Assessment of Primary Prevention Patients Receiving An IC... | NCT02923726

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
ATP and Shock	Active Comparator	Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.	Device: Arm 1 (ATP+Shock)
Shock only	Experimental	Once tachycardia has been detected and duration met, this group would receive shock therapy only.	Device: Arm 2 (shock only)

Name	Type	Description	Arm Group Labels	Other Names
Arm 1 (ATP+Shock)	Device	Subjects will be randomized and device programmed to the respective arm.	ATP and Shock

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-Cause Shock	The incidence of all-cause shocks in subjects programmed with shocks only will be compared with subjects programmed to standard therapy (ATP and shock) to assess equivalency. All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. All shocks, appropriate and inappropriate, contributed to the evaluation of this endpoint.	5 years

Secondary Outcomes

Measure	Description	Time Frame
All-Cause Shock or Death From Any Cause	incidence of all-cause shocks or death from any cause	5 years
Appropriate Shock	incidence of first appropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Appropriate shocks contributed to the evaluation of this endpoint.

Eligibility Module

Name	Affiliation	Role
Claudio Schuger, M.D.	University of Rochester Clincal Cardiovascular Research Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Heart Center Research, LLC		Huntsville	Alabama	35801	United States
Providence Alaska Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39361311	Derived	Schuger C, Joung B, Ando K, Mont L, Lambiase PD, O'Hara GE, Jennings JM, Yung D, Boriani G, Piccini JP, Wold N, Stein KM, Daubert JP; APPRAISE ATP Investigators. Assessment of Antitachycardia Pacing in Primary Prevention Patients: The APPRAISE ATP Randomized Clinical Trial. JAMA. 2024 Nov 26;332(20):1723-1731. doi: 10.1001/jama.2024.16531.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ATP and Shock	Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.
FG001	Shock Only

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
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 2, 2016

Arm/Group Information

ID	Title	Description
BG000	ATP and Shock	Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.
BG001	Shock Only	Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.
BG002	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

Title	Measurements
	OG000129 OG001178

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		Log Rank		0.005		Hazard Ratio (HR)	0.72			2-Sided	95.9	0.57	0.92			Shock only was the reference group. Confidence interval adjusted for interim analyses.		Superiority

Secondary

All-Cause Shock or Death From Any Cause

incidence of all-cause shocks or death from any cause

All randomized subjects.

Posted

Count of Participants

Participants

5 years

ID	Title	Description
OG000	ATP and Shock	Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.
OG001	Shock Only	Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.

Units	Counts
Participants	OG000

Secondary

Appropriate Shock

incidence of first appropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Appropriate shocks contributed to the evaluation of this endpoint.

Randomized subjects.

Posted

Count of Participants

Participants

5 years

ID	Title	Description
OG000	ATP and Shock	Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.
OG001	Shock Only	Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.

Units	Counts
Participants	OG000

Secondary

Inappropriate Shock

incidence of first inappropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Inappropriate shocks contributed to the evaluation of this endpoint.

All randomized subjects.

Posted

Count of Participants

Participants

5 years

ID	Title	Description
OG000	ATP and Shock	Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.
OG001	Shock Only	Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.

Units	Counts
Participants	OG000

Secondary

All Cause Mortality

incidents of all cause mortality

All randomized subjects.

Posted

Count of Participants

Participants

5 years

ID	Title	Description
OG000	ATP and Shock	Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.
OG001	Shock Only	Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.

Units	Counts
Participants	OG000

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	ATP and Shock	Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Arm 1 (ATP+Shock): Subjects will be randomized and device programmed to the respective arm.	196	1,302	633	1,302	420	1,302
EG001	Shock Only	Once tachycardia has been detected and duration met, this group would receive shock therapy only. Arm 2 (shock only): Subjects will be randomized and device programmed to the respective arm.	175	1,293	618	1,293	448	1,293

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Unable to capture - RA PG System	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Elevated threshold - RV PG System	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Impedance Out of Range - RV PG System	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Undersensing - Defibrillation - PG System	Product Issues	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0010 events0 affected1,293 at risk
Elevated DFT - Defibrillation - PG System	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Inappropriate Tachy Therapy - SVT - PG System Therapy	Product Issues	Systematic Assessment	EG00014 events13 affected1,302 at risk EG00118 events17 affected1,293 at risk
Infection (>30 days post-implant) - PG System - Subject related	Infections and infestations	Systematic Assessment	EG0009 events9 affected1,302 at risk EG0017 events7 affected1,293 at risk
Twiddler's Syndrome - PG System - Subject related	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0010 events0 affected1,293 at risk
Migration - PG System - Subject related	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0010 events0 affected1,293 at risk
Post-surgical wound discomfort/bruising/swelling	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Post-surgical infection (<=30 days post-implant)	Injury, poisoning and procedural complications	Systematic Assessment	EG0005 events5 affected1,302 at risk EG0013 events3 affected1,293 at risk
Chest pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0010 events0 affected1,293 at risk
Hematoma - Pocket (<=30 days post-implant)	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Death-Unknown - PG System - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Deep Vein Thrombosis - PG System - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Unable to capture - RA Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Conductor coil fracture - RA Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Myocardial perforation post-implant - RA Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Dislodgment - Multiple signs - RA Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Dislodgment - No reported signs - RA Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Thrombosis - Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Tricuspid Valve Damage RV lead - Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Unable to capture - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Extracardiac stimulation - RV Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Conductor coil fracture - RV Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Myocardial perforation post-implant - RV Lead	Product Issues	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0012 events2 affected1,293 at risk
Dislodgment - Unable to capture - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0012 events2 affected1,293 at risk
Dislodgment - Elevated threshold -RV Lead	Product Issues	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0013 events3 affected1,293 at risk
Dislodgment - Oversensing - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Dislodgment - Multiple signs - RV Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Dislodgment - No reported signs - RV Lead	Product Issues	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0011 events1 affected1,293 at risk
Impedance Out of Range - Defibrillation lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Pneumothorax - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Pericardial effusion - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events1 affected1,302 at risk EG0012 events2 affected1,293 at risk
3rd degree AV block	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0014 events4 affected1,293 at risk
Pulseless Electrical Activity (PEA)	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Ventricular Fibrillation (VF)	Cardiac disorders	Systematic Assessment	EG00025 events24 affected1,302 at risk EG00130 events27 affected1,293 at risk
Ventricular Tachycardia (VT)/Monomorphic VT	Cardiac disorders	Systematic Assessment	EG00071 events43 affected1,302 at risk EG00157 events49 affected1,293 at risk
Nonsustained Ventricular Tachycardia (NSVT)	Cardiac disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0013 events3 affected1,293 at risk
Atrial Fibrillation (AF)	Cardiac disorders	Systematic Assessment	EG00057 events43 affected1,302 at risk EG00184 events68 affected1,293 at risk
Atrial Flutter	Cardiac disorders	Systematic Assessment	EG0008 events8 affected1,302 at risk EG0015 events5 affected1,293 at risk
Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)	Cardiac disorders	Systematic Assessment	EG0006 events5 affected1,302 at risk EG0017 events6 affected1,293 at risk
Premature Ventricular Contractions (PVC)	Cardiac disorders	Systematic Assessment	EG0004 events4 affected1,302 at risk EG0018 events7 affected1,293 at risk
SVT vs VT - Arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
VF with Syncope - Arrhythmia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
VT with Syncope - Arrhythmia	Cardiac disorders	Systematic Assessment	EG0009 events9 affected1,302 at risk EG00115 events15 affected1,293 at risk
Syncope - Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0012 events2 affected1,293 at risk
Dizziness - Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Chest pain - Heart failure	Cardiac disorders	Systematic Assessment	EG0008 events8 affected1,302 at risk EG0017 events5 affected1,293 at risk
Dyspnea - Heart failure	Cardiac disorders	Systematic Assessment	EG00044 events34 affected1,302 at risk EG00158 events48 affected1,293 at risk
Peripheral edema - Heart failure	Cardiac disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0017 events7 affected1,293 at risk
Pulmonary edema - Heart failure	Cardiac disorders	Systematic Assessment	EG0004 events4 affected1,302 at risk EG0014 events4 affected1,293 at risk
Fatigue - Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0012 events2 affected1,293 at risk
Renal insufficiency/failure - Heart failure	Cardiac disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0014 events4 affected1,293 at risk
Dehydration - Heart failure	Cardiac disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0010 events0 affected1,293 at risk
Gastrointestinal - Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Hypotension - Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0013 events3 affected1,293 at risk
Pleural Effusion - Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0018 events7 affected1,293 at risk
Cardiac medication complication - Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Heart failure symptoms - Unspecified	Cardiac disorders	Systematic Assessment	EG00055 events46 affected1,302 at risk EG00165 events56 affected1,293 at risk
Multiple heart failure symptoms	Cardiac disorders	Systematic Assessment	EG000248 events171 affected1,302 at risk EG001285 events160 affected1,293 at risk
Hypertension - Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0012 events1 affected1,293 at risk
Heart transplant - Heart Failure Patient Condition - Cardiovascular	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Multi-system failure - Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Hypotension/Orthostatic Hypotension	Vascular disorders	Systematic Assessment	EG00014 events13 affected1,302 at risk EG00113 events12 affected1,293 at risk
Hypertension/Hypertensive Crisis	Vascular disorders	Systematic Assessment	EG0005 events5 affected1,302 at risk EG0013 events3 affected1,293 at risk
Cardiogenic shock	Cardiac disorders	Systematic Assessment	EG00018 events17 affected1,302 at risk EG0019 events9 affected1,293 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG00020 events20 affected1,302 at risk EG00120 events20 affected1,293 at risk
Myocardial infarction	Vascular disorders	Systematic Assessment	EG00034 events31 affected1,302 at risk EG00127 events26 affected1,293 at risk
Coronary Artery Disease	Vascular disorders	Systematic Assessment	EG00025 events22 affected1,302 at risk EG00123 events22 affected1,293 at risk
Peripheral vascular disease	Vascular disorders	Systematic Assessment	EG00015 events13 affected1,302 at risk EG00120 events15 affected1,293 at risk
Aortic stenosis	Cardiac disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0012 events2 affected1,293 at risk
Mitral stenosis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Mitral regurgitation	Cardiac disorders	Systematic Assessment	EG0005 events5 affected1,302 at risk EG0018 events7 affected1,293 at risk
Tricuspid regurgitation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Valvular damage/Valvular insufficiency	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0014 events4 affected1,293 at risk
Syncope	General disorders	Systematic Assessment	EG00020 events17 affected1,302 at risk EG00125 events18 affected1,293 at risk
Dizziness	General disorders	Systematic Assessment	EG0004 events4 affected1,302 at risk EG0012 events2 affected1,293 at risk
Chest pain - Ischemic	Vascular disorders	Systematic Assessment	EG00018 events18 affected1,302 at risk EG00119 events18 affected1,293 at risk
Chest pain - Other	General disorders	Systematic Assessment	EG00035 events28 affected1,302 at risk EG00134 events30 affected1,293 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00014 events14 affected1,302 at risk EG0018 events8 affected1,293 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0012 events1 affected1,293 at risk
Fatigue/Weakness	General disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0012 events2 affected1,293 at risk
Multiple symptoms	General disorders	Systematic Assessment	EG0008 events8 affected1,302 at risk EG00116 events16 affected1,293 at risk
Abdominal Aortic Aneurysm - Patient Condition - Cardiovascular	Cardiac disorders	Systematic Assessment	EG0004 events3 affected1,302 at risk EG00112 events10 affected1,293 at risk
Amyloidosis - Patient Condition - Cardiovascular	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Aortic Abdominal Aneurysm - Patient Condition - Cardiovascular	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Cardiac Sarcoidosis - Patient Condition - Cardiovascular	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0012 events2 affected1,293 at risk
Internal Carotid Artery (ICA) - Patient Condition - Cardiovascular	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Thoracic Aortic Aneurysm - Patient Condition - Cardiovascular	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Transient Ischemic Attack (TIA)	Vascular disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0013 events3 affected1,293 at risk
Cerebrovascular Accident (CVA) - unspecifed	Vascular disorders	Systematic Assessment	EG00015 events15 affected1,302 at risk EG00121 events20 affected1,293 at risk
Deep Vein Thrombosis (DVT)	Vascular disorders	Systematic Assessment	EG00011 events11 affected1,302 at risk EG0014 events4 affected1,293 at risk
Pulmonary Embolism (PE)	Vascular disorders	Systematic Assessment	EG00010 events10 affected1,302 at risk EG0017 events7 affected1,293 at risk
Distal thromboemboli	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0012 events2 affected1,293 at risk
Intracardiac thrombus	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Arterial/venous thrombolytic event	Vascular disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0011 events1 affected1,293 at risk
Cerebrovascular Accident (CVA) - ischemic	Vascular disorders	Systematic Assessment	EG0006 events6 affected1,302 at risk EG00115 events14 affected1,293 at risk
Cerebrovascular Accident (CVA) - hemorrhagic	Vascular disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0011 events1 affected1,293 at risk
Pericardial effusion - Unrelated (non study) procedure or device	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0013 events3 affected1,293 at risk
Pericarditis - Unrelated (non study) procedure or device	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Hematoma - Unrelated (non study) procedure or device	Vascular disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0010 events0 affected1,293 at risk
Hemorrhage - Unrelated (non study) procedure or device	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0012 events2 affected1,293 at risk
Pneumothorax - Unrelated (non study) procedure or device	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0012 events2 affected1,293 at risk
Infection - Unrelated (non study) procedure or device	Infections and infestations	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0012 events2 affected1,293 at risk
Pleural Effusion - Unrelated (non study) procedure or device	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0011 events1 affected1,293 at risk
Adverse reaction - General	General disorders	Systematic Assessment	EG0005 events5 affected1,302 at risk EG0013 events3 affected1,293 at risk
Adverse reaction - Respiratory	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0012 events2 affected1,293 at risk
Adverse reaction - Allergic reaction	General disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Vasovagal reaction	General disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00017 events14 affected1,302 at risk EG00122 events17 affected1,293 at risk
Adverse reaction - Medication	General disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Alcohol Dependency - Patient Condition - Non-Cardiovascular	General disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
General Discomfort - Patient Condition - Non-Cardiovascular	General disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Death	General disorders	Systematic Assessment	EG00032 events32 affected1,302 at risk EG00124 events24 affected1,293 at risk
Systemic infection	Infections and infestations	Systematic Assessment	EG00048 events46 affected1,302 at risk EG00146 events38 affected1,293 at risk
Fever and/or Virus	Infections and infestations	Systematic Assessment	EG0008 events8 affected1,302 at risk EG0018 events8 affected1,293 at risk
Physical trauma	General disorders	Systematic Assessment	EG00011 events11 affected1,302 at risk EG0018 events7 affected1,293 at risk
Abnormal laboratory values	General disorders	Systematic Assessment	EG00017 events15 affected1,302 at risk EG00115 events15 affected1,293 at risk
Localized Infection	Infections and infestations	Systematic Assessment	EG00015 events13 affected1,302 at risk EG00111 events9 affected1,293 at risk
Hematological	Blood and lymphatic system disorders	Systematic Assessment	EG00015 events14 affected1,302 at risk EG00125 events23 affected1,293 at risk
Neurological	Nervous system disorders	Systematic Assessment	EG00025 events19 affected1,302 at risk EG00127 events21 affected1,293 at risk
Gastrointestinal	Gastrointestinal disorders	Systematic Assessment	EG00099 events82 affected1,302 at risk EG001102 events69 affected1,293 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG000110 events94 affected1,302 at risk EG001113 events94 affected1,293 at risk
Abominal Pseudoanerysm with active extravasion - Whole Body	General disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Obesity - Whole Body	General disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
PICC Line Malfunction - Whole Body	General disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Sternal Wire Protrusion s/p CABG repair - Whole Body	General disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Genitourinary	Renal and urinary disorders	Systematic Assessment	EG00022 events18 affected1,302 at risk EG00128 events23 affected1,293 at risk
Renal	Renal and urinary disorders	Systematic Assessment	EG00045 events34 affected1,302 at risk EG00152 events47 affected1,293 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00047 events44 affected1,302 at risk EG00142 events33 affected1,293 at risk
Psychological	Psychiatric disorders	Systematic Assessment	EG0007 events7 affected1,302 at risk EG0018 events8 affected1,293 at risk
Integumentary	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0009 events9 affected1,302 at risk EG00110 events8 affected1,293 at risk
Head, eyes, ears, nose, throat (HEENT)	General disorders	Systematic Assessment	EG00012 events9 affected1,302 at risk EG0019 events8 affected1,293 at risk
Endocrine	Endocrine disorders	Systematic Assessment	EG00011 events10 affected1,302 at risk EG00116 events15 affected1,293 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG00063 events50 affected1,302 at risk EG00137 events33 affected1,293 at risk
Multi-system failure	General disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0014 events4 affected1,293 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Oversensing - RA PG System	Product Issues	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0011 events1 affected1,293 at risk
Undersensing - RA PG System	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Oversensing - RV PG System	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Impedance Out of Range - RV PG System	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Oversensing - Defibrillation - PG System	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Inappropriate Tachy Therapy - SVT - PG System Therapy	Product Issues	Systematic Assessment	EG00025 events20 affected1,302 at risk EG00157 events40 affected1,293 at risk
Early ERI - Premature declaration - PG System Therapy	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Pacemaker Mediated Tachycardia - PG System Therapy	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0014 events4 affected1,293 at risk
Inadequate healing of incision site - PG System - Subject related	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Psychological effect due to device therapy - PG System - Subject related	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Twiddler's Syndrome - PG System - Subject related	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Migration - PG System - Subject related	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Complex Regional Pain Syndrome and Frozen Shoulder - PG System - Patient Related	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Pain at Site - PG System - Patient Related	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Post-surgical wound discomfort/bruising/swelling	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0014 events4 affected1,293 at risk
Post-surgical infection (<=30 days post-implant)	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0013 events3 affected1,293 at risk
Hematoma - Pocket (<=30 days post-implant)	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0013 events3 affected1,293 at risk
Thromboembolic events	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0010 events0 affected1,293 at risk
Oversensing - RA Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0012 events2 affected1,293 at risk
Undersensing - RA Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Unable to capture - RA Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Elevated threshold - RA Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Extracardiac stimulation - RA Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Conductor coil fracture - RA Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Dislodgment - Elevated threshold - RA Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Dislodgment - Multiple signs - RA Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Dislodgment - No reported signs - RA Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Oversensing - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Elevated threshold - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Extracardiac stimulation - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Conductor coil fracture - RV Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Insulation breach - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Dislodgment - Unable to capture - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Dislodgment - Elevated threshold -RV Lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0014 events3 affected1,293 at risk
Dislodgment - Undersensing - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Dislodgment - No reported signs - RV Lead	Product Issues	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0010 events0 affected1,293 at risk
Impedance Out of Range - Defibrillation lead	Product Issues	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Pneumothorax - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Pericardial effusion - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Attempted coronary sinus lead placement - Lead - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
3rd degree AV block	Cardiac disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0010 events0 affected1,293 at risk
Sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0014 events4 affected1,293 at risk
Ventricular Fibrillation (VF)	Cardiac disorders	Systematic Assessment	EG00023 events19 affected1,302 at risk EG00132 events28 affected1,293 at risk
Ventricular Tachycardia (VT)/Monomorphic VT	Cardiac disorders	Systematic Assessment	EG000150 events93 affected1,302 at risk EG001176 events117 affected1,293 at risk
Nonsustained Ventricular Tachycardia (NSVT)	Cardiac disorders	Systematic Assessment	EG000178 events153 affected1,302 at risk EG001178 events150 affected1,293 at risk
Atrial Fibrillation (AF)	Cardiac disorders	Systematic Assessment	EG000110 events100 affected1,302 at risk EG001120 events96 affected1,293 at risk
Atrial Flutter	Cardiac disorders	Systematic Assessment	EG00010 events9 affected1,302 at risk EG0019 events9 affected1,293 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0004 events3 affected1,302 at risk EG0012 events2 affected1,293 at risk
Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)	Cardiac disorders	Systematic Assessment	EG00093 events67 affected1,302 at risk EG00192 events53 affected1,293 at risk
Junctional ectopic rhythm	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Premature Ventricular Contractions (PVC)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0013 events3 affected1,293 at risk
Arrhythmia Not Specified - Arrhythmia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Intraventricular Conduction Disorder - Arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Prolonged Q-T Interval - Arrhythmia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Tachycardia patient reported - Arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
VF with Syncope - Arrhythmia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0012 events2 affected1,293 at risk
VT with Syncope - Arrhythmia	Cardiac disorders	Systematic Assessment	EG0008 events7 affected1,302 at risk EG00111 events10 affected1,293 at risk
Dizziness - Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0012 events2 affected1,293 at risk
Chest pain - Heart failure	Cardiac disorders	Systematic Assessment	EG0002 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Dyspnea - Heart failure	Cardiac disorders	Systematic Assessment	EG0006 events6 affected1,302 at risk EG00113 events11 affected1,293 at risk
Peripheral edema - Heart failure	Cardiac disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0011 events1 affected1,293 at risk
Pulmonary edema - Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Renal insufficiency/failure - Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Dehydration - Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Heart failure symptoms - Unspecified	Cardiac disorders	Systematic Assessment	EG0006 events6 affected1,302 at risk EG00110 events9 affected1,293 at risk
Multiple heart failure symptoms	Cardiac disorders	Systematic Assessment	EG00013 events13 affected1,302 at risk EG00116 events16 affected1,293 at risk
Hypotension/Orthostatic Hypotension	Vascular disorders	Systematic Assessment	EG0008 events8 affected1,302 at risk EG0016 events6 affected1,293 at risk
Hypertension/Hypertensive Crisis	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0012 events2 affected1,293 at risk
Myocardial infarction	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Coronary Artery Disease	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Aortic stenosis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Mitral regurgitation	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Syncope	General disorders	Systematic Assessment	EG00021 events20 affected1,302 at risk EG00118 events17 affected1,293 at risk
Dizziness	General disorders	Systematic Assessment	EG00011 events10 affected1,302 at risk EG00116 events15 affected1,293 at risk
Chest pain - Ischemic	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0011 events1 affected1,293 at risk
Chest pain - Other	General disorders	Systematic Assessment	EG0007 events7 affected1,302 at risk EG0014 events4 affected1,293 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0015 events5 affected1,293 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Multiple symptoms	General disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Transient Ischemic Attack (TIA)	Vascular disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0010 events0 affected1,293 at risk
Deep Vein Thrombosis (DVT)	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Intracardiac thrombus	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Arterial/venous thrombolytic event	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Pericarditis - Unrelated (non study) procedure or device	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Hematoma - Unrelated (non study) procedure or device	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Hemorrhage - Unrelated (non study) procedure or device	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Infection - Unrelated (non study) procedure or device	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Puncture Site Ulcer - Unrelated Procedure/Device	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Adverse reaction - General	General disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Adverse reaction - Hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events2 affected1,302 at risk EG0010 events0 affected1,293 at risk
Adverse reaction - Medication	General disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Abdominal Pain - Patient Condition - Non-Cardiovascular	General disorders	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0010 events0 affected1,293 at risk
Dehydration - Patient Condition - Non-Cardiovascular	General disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Systemic infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,302 at risk EG0012 events2 affected1,293 at risk
Fever and/or Virus	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Physical trauma	General disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0011 events1 affected1,293 at risk
Abnormal laboratory values	General disorders	Systematic Assessment	EG0005 events3 affected1,302 at risk EG0014 events3 affected1,293 at risk
Localized Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk
Hematological	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events1 affected1,302 at risk EG0012 events2 affected1,293 at risk
Neurological	Nervous system disorders	Systematic Assessment	EG0004 events4 affected1,302 at risk EG0011 events1 affected1,293 at risk
Gastrointestinal	Gastrointestinal disorders	Systematic Assessment	EG0005 events4 affected1,302 at risk EG0012 events2 affected1,293 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0017 events6 affected1,293 at risk
Genitourinary	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected1,302 at risk EG0012 events2 affected1,293 at risk
Renal	Renal and urinary disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0013 events3 affected1,293 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0013 events3 affected1,293 at risk
Psychological	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0012 events1 affected1,293 at risk
Head, eyes, ears, nose, throat (HEENT)	General disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0012 events2 affected1,293 at risk
Endocrine	Endocrine disorders	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0011 events1 affected1,293 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0003 events3 affected1,302 at risk EG0011 events1 affected1,293 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,302 at risk EG0011 events1 affected1,293 at risk

COVID-19 led to an increase in missed visits, late visits, withdrawals and several site personnel changes.

Additional ATP programming options were not evaluated, only the effect of a single ATP burst of 8 pulses at 88% cycle length.

The differential delay to shock between arms due to ATP (~3 seconds) may have led to more shocks in the Shock Only arm.

The utility of ATP in other primary prevention indications was not assessed.

Certain Agreements

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