Trial Outcomes & Findings for Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918) (NCT NCT03257436)

NCT ID: NCT03257436

Last Updated: 2022-01-03

Results Overview

Proportion of subjects free from LVMSP feature related complications at 12 months

Recruitment status

COMPLETED

Study phase

Target enrollment

586 participants

Primary outcome timeframe

Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.

Results posted on

2022-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. CRT-D: Left Ventricular MultiSite Pacing
Overall Study STARTED	584
Overall Study COMPLETED	489
Overall Study NOT COMPLETED	95

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. CRT-D: Left Ventricular MultiSite Pacing
Overall Study Withdrawal by Subject	76
Overall Study Death	19

Baseline Characteristics

Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=583 Participants General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. CRT-D: Left Ventricular MultiSite Pacing
Age, Continuous	66.7 Years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	211 Participants n=5 Participants
Sex: Female, Male Male	372 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	95 Participants n=5 Participants
Race (NIH/OMB) White	460 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants
Region of Enrollment United States	583 participants n=5 Participants

PRIMARY outcome

Timeframe: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.

Population: Subjects who are non-responders at the 6 month follow up and who have LVMSP enabled for for any duration between the 6th and 12 month visit

Proportion of subjects free from LVMSP feature related complications at 12 months

Outcome measures

Outcome measures
Measure	Single Arm n=102 Participants General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. CRT-D: Left Ventricular MultiSite Pacing
LV MSP Feature Related Complication-Free Rate	99 percentage of participants Interval 94.1 to As prespecified in the study protocol the lower one-sided 95% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).

PRIMARY outcome

Timeframe: 12 Month Follow Up

Population: Non-responders at 6 Months who had LV MSP enabled and had complete clinical composite score data, LV MSP on and achieved \>93% LVa and LVb pacing

Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.

Outcome measures

Outcome measures
Measure	Single Arm n=78 Participants General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. CRT-D: Left Ventricular MultiSite Pacing
Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months	51.3 percentage of participants Interval 41.4 to The 95% one-sided lower pointwise confidence limit of the response rate was calculated using the one-sided exact methodology for a single binomial proportion and compared to the performance goal of 5%.

Adverse Events

Single Arm

Serious events: 131 serious events

Other events: 72 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=584 participants at risk General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
Blood and lymphatic system disorders Hematological	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Atrial Fibrillation (AF)	0.68% 4/584 • Number of events 5 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)	0.68% 4/584 • Number of events 4 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Cardiac arrest	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Cardiogenic shock	0.51% 3/584 • Number of events 4 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Chest pain - Heart failure	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Dyspnea - Heart failure	2.6% 15/584 • Number of events 22 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Gastrointestinal - Heart failure	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Eye disorders Heart failure symptoms - Unspecified	1.4% 8/584 • Number of events 10 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Incessant VT/VT Storm	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Mitral regurgitation	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Multi-system failure - Heart failure	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Multiple Ventricular Arrhythmias	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Multiple heart failure symptoms	3.8% 22/584 • Number of events 28 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Other - Heart failure patient condition- Cardiovascular	0.68% 4/584 • Number of events 4 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Other - Patient condition - Cardiovascular	0.17% 1/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Palpitations	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Pericardial effusion - Unrelated (non study) procedure or device	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Pulmonary edema - Heart failure	0.51% 3/584 • Number of events 3 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Renal insufficiency/failure - Heart failure	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Valvular damage/Valvular insufficiency	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Ventricular Fibrillation (VF)	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Ventricular Tachycardia (VT)/Monomorphic VT	1.4% 8/584 • Number of events 8 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Weight gain - Heart failure	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Atrial (Type 1) Flutter	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Gastrointestinal disorders Gastrointestinal	2.1% 12/584 • Number of events 13 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Endocrine disorders Endocrine	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Chest Pain - Other	0.86% 5/584 • Number of events 7 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Death	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Fatigue and Weakness	0.51% 3/584 • Number of events 3 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders HEENT	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Multi-System Failure	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Other-Patient Condition-Non-Cardiovascular	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Physical Trauma	0.51% 3/584 • Number of events 3 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Syncope	0.68% 4/584 • Number of events 4 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Infections and infestations Fever and/or Virus	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Infections and infestations Infection (>30 days post-implant) - PG System - Subject related	0.68% 4/584 • Number of events 4 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Infections and infestations Localized Infection	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Infections and infestations Systemic Infection	0.68% 4/584 • Number of events 4 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Injury, poisoning and procedural complications Hematoma - Pocket (<=30 days post-implant)	0.51% 3/584 • Number of events 3 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Injury, poisoning and procedural complications Post-surgical infection (<=30 days post-implant)	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Injury, poisoning and procedural complications Seroma - Pocket (<=30 days post-implant)	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Musculoskeletal and connective tissue disorders Musculoskeletal	0.51% 3/584 • Number of events 3 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.86% 5/584 • Number of events 5 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Nervous system disorders Neurological	0.68% 4/584 • Number of events 5 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Dislodgement - LV	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Dislodgement - RA	0.51% 3/584 • Number of events 4 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Dislodgement - RV	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Erosion - PG System - Subject related	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Inappropriate Tachy Therapy - SVT - PG System Therapy	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Inappropriate tachy therapy - SVT - Defibrillation lead	0.51% 3/584 • Number of events 4 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Renal and urinary disorders Genitourinary	1.2% 7/584 • Number of events 8 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Renal and urinary disorders Renal	2.4% 14/584 • Number of events 16 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.68% 4/584 • Number of events 4 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Respiratory, thoracic and mediastinal disorders Pulmonary	1.7% 10/584 • Number of events 11 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Skin and subcutaneous tissue disorders Integumentary	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Cerebrovascular Accident (CVA) - unspecifed	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Coronary Artery Disease	0.51% 3/584 • Number of events 3 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Hematoma - Unrelated (non study) procedure or device	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Hypotension/Orthostatic Hypotension	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Myocardial Infacrtion	0.86% 5/584 • Number of events 5 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Pseudoaneurysm with hematoma	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Pulmonary Embolism	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.

Other adverse events

Other adverse events
Measure	Single Arm n=584 participants at risk General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
Cardiac disorders Premature Atrial Contraction (PAC)	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Premature Ventricular Contractions (PVC)	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Sinus tachycardia	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Ventricular Fibrillation (VF)	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Ventricular Tachycardia (VT)/Monomorphic VT	0.34% 2/584 • Number of events 3 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Cardiac disorders Weight gain - Heart failure	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Gastrointestinal disorders Gastrointestinal	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Abnormal laboratory values	0.17% 1/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Adverse reaction - Medication	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Chest pain - Other	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Dizziness	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Head, eyes, ears, nose, throat (HEENT)	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Multiple symptoms	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Other - Patient condition- Non-cardiovascular	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
General disorders Physical trauma	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Infections and infestations Localized Infection	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Injury, poisoning and procedural complications Hematoma - Pocket (<=30 days post-implant)	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Injury, poisoning and procedural complications Post-surgical infection (<=30 days post-implant)	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Injury, poisoning and procedural complications Post-surgical wound discomfort/bruising/swelling	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Injury, poisoning and procedural complications Thromboembolic events	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Musculoskeletal and connective tissue disorders Musculoskeletal	0.51% 3/584 • Number of events 3 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Dislodgment - RA	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Elevated threshold - LV Lead	0.51% 3/584 • Number of events 3 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Extracardiac stimulation - LV Lead	3.6% 21/584 • Number of events 22 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Extracardiac stimulation - RV Lead	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Inappropriate tachy therapy - NSR -Defibrillation lead	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Inappropriate tachy therapy - SVT - Defibrillation lead	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Product Issues Pacemaker Mediated Tachycardia - PG System Therapy	1.4% 8/584 • Number of events 8 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Renal and urinary disorders Genitourinary	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Respiratory, thoracic and mediastinal disorders Pulmonary	0.34% 2/584 • Number of events 2 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Skin and subcutaneous tissue disorders Integumentary	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Arterial/venous thrombolytic event	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Chest pain - Ischemic	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Hypotension/Orthostatic Hypotension	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
Vascular disorders Peripheral vascular disease	0.17% 1/584 • Number of events 1 • Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up. Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.

Additional Information

Sharda Mehta

BostonScientific

Phone: 6785967330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place