Improve Sudden Cardiac Arrest Study | NCT02099721

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

Arm Groups

Label	Type	Description	Intervention Names
Group A: Secondary prevention patients- device implant	Active Comparator	Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant.	Device: ICD or CRT-D Device
Group B: Secondary prevention patients - no device implant	No Intervention	Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects choose not to receive an ICD/CRT-D implant.
Group C: 1.5 Prevention patients - device implant	Active Comparator	Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant.	Device: ICD or CRT-D Device
Group D: 1.5 prevention patients - no device implant	No Intervention	Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects choose not to receive an ICD/CRT-D implant.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICD or CRT-D Device	Device	Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to the First Occurrence of a Ventricular Arrhythmia	Time to the first occurrence of an episode of true ventricular tachycardia or fibrillation 24 Month rates will be provided for the two groups used in the primary endpoint definition. However, the primary endpoint of hazard ratio is presented in Statistical Analysis 1 as a ratio between Groups A and C.	Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month VT-VF rate (as compared in the Outcome Measure table between Groups A and C).

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Time to all-cause mortality	Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month mortality rate (as compared in the Outcome Measure table between Groups C and D).

Eligibility Module

Name	Affiliation	Role
Shu Zhang	Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Churruca		Buenos Aires			Argentina
Hospital Italiano de Buenos Aires

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38519982	Derived	Zhao S, Ching CK, Huang D, Liu YB, Rodriguez-Guerrero DA, Hussin A, Kim YH, Van Dorn B, Zhou X, Singh B, Zhang S; Improve SCA Investigators. Regional disparities and risk factors of mortality among patients at high risk of sudden cardiac death in emerging countries: a nonrandomized controlled trial. BMC Med. 2024 Mar 22;22(1):130. doi: 10.1186/s12916-024-03310-5.
36736459

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group A: Secondary Prevention Patients- Device Implant	Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Nov 11, 2015	Jun 27, 2019

Arm/Group Information

ID	Title	Description
BG000	Group A: Secondary Prevention Patients- Device Implant	Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
BG001	Group B: Secondary Prevention Patients - no Device Implant	Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects choose not to receive an ICD/CRT-D implant.
BG002	Group C: 1.5 Prevention Patients - Device Implant	Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
BG003	Group D: 1.5 Prevention Patients - no Device Implant	Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects choose not to receive an ICD/CRT-D implant.
BG004	Group E: Primary, Non-1.5 Patients - Device Implant	Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
BG005	Group F: Primary, Non-1.5 Patients - no Device	Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects choose not to receive an ICD/CRT-D implant.
BG006	Total	Total of all reporting groups

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
	ParticipantsBG0001066 ParticipantsBG001127 ParticipantsBG0021068 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0001066 ParticipantsBG001127 ParticipantsBG002

Race/Ethnicity, Customized

One patient in Group F did not specify any of the above categories.

Count of Participants

Participants

Title	Denominators	Categories
Race / Ethnic Origin	ParticipantsBG0001066 ParticipantsBG001127 ParticipantsBG002

Region of Enrollment

Number

participants

Title	Denominators	Categories
Colombia	ParticipantsBG0001066 ParticipantsBG001127 ParticipantsBG002

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

Time to the First Occurrence of a Ventricular Arrhythmia

Time to the first occurrence of an episode of true ventricular tachycardia or fibrillation

24 Month rates will be provided for the two groups used in the primary endpoint definition. However, the primary endpoint of hazard ratio is presented in Statistical Analysis 1 as a ratio between Groups A and C.

Implanted 1.5 primary prevention and implanted secondary prevention patients. Since the primary objective is the hazard ratio of implanted 1.5 patients to implanted secondary patients, Groups B, D, E and F are not compared for this outcome. While not the primary endpoint, 24-month rates are provided to illustrate the underlying data.

Posted

Number

95% Confidence Interval

Estimated 24-Month VT-VF Pct of Patients

Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month VT-VF rate (as compared in the Outcome Measure table between Groups A and C).

ID	Title	Description
OG000	Group A: Secondary Prevention Patients - Device Implant	Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
OG001	Group C: 1.5 Prevention Patients - Device Implant	Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.

Units	Counts
Participants	OG0001053 OG0011068

Title

Denominators

Categories

Title	Measurements
	OG00032.5(29.3 to 36.0) OG00118.3(15.6 to 21.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	H0: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) ≤ 0.70 HA: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) > 0.70					Hazard Ratio (HR)	0.47			2-Sided	95	0.38	0.57			The hazard ratio, estimated by a Cox proportional hazard model, has time to first treated VT/VF for 1.5 Prevention in the numerator, with Secondary Prevention in the denominator.		Equivalence	The equivalence margin is a hazard ratio significantly above 0.70.

Secondary

Mortality

Time to all-cause mortality

Implanted and not-implanted 1.5 primary prevention patients. Since the secondary objective is the hazard ratio of implanted 1.5 patients to not-implanted 1.5 patients, Groups A, B, E and F are not compared for this outcome. While not the secondary endpoint, 24-month rates are provided to illustrate the underlying data.

Posted

Number

95% Confidence Interval

24 Mo. Mortality Rate (Pct. of Patients)

Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month mortality rate (as compared in the Outcome Measure table between Groups C and D).

ID	Title	Description
OG000	Group C: 1.5 Prevention Patients - Device Implant	Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
OG001	Group D: 1.5 Prevention Patients - no Device Implant

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)
EG000	Group A: Secondary Prevention Patients - Device Implanted	Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.	33	371	88	371
EG001	Group B: Secondary Prevention Patients - No Device Implanted	Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects did not receive an ICD/CRT-D implant.	0	18	0	18
EG002	Group C: 1.5 Prevention Patients - Device Implant	Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.	24	220	72	220
EG003	Group D: 1.5 Prevention Patients - No Device Implant	Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects did not receive an ICD/CRT-D implant.	24	173	37	173
EG004	Group E: 1.0 Prevention Patients - Device Implant	Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have none of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.	3	76	20	76
EG005	Group F: 1.0 Prevention Patients - No Device Implant	Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have none of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects did not receive an ICD/CRT-D implant.	4	71	10	71

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac Failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0008 events8 affected371 at risk EG0010 events0 affected18 at risk EG00230 events21 affected220 at risk EG0033 events2 affected173 at risk EG0045 events5 affected76 at risk EG0050 events0 affected71 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected371 at risk EG0010 events0 affected18 at risk EG00220 events17 affected220 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG00021 events17 affected371 at risk EG0010 events0 affected18 at risk EG0022 events2 affected220 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 events6 affected371 at risk EG0010 events0 affected18 at risk EG0027 events5 affected220 at risk EG003
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0008 events5 affected371 at risk EG0010 events0 affected18 at risk EG0024 events4 affected220 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected371 at risk EG0010 events0 affected18 at risk EG0025 events5 affected220 at risk EG003
Death	General disorders	MedDRA	Systematic Assessment	EG0005 events5 affected371 at risk EG0010 events0 affected18 at risk EG0022 events2 affected220 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events2 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0024 events4 affected220 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0023 events3 affected220 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events3 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected371 at risk EG0010 events0 affected18 at risk EG0022 events2 affected220 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events2 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events2 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0023 events1 affected220 at risk EG003
Liver abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0023 events2 affected220 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0022 events2 affected220 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0022 events1 affected220 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0022 events1 affected220 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0022 events2 affected220 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0002 events2 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0022 events2 affected220 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Lead dislodgment	Product Issues	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Medical device site abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0022 events1 affected220 at risk EG003
Medical device site infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Aortic dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Blood glucose increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Brachiocephalic vein stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Brugada syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Cardiac amyloidosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Delirium	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Device lead issue	Product Issues	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Device pacing issue	Product Issues	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Dieulafoy's vascular malformation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Dystrophic calcification	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
End stage renal disease	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Endocarditis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Heart transplant	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Hemiplegia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Hypereosinophilic syndrome	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Impaired hearing	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Implant site infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Investigation	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Liver function test abnormal	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Macular cyst	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Medical device change	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Medical device site cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Medical device site swelling	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Neurogenic tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Peripheral swelling	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Scapula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Sternal fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Sudden cardiac death	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Tinea faciei	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Wound infection staphylococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0021 events1 affected220 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Benign gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Mitral valve replacement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Steal syndrome	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Urosepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003
Ventricular flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected371 at risk EG0010 events0 affected18 at risk EG0020 events0 affected220 at risk EG003

Ancestor Terms

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003645	Death, Sudden
D003643	Death
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014474	Unconsciousness
D003244	Consciousness Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D005117	Cardiac Complexes, Premature
D001145	Arrhythmias, Cardiac
D000075224	Cardiac Conduction System Disease

Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).

These subjects choose not to receive an ICD/CRT-D implant.

ID	Term
D016757	Death, Sudden, Cardiac
D013575	Syncope
D018879	Ventricular Premature Complexes
D012769	Shock

ID	Term
D047548	Defibrillators
D004566	Electrodes
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies
D004567	Electrodes, Implanted
D019736	Prostheses and Implants