Strategic MAnagement to Optimize Response To Cardiac Resy... | NCT03075215

NCT03075215

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)	Device	The optimization during the standard of care visits in the first 12 months following implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CRT Response Rate	The traditional outcome of interest when using the Clinical Composite Score (CCS) is the proportion of patients who improved. Improvement was defined as remaining alive and free of heart failure hospitalization while also demonstrating improvement in NYHA Class, patient Global Assessment, or both. Patients were considered worsened if they died, experienced a heart failure hospitalization, or had worsened NYHA Class or patient Global Assessment. Patients who neither improved nor worsened were classified as "no change."	12 months
Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications	Complication Free rate. PG-related Complication is defined as those detectable adverse events that resulted in: Death Serious injury Correction of PG failure requiring invasive intervention Permanent loss of PG device function. Permanent loss of device function is defined as any Pulse Generator (PG) that reverts to Safety Core or any PG rendered unable to deliver pacing or shocks Complications that are determined to be associated with the PG will be considered PGrelated complications (PG) and count against the PMCF endpoint. Complications related to the LV, RV, RA leads will not be counted against the PMCF endpoint.	36 months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jose-Ignacio Garcia-Bolao, PhD, FESC	Clinica Universidad de Navarra	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Providence Alaska Medical Center		Anchorage	Alaska	99508	United States
CardioVascular Associates of Mesa

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.	Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 6, 2017

Arm/Group Information

ID	Title	Description
BG000	Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.	Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00067.5± 10.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000462
Male	BG0001543

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG0001230

Black

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

CRT Response Rate

The traditional outcome of interest when using the Clinical Composite Score (CCS) is the proportion of patients who improved. Improvement was defined as remaining alive and free of heart failure hospitalization while also demonstrating improvement in NYHA Class, patient Global Assessment, or both. Patients were considered worsened if they died, experienced a heart failure hospitalization, or had worsened NYHA Class or patient Global Assessment. Patients who neither improved nor worsened were classified as "no change."

Subjects must have a complete composite score at 12 months of follow up

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.	Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up.

Units	Counts
Participants	OG0001558

Title

Denominators

Categories

Title	Measurements
Improved	OG000918
No Change	OG000312
Worsened	OG000

Primary

Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications

Complication Free rate. PG-related Complication is defined as those detectable adverse events that resulted in:

Death
Serious injury
Correction of PG failure requiring invasive intervention
Permanent loss of PG device function. Permanent loss of device function is defined as any Pulse Generator (PG) that reverts to Safety Core or any PG rendered unable to deliver pacing or shocks Complications that are determined to be associated with the PG will be considered PGrelated complications (PG) and count against the PMCF endpoint. Complications related to the LV, RV, RA leads will not be counted against the PMCF endpoint.

A total of 103 subjects were classified as NG4 PMCF subjects at time of enrollment, among them 4 subjects data sets were not cleaned and unable to get corrected upon the end of the study. The final analyzed count is 99 subjects.

Posted

Number

% of participants

36 months

ID	Title	Description
OG000	Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.	Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.	Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up. Any reportable adverse events (including deaths) from these 103 subjects, are represented in the mortality and adverse event sections of the results.	152	2,015	575	2,015	132	2,015

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Hematological	Blood and lymphatic system disorders	Non-systematic Assessment	EG00011 events9 affected2,015 at risk
Aortic Regurgitation	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected2,015 at risk
Aortic Stenosis	Cardiac disorders	Systematic Assessment	EG0004 events4 affected2,015 at risk
Arrhythmia-Other	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Atrial Fibrillation (AF)	Cardiac disorders	Systematic Assessment	EG00043 events43 affected2,015 at risk
Atrial Flutter	Cardiac disorders	Systematic Assessment	EG00010 events10 affected2,015 at risk
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected2,015 at risk
Cardiac Arrest	Cardiac disorders	Systematic Assessment	EG00013 events13 affected2,015 at risk
Cardiac Medication Complication - Heart Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Cardiogenic Shock	Cardiac disorders	Systematic Assessment	EG00010 events10 affected2,015 at risk
Chest Pain - Heart Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Dyspnea - Heart Failure	Cardiac disorders	Systematic Assessment	EG00040 events36 affected2,015 at risk
Gastrointestinal - Heart Failure	Cardiac disorders	Systematic Assessment	EG0002 events2 affected2,015 at risk
Heart Failure Patient Condition - Cardiovascular - OTHER	Cardiac disorders	Systematic Assessment	EG0009 events9 affected2,015 at risk
Heart Failure Symptoms - Unspecified	Cardiac disorders	Systematic Assessment	EG00074 events63 affected2,015 at risk
Hypotension - Heart Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Incessant VT/ VT Storm	Cardiac disorders	Systematic Assessment	EG0004 events4 affected2,015 at risk
Intracardiac thrombus	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Mitral Regurgitation	Cardiac disorders	Systematic Assessment	EG0003 events3 affected2,015 at risk
Multi-system Failure - Heart Failure	Cardiac disorders	Systematic Assessment	EG0006 events6 affected2,015 at risk
Multiple Heart Failure Symptoms	Cardiac disorders	Systematic Assessment	EG000108 events84 affected2,015 at risk
Nonsustained ventricular tachycardia (NSVT)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected2,015 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0006 events5 affected2,015 at risk
Patient Condition - Cardiovascular - OTHER	Cardiac disorders	Systematic Assessment	EG0006 events5 affected2,015 at risk
Pericardial effusion - unrelated procedure/device	Cardiac disorders	Systematic Assessment	EG0004 events4 affected2,015 at risk
Peripheral edema - Heart Failure	Cardiac disorders	Systematic Assessment	EG0006 events6 affected2,015 at risk
Pleural Effusion - Heart Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Premature Ventricular Contractions (PVC)	Cardiac disorders	Systematic Assessment	EG0003 events3 affected2,015 at risk
Pulmonary Edema - Heart Failure	Cardiac disorders	Systematic Assessment	EG0006 events6 affected2,015 at risk
Pulseless Electrical Activity (PEA)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Renal Failure/Insufficiency - Heart Failure	Cardiac disorders	Systematic Assessment	EG0004 events4 affected2,015 at risk
Syncope - Heart Failure	Cardiac disorders	Systematic Assessment	EG0003 events3 affected2,015 at risk
Valvular Damage/Valvular insufficiency	Cardiac disorders	Systematic Assessment	EG0002 events2 affected2,015 at risk
Ventricular Fibrillation (VF)	Cardiac disorders	Systematic Assessment	EG00010 events9 affected2,015 at risk
Ventricular Tachycardia (VT)/Monomorphic VT	Cardiac disorders	Systematic Assessment	EG00040 events27 affected2,015 at risk
Endocrine	Endocrine disorders	Systematic Assessment	EG0008 events8 affected2,015 at risk
Gastrointestinal	Gastrointestinal disorders	Systematic Assessment	EG00044 events30 affected2,015 at risk
Adverse Reaction - Medication	General disorders	Systematic Assessment	EG0004 events4 affected2,015 at risk
Chest Pain - Other	General disorders	Systematic Assessment	EG0007 events7 affected2,015 at risk
Death	General disorders	Systematic Assessment	EG00034 events34 affected2,015 at risk
Dizziness	General disorders	Non-systematic Assessment	EG0003 events3 affected2,015 at risk
Fatigue/Weakness	General disorders	Systematic Assessment	EG0002 events2 affected2,015 at risk
Head, eyes, ears, nose, throat (HEENT)	General disorders	Systematic Assessment	EG0004 events3 affected2,015 at risk
Multi-System Failure	General disorders	Systematic Assessment	EG0005 events5 affected2,015 at risk
Multiple Symptoms	General disorders	Systematic Assessment	EG0004 events4 affected2,015 at risk
Patient Condition - Non-Cardiovascular - OTHER	General disorders	Systematic Assessment	EG0003 events3 affected2,015 at risk
Physical Trauma	General disorders	Systematic Assessment	EG00019 events17 affected2,015 at risk
Syncope	General disorders	Systematic Assessment	EG0006 events6 affected2,015 at risk
Immune	Immune system disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Fever and/or Virus	Infections and infestations	Systematic Assessment	EG0001 events1 affected2,015 at risk
Infection (> 30 days post implant)	Infections and infestations	Systematic Assessment	EG00010 events10 affected2,015 at risk
Localized Infection	Infections and infestations	Systematic Assessment	EG0008 events7 affected2,015 at risk
System Infection	Infections and infestations	Systematic Assessment	EG00022 events20 affected2,015 at risk
Hematoma - pocket (≤ 30 days post-implant)	Injury, poisoning and procedural complications	Systematic Assessment	EG0005 events4 affected2,015 at risk
Pneumothorax	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected2,015 at risk
Post Surgical wound discomfort/bruising/swelling	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected2,015 at risk
Post -Surgical infection (≤ 30 days post implant)	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected2,015 at risk
Post-surgical pocket hemorrhage/bleeding/drainage	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected2,015 at risk
Procedure - PG System - Other	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected2,015 at risk
Unrelated procedure/device - OTHER	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected2,015 at risk
Venous occlusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected2,015 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00012 events11 affected2,015 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG00022 events15 affected2,015 at risk
Neurological	Nervous system disorders	Systematic Assessment	EG00015 events15 affected2,015 at risk
Conductor Coil Fracture - RA	Product Issues	Systematic Assessment	EG0002 events2 affected2,015 at risk
Conductor Coil Fracture - RV	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Dislodgement - Elevated Threshold - RA	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Dislodgement - Elevated threshold - LV	Product Issues	Systematic Assessment	EG0004 events3 affected2,015 at risk
Dislodgement - Elevated threshold - RV	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Dislodgement - Extracardiac stimulation - LV	Product Issues	Systematic Assessment	EG0003 events3 affected2,015 at risk
Dislodgement - Extracardiac stimulation - RV	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Dislodgement - Multiple signs - LV	Product Issues	Systematic Assessment	EG0003 events3 affected2,015 at risk
Dislodgement - Multiple signs - RV	Product Issues	Systematic Assessment	EG0003 events2 affected2,015 at risk
Dislodgement - Multiple signs- RA	Product Issues	Systematic Assessment	EG0002 events2 affected2,015 at risk
Dislodgement - No reported signs - LV	Product Issues	Systematic Assessment	EG0006 events6 affected2,015 at risk
Dislodgement - No reported signs - RA	Product Issues	Systematic Assessment	EG0004 events4 affected2,015 at risk
Dislodgement - No reported signs - RV	Product Issues	Systematic Assessment	EG0004 events4 affected2,015 at risk
Dislodgement - Unable to Capture - LV	Product Issues	Systematic Assessment	EG0003 events3 affected2,015 at risk
Dislodgement - Unable to capture - RV	Product Issues	Systematic Assessment	EG0005 events5 affected2,015 at risk
Electrode Damaged - RA	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Elevated Threshold - LV	Product Issues	Non-systematic Assessment	EG0001 events1 affected2,015 at risk
Elevated Threshold - RA	Product Issues	Systematic Assessment	EG0002 events2 affected2,015 at risk
Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV	Product Issues	Systematic Assessment	EG0005 events5 affected2,015 at risk
Extracardiac Stimulation - LV	Product Issues	Systematic Assessment	EG0007 events6 affected2,015 at risk
Helix damaged - RA	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
High Out of Range Impedance - LV	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Impedance Out of Range	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Inappropriate Tachy Therapy - SVT	Product Issues	Systematic Assessment	EG0002 events2 affected2,015 at risk
Inappropriate tachy therapy - SVT	Product Issues	Systematic Assessment	EG0003 events3 affected2,015 at risk
Inappropriate tachy therapy - Other	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Other Lead Related	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
PG System diagnosis - OTHER	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
PG System - Patient Related - OTHER	Product Issues	Systematic Assessment	EG0003 events3 affected2,015 at risk
Unable to Capture - LV	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Unable to Capture - RV	Product Issues	Systematic Assessment	EG0002 events2 affected2,015 at risk
Unable to Capture - RA	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Psychological	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected2,015 at risk
Genitourinary	Renal and urinary disorders	Systematic Assessment	EG00012 events10 affected2,015 at risk
Renal	Renal and urinary disorders	Systematic Assessment	EG00036 events30 affected2,015 at risk
Adverse Reaction - Respiratory	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
COPD Exacerbation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 events4 affected2,015 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events4 affected2,015 at risk
Pleural Effusion - unrelated procedure/device	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected2,015 at risk
Pneumothorax - unrelated procedure/device	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events1 affected2,015 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00047 events35 affected2,015 at risk
Integumentary	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0004 events4 affected2,015 at risk
Skin burns	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Cerebrovascular Accident (CVA)	Vascular disorders	Systematic Assessment	EG0003 events3 affected2,015 at risk
Cerebrovascular accident (CVA) - ischemic	Vascular disorders	Systematic Assessment	EG0006 events6 affected2,015 at risk
Chest Pain - Ischemic	Vascular disorders	Systematic Assessment	EG0006 events6 affected2,015 at risk
Coronary Artery Disease	Vascular disorders	Systematic Assessment	EG00017 events16 affected2,015 at risk
Deep Vein Thrombosis (DVT)	Vascular disorders	Systematic Assessment	EG0003 events3 affected2,015 at risk
Hypotension/Orthostatic Hypotension	Vascular disorders	Systematic Assessment	EG0004 events4 affected2,015 at risk
Myocardial Infarction	Vascular disorders	Systematic Assessment	EG00010 events9 affected2,015 at risk
Peripheral Vascular Disease	Vascular disorders	Systematic Assessment	EG00012 events11 affected2,015 at risk
Pulmonary Embolism (PE)	Vascular disorders	Systematic Assessment	EG0005 events5 affected2,015 at risk
Transient Ischemic Attack (TIA)	Vascular disorders	Systematic Assessment	EG0004 events3 affected2,015 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Atrial (Type I) Flutter	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected2,015 at risk
Atrial Fibrillation (AF)	Cardiac disorders	Systematic Assessment	EG00018 events16 affected2,015 at risk
Atrial Flutter	Cardiac disorders	Systematic Assessment	EG0003 events3 affected2,015 at risk
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)	Cardiac disorders	Systematic Assessment	EG0003 events3 affected2,015 at risk
Dyspnea - Heart Failure	Cardiac disorders	Systematic Assessment	EG00016 events13 affected2,015 at risk
Heart Failure Patient Condition - Cardiovascular - OTHER	Cardiac disorders	Systematic Assessment	EG0003 events2 affected2,015 at risk
Heart Failure Symptoms - Unspecified	Cardiac disorders	Systematic Assessment	EG0009 events6 affected2,015 at risk
Intracardiac thrombus	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Mitral Regurgitation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Multiple Heart Failure Symptoms	Cardiac disorders	Systematic Assessment	EG0008 events7 affected2,015 at risk
Patient Condition - Cardiovascular - OTHER	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Pericardial Effusion - Heart Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Peripheral edema - Heart Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Premature Ventricular Contractions (PVC)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected2,015 at risk
Torsades de Pointes	Cardiac disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Ventricular Fibrillation (VF)	Cardiac disorders	Systematic Assessment	EG0007 events5 affected2,015 at risk
Ventricular Tachycardia (VT)/Monomorphic VT	Cardiac disorders	Systematic Assessment	EG00017 events17 affected2,015 at risk
Chest Pain - Other	General disorders	Systematic Assessment	EG0003 events3 affected2,015 at risk
Head, eyes, ears, nose, throat (HEENT)	General disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Syncope	General disorders	Systematic Assessment	EG0002 events2 affected2,015 at risk
Vasovagal Reaction	General disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Infection (> 30 days post implant)	Infections and infestations	Systematic Assessment	EG0001 events1 affected2,015 at risk
System Infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected2,015 at risk
Post Surgical wound discomfort/bruising/swelling	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected2,015 at risk
Post-surgical pocket hemorrhage/bleeding/drainage	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected2,015 at risk
Thromboembolic events	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected2,015 at risk
Venous occlusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected2,015 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected2,015 at risk
Conductor Coil Fracture - RA	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Dislodgement - Elevated threshold - RV	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Dislodgement - Multiple signs - LV	Pregnancy, puerperium and perinatal conditions	Systematic Assessment	EG0002 events2 affected2,015 at risk
Dislodgement - No reported signs - LV	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Elevated Threshold - LV	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Elevated Threshold - RA	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV	Product Issues	Systematic Assessment	EG0002 events2 affected2,015 at risk
Extracardiac Stimulation - LV	Product Issues	Systematic Assessment	EG00021 events20 affected2,015 at risk
Inappropriate Tachy Therapy - SVT	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Inappropriate tachy therapy - SVT	Product Issues	Systematic Assessment	EG0004 events4 affected2,015 at risk
Inappropriate tachy therapy - NSR	Product Issues	Systematic Assessment	EG0002 events2 affected2,015 at risk
Inappropriate tachy therapy - Other	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Other - PG System	Product Issues	Non-systematic Assessment	EG0001 events1 affected2,015 at risk
Oversensing - RA	Product Issues	Systematic Assessment	EG0001 events1 affected2,015 at risk
Pacemaker Mediated Tachycardia (PMT)	Product Issues	Systematic Assessment	EG0005 events5 affected2,015 at risk
Renal	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected2,015 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events1 affected2,015 at risk
Hypotension/Orthostatic Hypotension	Vascular disorders	Systematic Assessment	EG0002 events2 affected2,015 at risk

Limitations include a lack of a control group, but a non-randomized observational study with 2005 subjects is appropriate to meet the study's objectives to obtain "real world" therapy outcome. Due to COVID-19, there was an increase in missed visits/withdrawals, the impact to the data was minimal, 75.8% of 12-month visits were before March 2020 and there was sufficient data to power the 36-month analysis.

Certain Agreements

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases