Trial Outcomes & Findings for Safety and Performance Study of the Siello S Pacing Lead (NCT NCT01791127)
NCT ID: NCT01791127
Last Updated: 2020-06-01
Results Overview
The overall percentage subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).
Recruitment status
TERMINATED
Target enrollment
1758 participants
Primary outcome timeframe
12 month
Results posted on
2020-06-01
Participant Flow
Participant milestones
| Measure |
BIOTRONIK Siello S Lead
Patients with a BIOTRONIK pacemaker system including one or two Siello S leads.
|
|---|---|
|
Overall Study
STARTED
|
1758
|
|
Overall Study
COMPLETED
|
286
|
|
Overall Study
NOT COMPLETED
|
1472
|
Reasons for withdrawal
| Measure |
BIOTRONIK Siello S Lead
Patients with a BIOTRONIK pacemaker system including one or two Siello S leads.
|
|---|---|
|
Overall Study
Death
|
356
|
|
Overall Study
Patient has withdrawn from study
|
293
|
|
Overall Study
Lost to Follow-up
|
42
|
|
Overall Study
All Siello leads are explanted
|
31
|
|
Overall Study
Completion of 30 day safety registry
|
1
|
|
Overall Study
Study terminated for EP Passion
|
749
|
Baseline Characteristics
Baseline characteristics are provided when available, subjects without available baseline characteristics are not included in the number of participants analyzed in this section.
Baseline characteristics by cohort
| Measure |
BIOTRONIK Siello S Lead
n=1758 Participants
Patients with a BIOTRONIK pacemaker system including one or two Siello S leads.
|
|---|---|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 10.9 • n=1758 Participants
|
|
Sex: Female, Male
Female
|
821 Participants
n=1758 Participants
|
|
Sex: Female, Male
Male
|
937 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
White
|
1380 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
112 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
47 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
193 Participants
n=1758 Participants
|
|
Region of Enrollment
United States
|
1758 participants
n=1758 Participants
|
|
Weight
|
187.8 pounds
STANDARD_DEVIATION 51.6 • n=1752 Participants • Baseline characteristics are provided when available, subjects without available baseline characteristics are not included in the number of participants analyzed in this section.
|
|
Height
|
66.9 inches
STANDARD_DEVIATION 4.3 • n=1749 Participants • Baseline characteristics are provided when available, subjects without available baseline characteristics are not included in the number of participants analyzed in this section.
|
PRIMARY outcome
Timeframe: 12 monthPopulation: The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of an atrial Siello lead on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.
The overall percentage subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=450 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Atrial Siello S Lead Safety at 12 Months
|
100 percentage of participants
Interval 99.2 to 100.0
|
—
|
PRIMARY outcome
Timeframe: 12-monthPopulation: The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of a ventricular Siello lead on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.
The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=525 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Ventricular Siello S Lead Safety at 12 Months
|
99.62 percentage of participants
Interval 98.6 to 100.0
|
—
|
PRIMARY outcome
Timeframe: 12-monthsPopulation: The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of one or more Siello leads on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.
Success rate of the implanted system to sense and deliver pacing at 12-months post implant.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=538 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Siello S Lead Effectiveness at 12 Months
|
100 percentage of participants
Interval 99.3 to 100.0
|
—
|
PRIMARY outcome
Timeframe: 5-YearsPopulation: The Post-Market cohort included all patient who were enrolled in the study and had a Siello lead implanted in the right ventricular position.
The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=1728 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Ventricular Siello S Lead Safety at 5 Years
|
99.71 percentage of participants
Interval 99.33 to 99.91
|
—
|
PRIMARY outcome
Timeframe: 5-yearsPopulation: The Post-Market cohort included all patient who were enrolled in the study and had a Siello lead implanted in the right ventricular position.
Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=1728 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Lead impedance out of range, High
|
0.17 percentage of participants
Interval 0.04 to 0.51
|
—
|
|
Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Lead conductor fracture
|
0.12 percentage of participants
Interval 0.01 to 0.42
|
—
|
SECONDARY outcome
Timeframe: 5-yearsPopulation: The Post-Market cohort included all patient who were enrolled in the study and had a Siello lead implanted in the right atrial position.
The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=1493 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Atrial Siello S Lead Safety at 5 Years
|
99.87 percentage of participants
Interval 99.52 to 99.98
|
—
|
SECONDARY outcome
Timeframe: 5-yearsPopulation: On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.
Evaluation of the individual adverse events contributing to the outcome measure 'Atrial Siello S Lead Safety at 5 Years'.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=1493 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Intermittent capture
|
0.07 percentage of participants
Interval 0.01 to 0.37
|
—
|
|
Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Suspected lead failure
|
0.07 percentage of participants
Interval 0.01 to 0.37
|
—
|
SECONDARY outcome
Timeframe: 12-monthsPopulation: All originally implanted ventricular or atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.
Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=505 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
n=389 Participants
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Pacing Threshold Measurements for Siello S Leads at 12 Months
|
0.86 volts
Standard Deviation 0.29
|
0.85 volts
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 12-monthsPopulation: All originally implanted ventricular or atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.
Sensing measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=446 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
n=429 Participants
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Sensing Measurements for Siello S Leads at 12 Months
|
12.68 mV
Standard Deviation 5.02
|
3.66 mV
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: 12-monthsPopulation: All originally implanted ventricular or atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.
Impedance measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=515 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
n=441 Participants
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Impedance Measurements for Siello S Leads at 12 Months
|
595.7 Ohms
Standard Deviation 89.1
|
524.0 Ohms
Standard Deviation 66.7
|
SECONDARY outcome
Timeframe: 5-yearsPopulation: The Post-Market cohort included all patient who were enrolled in the study and had one or two Siello leads implanted.
The overall percentage of subjects with reportable adverse events that were excluded from primary and secondary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR). Adverse events were considered reportable if the event was related to the implant procedure, implanted pulse generator, or implanted leads.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=1758 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Percentage of Participants With Other Adverse Events
|
84.02 percentage of participants
Interval 82.22 to 85.7
|
—
|
SECONDARY outcome
Timeframe: 5-yearsPopulation: The Post-Market cohort included all patient who were enrolled in the study and had one or two Siello leads implanted.
Success rate of the implanted system to deliver long-term pacing at 5-years post-implant.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=1758 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Siello S Lead Effectiveness at 5 Years
|
99.94 percentage of participants
Interval 99.68 to 99.99
|
—
|
SECONDARY outcome
Timeframe: 5-yearsPopulation: All originally implanted ventricular or atrial Siello leads with implant and follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.
Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle through 5 years of follow-up.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=1727 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
n=1493 Participants
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Pacing Threshold Measurements for Siello S Leads Through 5 Years
|
0.84 volts
Standard Deviation 0.34
|
0.83 volts
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: 5-yearsPopulation: All originally implanted ventricular or atrial Siello leads with implant and follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.
Sensing measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=1727 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
n=1493 Participants
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Sensing Measurements for Siello S Leads Through 5 Years
|
12.17 mV
Standard Deviation 4.60
|
3.53 mV
Standard Deviation 1.95
|
SECONDARY outcome
Timeframe: 5-yearsPopulation: All originally implanted ventricular or atrial Siello leads with implant and follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.
Impedance measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.
Outcome measures
| Measure |
BIOTRONIK Siello S Atrial Lead
n=1727 Participants
Patients in the pre-market cohort with a BIOTRONIK pacemaker system including a Siello S atrial lead.
|
Siello S Atrial Leads
n=1493 Participants
All originally implanted atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis. For data poolability, thresholds performed with a pulse-width of 0.4 or 0.5 ms were requested. Only data collected at 0.4 or 0.5 ms pulse-width was analyzed and reported.
|
|---|---|---|
|
Impedance Measurements for Siello S Leads Through 5 Years
|
597.6 Ohms
Standard Deviation 100.0
|
514.4 Ohms
Standard Deviation 72.6
|
Adverse Events
BIOTRONIK Siello S Lead
Serious events: 145 serious events
Other events: 154 other events
Deaths: 356 deaths
Serious adverse events
| Measure |
BIOTRONIK Siello S Lead
n=1758 participants at risk
Patients with a BIOTRONIK pacemaker system including one or two Siello S leads.
|
|---|---|
|
Cardiac disorders
Accumulation of serous fluid in pocket
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 RA lead
|
0.23%
4/1758 • Number of events 4 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.17%
3/1758 • Number of events 4 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 Siello lead
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 RA lead
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Lead related thrombosis
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Pulse generator failure
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Pulse generator migration
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 (non-Siello) lead dislodgement
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 high pacing threshold
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
2.2%
39/1758 • Number of events 41 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 suspected lead failure
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 undersensing or loss of sensing
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 conductor fracture
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.17%
3/1758 • Number of events 3 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 intermittent capture, no lead capture
|
0.17%
3/1758 • Number of events 3 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 lead insulation failure
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 (non-Siello) lead dislodgement
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.28%
5/1758 • Number of events 5 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
1.3%
22/1758 • Number of events 23 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Software malfunction
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.28%
5/1758 • Number of events 5 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.80%
14/1758 • Number of events 16 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Prosthetic aortic valve endocarditis
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Damage to lead during procedure
|
0.34%
6/1758 • Number of events 6 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.51%
9/1758 • Number of events 10 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Lead dislodgement during a procedure
|
0.23%
4/1758 • Number of events 5 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Lead reversed in header
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.34%
6/1758 • Number of events 6 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.46%
8/1758 • Number of events 8 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Pocket pain
|
0.34%
6/1758 • Number of events 8 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Possible transient ischemic attack
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Pulmonary embolism
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.17%
3/1758 • Number of events 3 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 |
BIOTRONIK Siello S Lead
n=1758 participants at risk
Patients with a BIOTRONIK pacemaker system including one or two Siello S leads.
|
|---|---|
|
Cardiac disorders
Atrial oversensing
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 Siello lead
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Failure of fixation helix to retract
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 intermittent capture, no lead capture
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 diaphragmatic stimulation
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.85%
15/1758 • Number of events 16 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.63%
11/1758 • Number of events 12 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.17%
3/1758 • Number of events 3 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 (non-Siello) undersensing or loss of sensing
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 intermittent capture, no lead capture
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 (non-Siello) high pacing threshold
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 high pacing threshold
|
0.68%
12/1758 • Number of events 12 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.17%
3/1758 • Number of events 3 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 undersensing or loss of sensing
|
0.63%
11/1758 • Number of events 11 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.17%
3/1758 • Number of events 3 • Up to 5 years
According to the study protocol, sites were required to report all patient 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 (non-Siello) high pacing threshold
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.80%
14/1758 • Number of events 14 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.28%
5/1758 • Number of events 6 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Transient inhibition secondary to EMI
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
1.1%
19/1758 • Number of events 19 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Allergic reaction at pocket site
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Damage to lead during procedure
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
1.7%
30/1758 • Number of events 30 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Inability to place LV lead
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Inability to place RA lead
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Inability to place RV lead
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.11%
2/1758 • Number of events 2 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
Pocket pain
|
0.40%
7/1758 • Number of events 7 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
RA lead dislodgement during a procedure
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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
|
0.06%
1/1758 • Number of events 1 • Up to 5 years
According to the study protocol, sites were required to report all patient 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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place