BIO|MASTER.Ilivia Family / Plexa | NCT02774616

Status Module

Label	Type	Description	Intervention Names
Ilivia ICD Family	Other	Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting	Device: Ilivia ICD Family
Plexa ICD lead	Other	Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting	Device: Plexa ICD lead
Ilivia ICD and Plexa lead	Other	Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting	Device: Ilivia ICD Family Device: Plexa ICD lead

Name	Type	Description	Arm Group Labels	Other Names
Ilivia ICD Family	Device	pre-defined device programming, measurements and follow-up schedule	Ilivia ICD Family Ilivia ICD and Plexa lead

Measure	Description	Time Frame
Ilivia Family Related SADE-free Rate Through 3 Months	This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device	3 months
Plexa Related SADE-free Rate Through 6 Months	This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead	6 months

Measure	Description	Time Frame
Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up	Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by "ATP-one-shot", the percentage of patients with at least one successful termination will be determined	6 months

Eligibility Module

Name	Affiliation	Role
Christian Sticherling, Prof. Dr.	Universitätsspital Basel	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Liverpool Hospital		Liverpool			Australia
Nambour General Hospital

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ilivia ICD Family	Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule
FG001	Plexa ICD Lead

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	Yes	No	No	Study Protocol	Nov 14, 2016	Jul 18, 2018

Arm/Group Information

ID	Title	Description
BG000	Ilivia ICD Family	Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule
BG001	Plexa ICD Lead	Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting Plexa ICD lead: predefined follow-up schedule
BG002	Ilivia ICD and Plexa ICD Lead	Implant of the new Ilivia ICD Family and the new Plexa ICD lead. Device measurements, pre-defined programming and Adverse Event Reporting Pre-defined device programming, measurements and follow-up schedule
BG003	Total	Total of all reporting groups

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

Ilivia Family Related SADE-free Rate Through 3 Months

This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device

These are all patients who either had a primary endpoint or who had reached 3 months of follow-up, or both.

Posted

Count of Participants

Participants

3 months

ID	Title	Description
OG000	Ilivia Arm	This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined
OG001	Ilivia ICD and Plexa ICD Lead	This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined

Units	Counts
Participants	OG00092 OG00112

Title

Denominators

Categories

Title	Measurements
	OG00091 OG00112

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	Serious Adverse Device Effects (SADE) possibly or securely related to the Ilivia ICD family until the 3- month follow-up are counted for this primary endpoint. The following hypothesis has been defined: Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant > 90.0%	exact binomial		0.0004														Non-Inferiority	A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.

Primary

Plexa Related SADE-free Rate Through 6 Months

This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead

These are all patients who either had an endpoint or who reached 6 months of follow-up.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Plexa Arm	This endpoint was evaluated in patients of the Plexa arm and of the Ilivia ICD and Plexa ICD lead arm combined
OG001	Ilivia ICD and Plexa ICD Lead	This endpoint was evaluated in patients of the Plexa arm and of the Ilivia ICD and Plexa ICD lead arm combined

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up

Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by "ATP-one-shot", the percentage of patients with at least one successful termination will be determined

Only 5 patients had spontaneous ventricular arrhythmia detected in the VF zone.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Ilivia Arm	This endpoint was evaluated in patients of the Iliva arm with spontaneous ventricular arrhythmia detected in the VF zone

Units	Counts
Participants	OG000

Secondary

Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up

The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate

Patients in whom this endpoint was not evaluated did not attend the 3-months follow-up or the data were not recorded

Posted

Count of Participants

Participants

3 months

ID	Title	Description
OG000	Plexa Arm	This endpoint was evaluated in patients of the Plexa arm only

Units	Counts
Participants	OG000145

Secondary

Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up

The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate

Patients in whom this endpoint was not evaluated did not attend the 3-months follow-up or the data were not recorded

Posted

Count of Participants

Participants

3 months

ID	Title	Description
OG000	Plexa Arm	This endpoint was evaluated in patients of the Plexa arm only

Units	Counts
Participants	OG000150

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Adrenal insufficiency	Endocrine disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Adverse drug reaction	General disorders	Systematic Assessment	EG0003 events3 affected111 at risk EG0016 events6 affected183 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Aortic valve disease	Cardiac disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0007 events6 affected111 at risk EG0015 events5 affected183 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0012 events1 affected183 at risk
Autoimmune disorder	Immune system disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Bronchial infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events2 affected183 at risk
Cardiogenic shock	Vascular disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected183 at risk
Cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Cataract	Eye disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Chest pain - cardiac	Cardiac disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
COPD	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected111 at risk EG0013 events3 affected183 at risk
Coronary artery disorders	Cardiac disorders	Systematic Assessment	EG0002 events1 affected111 at risk EG0010 events0 affected183 at risk
Death NOS	General disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
decompensated heart failure/ cardiac decompensation	Cardiac disorders	Systematic Assessment	EG00011 events9 affected111 at risk EG0017 events6 affected183 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Delirium	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Device issue	General disorders	Systematic Assessment	EG0008 events8 affected111 at risk EG0019 events9 affected183 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Ejection fraction decreased	Investigations	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Endocarditis infective	Infections and infestations	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Eye disorders NEC	Eye disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Gastrointestinal disorders NEC	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected111 at risk EG0013 events3 affected183 at risk
General disorders and administration site conditions NEC	General disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Heart failure	Cardiac disorders	Systematic Assessment	EG0003 events3 affected111 at risk EG00111 events7 affected183 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Hepatic failure	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Hypertensive crisis	Vascular disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Hyperthyroidism	Endocrine disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0004 events4 affected111 at risk EG0011 events1 affected183 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Inappropriate phrenic nerve stimulation	General disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected183 at risk
Infections and infestations NEC	Infections and infestations	Systematic Assessment	EG0002 events2 affected111 at risk EG0012 events2 affected183 at risk
Injury, poisoning and procedural complications NEC	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Investigations NEC	Investigations	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Metabolism and nutrition disorders NEC	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Mitral valve disease	Cardiac disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Multi-organ failure	General disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Musculoskeletal and connective tissue disorder NEC	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected111 at risk EG0011 events1 affected183 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Nervous system disorders NEC	Nervous system disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected183 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Pain	General disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Paroxysmal atrial tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Pericardial effusion	Cardiac disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected183 at risk
Pericardial tamponade	Cardiac disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected183 at risk
Peripheral arterial occlusive disease	Vascular disorders	Systematic Assessment	EG0002 events1 affected111 at risk EG0011 events1 affected183 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0015 events3 affected183 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0003 events2 affected111 at risk EG0011 events1 affected183 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Psychiatric disorders NEC	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Renal and urinary disorders NEC	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Renal calculi	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected111 at risk EG0014 events4 affected183 at risk
Reproductive system and breast disorders NEC	Reproductive system and breast disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected183 at risk
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected183 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Sick sinus syndrome	Cardiac disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Skin and subcutaneous tissue disorders NEC	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Skin infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Sleep apnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Stroke	Nervous system disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected183 at risk
Supraventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Thromboembolic event	Vascular disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Upper respiratory infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Ventricular fibrillation	Cardiac disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0013 events3 affected183 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Worsening Heart Failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0013 events3 affected183 at risk
Wound complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events2 affected183 at risk
Wound infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Adverse drug reaction	General disorders	Systematic Assessment	EG0004 events4 affected111 at risk EG0017 events7 affected183 at risk
Allergic reaction	Immune system disorders	Systematic Assessment	EG0004 events4 affected111 at risk EG0012 events2 affected183 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0003 events3 affected111 at risk EG0013 events3 affected183 at risk
COPD	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0012 events2 affected183 at risk
decompensated heart failure/ cardiac decompensation	Cardiac disorders	Systematic Assessment	EG0003 events2 affected111 at risk EG0011 events1 affected183 at risk
Device issue	General disorders	Systematic Assessment	EG0009 events8 affected111 at risk EG0015 events5 affected183 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0013 events3 affected183 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected183 at risk
Eye disorders NEC	Eye disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events2 affected183 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Gastrointestinal disorders NEC	Gastrointestinal disorders	Systematic Assessment	EG0002 events1 affected111 at risk EG0012 events1 affected183 at risk
General disorders and administration site conditions NEC	General disorders	Systematic Assessment	EG0003 events3 affected111 at risk EG0011 events1 affected183 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events1 affected183 at risk
Hematoma	Vascular disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events2 affected183 at risk
Hepatobiliary disorders NEC	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Hyperthyroidism	Endocrine disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected183 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Inappropriate phrenic nerve stimulation	General disorders	Systematic Assessment	EG00018 events12 affected111 at risk EG00112 events7 affected183 at risk
Infections and infestations NEC	Infections and infestations	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected183 at risk
Intraoperative venous injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Investigations NEC	Investigations	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected183 at risk
Metabolism and nutrition disorders NEC	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Musculoskeletal and connective tissue disorder NEC	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0014 events3 affected183 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0003 events3 affected111 at risk EG0012 events2 affected183 at risk
Nervous system disorders NEC	Nervous system disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0012 events2 affected183 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Pain	General disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events2 affected183 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0013 events3 affected183 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Prostate infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected111 at risk EG0010 events0 affected183 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Respiratory, thoracic and mediastinal disorders NEC	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Restlessness	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Rhinitis infective	Infections and infestations	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Skin and subcutaneous tissue disorders NEC	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Sleep apnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Stomach pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected183 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected183 at risk
Thromboembolic event	Vascular disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected183 at risk
Unevaluable event	General disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Upper respiratory infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected111 at risk EG0012 events2 affected183 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events2 affected183 at risk
Vascular disorders NEC	Vascular disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected183 at risk
Ventricular fibrillation	Cardiac disorders	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected183 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0004 events4 affected111 at risk EG0014 events4 affected183 at risk
Worsening Heart Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk
Wound complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 events4 affected111 at risk EG0013 events3 affected183 at risk
Wound dehiscence	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected183 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D000075224	Cardiac Conduction System Disease
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ilivia ICD Family	Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule	6	111	48	111	52	111
EG001	Plexa ICD Lead	Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting Plexa ICD lead: predefined follow-up schedule	6	183	56	183	49	183