measure	Durata Leads n=974 implanted leads Durata leads implanted between 2008-2010	Riata Leads n=646 implanted leads Riata leads implanted between 2002-2009	Riata ST n=454 implanted leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=724 implanted leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)	7 implanted leads	19 implanted leads	7 implanted leads	4 implanted leads	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: This outcome is assessed from enrollment through the course of 3 years of follow-up

Population: The annual hazard rate was assessed separately in each of the 4 lead groups.

Annual hazard rate is the proportion of number of leads with electrical dysfunction to the total number of lead follow-up years.

Outcome measures

Measure	Durata Leads n=982 implanted leads Durata leads implanted between 2008-2010	Riata Leads n=670 implanted leads Riata leads implanted between 2002-2009	Riata ST n=458 implanted leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=737 implanted leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.	0.010 leads with electrical dysfunction/years	0.019 leads with electrical dysfunction/years	0.014 leads with electrical dysfunction/years	0.001 leads with electrical dysfunction/years	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: year 1 follow-up

Population: The annual hazard rate was assessed separately in each of the 4 lead groups.

Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from enrollment to year 1

Outcome measures

Measure	Durata Leads n=808 implanted leads Durata leads implanted between 2008-2010	Riata Leads n=375 implanted leads Riata leads implanted between 2002-2009	Riata ST n=316 implanted leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=556 implanted leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
The Annual Hazard Rate of New Cases of Externalized Conductors (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.	0.0025 leads with externalized conductors/years Interval 0.0003 to 0.0089	0.0480 leads with externalized conductors/years Interval 0.0287 to 0.0748	0.0158 leads with externalized conductors/years Interval 0.0052 to 0.0365	0.0288 leads with externalized conductors/years Interval 0.0165 to 0.0463	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: year 1 to year 2 follow-up

Population: The annual hazard rate was assessed separately in each of the 4 lead groups.

Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 1 to year 2

Outcome measures

Measure	Durata Leads n=687 implanted leads Durata leads implanted between 2008-2010	Riata Leads n=301 implanted leads Riata leads implanted between 2002-2009	Riata ST n=256 implanted leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=462 implanted leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.	0.0015 leads with externalized conductors/years Interval 0.0 to 0.0081	0.0897 leads with externalized conductors/years Interval 0.0599 to 0.1278	0.0234 leads with externalized conductors/years Interval 0.0086 to 0.0503	0.0087 leads with externalized conductors/years Interval 0.0024 to 0.022	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: year 2 to year 3 follow-up

Population: The annual hazard rate was assessed separately in each of the 4 lead groups.

Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 2 to year 3

Outcome measures

Measure	Durata Leads n=570 implanted leads Durata leads implanted between 2008-2010	Riata Leads n=228 implanted leads Riata leads implanted between 2002-2009	Riata ST n=206 implanted leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=362 implanted leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.	0.0035 leads with externalized conductors/years Interval 0.0004 to 0.0126	0.0658 leads with externalized conductors/years Interval 0.0373 to 0.1062	0.0097 leads with externalized conductors/years Interval 0.0012 to 0.0346	0.0110 leads with externalized conductors/years Interval 0.003 to 0.028	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: This outcome is assessed from enrollment to year 1

Population: The annual hazard rate was assessed separately in each of the 4 lead groups.

Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from enrollment to year 1

Outcome measures

Measure	Durata Leads n=803 implanted leads Durata leads implanted between 2008-2010	Riata Leads n=461 implanted leads Riata leads implanted between 2002-2009	Riata ST n=343 implanted leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=571 implanted leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads	0.0025 leads w other visual lead anomaly/years Interval 0.0003 to 0.009	0.0108 leads w other visual lead anomaly/years Interval 0.0035 to 0.0251	0.0117 leads w other visual lead anomaly/years Interval 0.0032 to 0.0296	0.0053 leads w other visual lead anomaly/years Interval 0.0011 to 0.0153	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: This outcome is assessed from year 1 to year 2 of follow-up

Population: The annual hazard rate was assessed separately in each of the 4 lead groups.

Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 1 to year 2

Outcome measures

Measure	Durata Leads n=254 implanted leads Durata leads implanted between 2008-2010	Riata Leads n=374 implanted leads Riata leads implanted between 2002-2009	Riata ST n=286 implanted leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=482 implanted leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads	0 leads w other visual lead anomaly/years Interval 0.0 to 0.0054	0.0027 leads w other visual lead anomaly/years Interval 0.0001 to 0.0148	0.0070 leads w other visual lead anomaly/years Interval 0.0008 to 0.025	0.0021 leads w other visual lead anomaly/years Interval 0.0001 to 0.0115	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: This outcome is assessed from year 2 to year 3 follow-up

Population: The annual hazard rate was assessed separately in each of the 4 lead groups.

Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 2 to year 3

Outcome measures

Measure	Durata Leads n=565 implanted leads Durata leads implanted between 2008-2010	Riata Leads n=305 implanted leads Riata leads implanted between 2002-2009	Riata ST n=229 implanted leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=387 implanted leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads	0 leads w other visual lead anomaly/years Interval 0.0 to 0.0065	0.0066 leads w other visual lead anomaly/years Interval 0.0008 to 0.0235	0 leads w other visual lead anomaly/years Interval 0.0 to 0.016	0 leads w other visual lead anomaly/years Interval 0.0 to 0.0095	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: This outcome is assessed from time of detecting EC till the course of 3 years of follow-up

Population: N at risk from detecting externalized conductors at each follow-up time point

Kaplan-Meier analysis of time from externalized conductors (EC) to electrical dysfunction, by year of initial implant. Count of cumulative lead anomaly events from time of detecting EC

Outcome measures

Measure	Durata Leads n=1 Implant Leads Durata leads implanted between 2008-2010	Riata Leads n=2 Implant Leads Riata leads implanted between 2002-2009	Riata ST n=2 Implant Leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=42 Implant Leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years n=67 Implant Leads lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater n=93 Implant Leads lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years n=23 Implant Leads lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years n=34 Implant Leads lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years n=12 Implant Leads lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years n=12 Implant Leads lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years n=15 Implant Leads lead age: greater than or equal to 6 years
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant year 3 from detecting externalized conductor	NA lead anomaly events no data available	NA lead anomaly events no data available	NA lead anomaly events no data available	2 lead anomaly events	3 lead anomaly events	6 lead anomaly events	1 lead anomaly events	4 lead anomaly events	NA lead anomaly events no data available	0 lead anomaly events	0 lead anomaly events
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant year 0 from detecting externalized conductor	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	1 lead anomaly events	1 lead anomaly events	3 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant year 1 from detecting externalized conductor	0 lead anomaly events	NA lead anomaly events no data available	NA lead anomaly events no data available	2 lead anomaly events	1 lead anomaly events	5 lead anomaly events	0 lead anomaly events	2 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant year 2 from detecting externalized conductor	NA lead anomaly events no data available	NA lead anomaly events no data available	NA lead anomaly events no data available	2 lead anomaly events	2 lead anomaly events	6 lead anomaly events	1 lead anomaly events	2 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events

SECONDARY outcome

Timeframe: This outcome is assessed from time of detecting other visual lead anomaly till the course of 3 years of follow-up

Population: N at risk from detecting other visual lead anomaly

Kaplan-Meier analysis of time from other visual lead anomaly to electrical dysfunction, by year of initial implant. Count of cumulative lead anomaly events from time of detecting other visual lead anomaly

Outcome measures

Measure	Durata Leads n=5 Implant Leads Durata leads implanted between 2008-2010	Riata Leads n=2 Implant Leads Riata leads implanted between 2002-2009	Riata ST n=2 Implant Leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=7 Implant Leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years n=10 Implant Leads lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater n=10 Implant Leads lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years n=6 Implant Leads lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years n=7 Implant Leads lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years n=2 Implant Leads lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years n=3 Implant Leads lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years n=3 Implant Leads lead age: greater than or equal to 6 years
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant 1 years follow up from detecting other visual lead anomaly	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant 2 years follow up from detecting other visual lead anomaly	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant 0 years follow up from detecting other visual lead anomaly	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant 3 years follow up from detecting other visual lead anomaly	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events

SECONDARY outcome

Timeframe: within 30 days associated with study lead related interventions

Population: Subject has at least one market released Riata, Riata ST, QuickSite/QuickFlex, or Durata lead implanted

Number of participants with adverse events within 30 days associated with study lead related interventions for each lead group

Outcome measures

Measure	Durata Leads n=982 Participants Durata leads implanted between 2008-2010	Riata Leads n=670 Participants Riata leads implanted between 2002-2009	Riata ST n=458 Participants Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=737 Participants QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other). Lead dislodgement or migration	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—
Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other). lead insulation damage	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—
Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other). phrenic nerve/diaphragmatic stimulation	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: This outcome is assessed from time of detection of externalized conductor to 3 years follow-up

Population: N at risk from time of externalized conductors at each follow-up period

time from externalized conductors to clinical intervention for all lead subgroups.

Outcome measures

Measure	Durata Leads n=1 Implant Leads Durata leads implanted between 2008-2010	Riata Leads n=2 Implant Leads Riata leads implanted between 2002-2009	Riata ST n=2 Implant Leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=42 Implant Leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years n=67 Implant Leads lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater n=93 Implant Leads lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years n=23 Implant Leads lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years n=34 Implant Leads lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years n=12 Implant Leads lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years n=12 Implant Leads lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years n=15 Implant Leads lead age: greater than or equal to 6 years
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant 3 years from detecting EC	NA lead anomaly events no data available	1 lead anomaly events	1 lead anomaly events	4 lead anomaly events	8 lead anomaly events	18 lead anomaly events	6 lead anomaly events	6 lead anomaly events	1 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant 0 years from detecting EC	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant 1 year from detecting EC	0 lead anomaly events	1 lead anomaly events	1 lead anomaly events	2 lead anomaly events	5 lead anomaly events	11 lead anomaly events	3 lead anomaly events	4 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant 2 years from detecting EC	NA lead anomaly events no data available	1 lead anomaly events	1 lead anomaly events	3 lead anomaly events	7 lead anomaly events	15 lead anomaly events	6 lead anomaly events	4 lead anomaly events	1 lead anomaly events	0 lead anomaly events	0 lead anomaly events

SECONDARY outcome

Timeframe: This outcome is assessed from time of detection of other visual lead anomaly until 3 years of follow-up

Population: N at risk from time of detecting visual lead anomaly at each follow-up period

Kaplan-Meier analysis of time from visual lead anomalies for all lead and lead age subcategories to clinical intervention

Outcome measures

Measure	Durata Leads n=5 Implant Leads Durata leads implanted between 2008-2010	Riata Leads n=2 Implant Leads Riata leads implanted between 2002-2009	Riata ST n=2 Implant Leads Riata ST leads implanted 2006-2009	QuickSite/QuickFlex n=7 Implant Leads QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years n=10 Implant Leads lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater n=10 Implant Leads lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years n=6 Implant Leads lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years n=7 Implant Leads lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years n=2 Implant Leads lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years n=3 Implant Leads lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years n=3 Implant Leads lead age: greater than or equal to 6 years
Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant 3 years from detection other visual lead anomaly	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	2 lead anomaly events	0 lead anomaly events	2 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant 0 years from detection other visual lead anomaly	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant 1 years from detection other visual lead anomaly	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events
Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant 2 years from detection other visual lead anomaly	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events	1 lead anomaly events	0 lead anomaly events	2 lead anomaly events	0 lead anomaly events	2 lead anomaly events	0 lead anomaly events	0 lead anomaly events	0 lead anomaly events

SECONDARY outcome

Timeframe: This outcome is assessed from enrollment till the course of 3 years of follow-up

Population: Patients with Riata or Riata ST leads.

Comparison of patients with EC to those without EC: lead size effect on number of patients with or without EC (7F and 8F are lead sizes, F = French). Riata leads have 8F diameter and Riata ST leads have 7F diameter. The Riata/Riata ST families of leads were used for this comparison only to determine whether the difference in lead size (with the silicon material and other lead design factors controlled for) had an effect on externalization of conductors.

Outcome measures

Measure	Durata Leads n=261 Participants Durata leads implanted between 2008-2010	Riata Leads n=851 Participants Riata leads implanted between 2002-2009	Riata ST Riata ST leads implanted 2006-2009	QuickSite/QuickFlex QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC) 7F lead size (Riata ST)	57 Participants	395 Participants	—	—	—	—	—	—	—	—	—
Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC) 8F lead size (Riata)	204 Participants	456 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: This outcome is assessed from enrollment till the course of 3 years of follow-up

Population: Patients implanted with SJM Riata, Riata ST, Durata, or QuickSite/QuickFlex leads. Leads were combined for this analysis to compare patient groups with and without electrical dysfunction based on age (irrespective of lead implant type)

Comparison of patients with ED to those without ED: subject age effect on ED

Outcome measures

Measure	Durata Leads n=68 Participants Durata leads implanted between 2008-2010	Riata Leads n=2148 Participants Riata leads implanted between 2002-2009	Riata ST Riata ST leads implanted 2006-2009	QuickSite/QuickFlex QuickSite/QuickFlex implanted 2006-2010	Riata Leads Lead Age: 6-less Than 7 Years lead age: 6-less than 7 years	Riata Leads Lead Age: 7 Years or Greater lead age: 7 years or greater	Riata ST Lead Age: Less Than 5.5 Years lead age: less than 5.5 years	Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years lead age: greater than or equal to 5.5 years	QuickSite/QuickFlex Lead Age: Less Than 5 Years lead age: less than 5 years	QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years lead age: 5 to less than 6 years	QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years lead age: greater than or equal to 6 years
Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED).	61.8 years Standard Deviation 13.4	67.2 years Standard Deviation 11.9	—	—	—	—	—	—	—	—	—

Adverse Events

Durata Leads

Serious events: 26 serious events

Other events: 20 other events

Deaths: 130 deaths

Riata Leads

Serious events: 28 serious events

Other events: 14 other events

Deaths: 111 deaths

Riata ST Leads

Serious events: 22 serious events

Other events: 9 other events

Deaths: 64 deaths

QuickSite/QuickFlex Leads

Serious events: 7 serious events

Other events: 11 other events

Deaths: 135 deaths

Serious adverse events

Measure	Durata Leads n=982 participants at risk Subjects implanted with SJM Durata leads	Riata Leads n=670 participants at risk Subjects implanted with Riata leads	Riata ST Leads n=458 participants at risk Subjects implanted with Riata ST leads	QuickSite/QuickFlex Leads n=737 participants at risk Subjects implanted with QuickSite/QuickFlex leads
Product Issues Abnormal high voltage lead impredance	0.31% 3/982 • Number of events 3 • From enrollment to 3 years of follow-up period	0.75% 5/670 • Number of events 5 • From enrollment to 3 years of follow-up period	1.1% 5/458 • Number of events 5 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Abnormal Pacing Impedance	0.81% 8/982 • Number of events 8 • From enrollment to 3 years of follow-up period	0.30% 2/670 • Number of events 2 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Decline in R Wave Sensing	0.10% 1/982 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/670 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Elevated pacing thresholds	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.60% 4/670 • Number of events 4 • From enrollment to 3 years of follow-up period	0.22% 1/458 • Number of events 1 • From enrollment to 3 years of follow-up period	0.27% 2/737 • Number of events 2 • From enrollment to 3 years of follow-up period
Product Issues Externalized Conductor	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.15% 1/670 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Lead dislodgement or migration	0.10% 1/982 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/670 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.27% 2/737 • Number of events 2 • From enrollment to 3 years of follow-up period
Product Issues lead fracture	0.41% 4/982 • Number of events 4 • From enrollment to 3 years of follow-up period	0.30% 2/670 • Number of events 2 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues lead insulation damage	0.20% 2/982 • Number of events 2 • From enrollment to 3 years of follow-up period	0.15% 1/670 • Number of events 1 • From enrollment to 3 years of follow-up period	0.87% 4/458 • Number of events 4 • From enrollment to 3 years of follow-up period	0.14% 1/737 • Number of events 1 • From enrollment to 3 years of follow-up period
Product Issues lead noise	0.41% 4/982 • Number of events 4 • From enrollment to 3 years of follow-up period	1.2% 8/670 • Number of events 8 • From enrollment to 3 years of follow-up period	1.7% 8/458 • Number of events 8 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues oversensing	0.31% 3/982 • Number of events 3 • From enrollment to 3 years of follow-up period	0.45% 3/670 • Number of events 3 • From enrollment to 3 years of follow-up period	0.87% 4/458 • Number of events 4 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues phrenic nerve/diaphragmatic stimulation	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.00% 0/670 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.27% 2/737 • Number of events 2 • From enrollment to 3 years of follow-up period
Product Issues shock due to AF with RVR	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.15% 1/670 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues undersensing	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.15% 1/670 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period

Other adverse events

Measure	Durata Leads n=982 participants at risk Subjects implanted with SJM Durata leads	Riata Leads n=670 participants at risk Subjects implanted with Riata leads	Riata ST Leads n=458 participants at risk Subjects implanted with Riata ST leads	QuickSite/QuickFlex Leads n=737 participants at risk Subjects implanted with QuickSite/QuickFlex leads
Product Issues Abnormal High Voltage Lead Impedance	0.20% 2/982 • Number of events 3 • From enrollment to 3 years of follow-up period	0.30% 2/670 • Number of events 2 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Abnormal Pacing Impedance	0.51% 5/982 • Number of events 6 • From enrollment to 3 years of follow-up period	0.15% 1/670 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.41% 3/737 • Number of events 3 • From enrollment to 3 years of follow-up period
Product Issues Decrease R Wave	0.10% 1/982 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/670 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Elevated pacing thresholds	0.31% 3/982 • Number of events 3 • From enrollment to 3 years of follow-up period	0.30% 2/670 • Number of events 2 • From enrollment to 3 years of follow-up period	0.22% 1/458 • Number of events 1 • From enrollment to 3 years of follow-up period	0.27% 2/737 • Number of events 2 • From enrollment to 3 years of follow-up period
Product Issues Lead Insulation Damage	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.15% 1/670 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Lead Noise	0.41% 4/982 • Number of events 4 • From enrollment to 3 years of follow-up period	0.15% 1/670 • Number of events 1 • From enrollment to 3 years of follow-up period	0.44% 2/458 • Number of events 2 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Loss of Capture	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.00% 0/670 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.14% 1/737 • Number of events 1 • From enrollment to 3 years of follow-up period
Product Issues Loss of Sensing	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.15% 1/670 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Other Visual Lead Anomalies	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.00% 0/670 • From enrollment to 3 years of follow-up period	0.22% 1/458 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Oversensing	0.41% 4/982 • Number of events 4 • From enrollment to 3 years of follow-up period	0.30% 2/670 • Number of events 2 • From enrollment to 3 years of follow-up period	0.66% 3/458 • Number of events 3 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Oversensing Resulting in Therapy	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.00% 0/670 • From enrollment to 3 years of follow-up period	0.22% 1/458 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Pectoral Stimulation	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.00% 0/670 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.14% 1/737 • Number of events 1 • From enrollment to 3 years of follow-up period
Product Issues Phrenic Nerve/Diaphragmatic Stimulation	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.00% 0/670 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.54% 4/737 • Number of events 4 • From enrollment to 3 years of follow-up period
Product Issues Therapy for Non-Ventricular Rhythm	0.10% 1/982 • Number of events 1 • From enrollment to 3 years of follow-up period	0.45% 3/670 • Number of events 3 • From enrollment to 3 years of follow-up period	0.22% 1/458 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period
Product Issues Undersensing	0.00% 0/982 • From enrollment to 3 years of follow-up period	0.15% 1/670 • Number of events 1 • From enrollment to 3 years of follow-up period	0.00% 0/458 • From enrollment to 3 years of follow-up period	0.00% 0/737 • From enrollment to 3 years of follow-up period

Additional Information

Grant Kim, Program Director - Traditional Cardiac Rhythm Management

Abbott

Phone: 818-493-3147

Email: grant.kim1@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and embargo communications regarding trial results for 12 months from study completion date to allow time for multi-center study publication. After this period, the PI shall submit to sponsor for review a copy of any proposed manuscript at least 30 days prior to the estimated date of submission for publication. Sponsor may require delay of publication not to exceed 60 days for the purpose of filing patent applications.
• Publication restrictions are in place

Restriction type: OTHER