Evaluation of Automatic Threshold Algorithms | NCT02097290

ID	Type	Description	Link
IDE# G130241	Other Identifier	FDA

Label	Type	Description	Intervention Names
CRT-D	Experimental	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated	Device: CRT-D

Name	Type	Description	Arm Group Labels	Other Names
CRT-D	Device	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated	CRT-D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate	Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.	3 months
The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.	Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: \|commanded threshold - core lab determined threshold\| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or \|commanded threshold - core lab determined threshold\| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.	1-month and 3-month follow-up visits
The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.	Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold\| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or \|commanded threshold - core lab determined threshold\| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.

Secondary Outcomes

Measure	Description	Time Frame
RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome	This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: A device-determined threshold A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173
Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead
Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead
Subjects who are willing and capable of providing informed consent to undergo a device implant procedure, and to participate in all testing and follow-ups defined in this protocol
Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

Subjects who have an implanted multipolar (>2poles) left ventricular lead or who will receive a multipolar (>2poles) left ventricular lead
Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead
Subjects for whom a RV defibrillation lead manufactured by St. Jude Medical or Biotronik is implanted, is planned to be implanted, or has been abandoned
Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949
Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T
Subjects with a RV or LV lead revision or extraction within 30 days of enrollment
Subjects with an implanted lead that is planned to be extracted during the study implant procedure
Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned
Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned
Subjects preexisting unipolar pacemaker that will not be explanted/abandoned
Subjects with a life expectancy less than 6 months
Subjects with a prosthetic mechanical tricuspid heart valve
Women of childbearing age who are pregnant or plan to become pregnant. NOTE: women of childbearing potential with an uncertain pregnancy status must have a negative pregnancy test within 7 days prior to enrollment. Pregnancy tests are required as part of standard routing clinical practice at all centers whenever female patients are exposed to x-ray radiation. Since this protocol does not require any exposure of the female patients to x-ray and x-ray exposure is part of the clinical procedure, it is the responsibility of the investigators to ensure that pregnant females will not be exposed to x-ray at any time
Subject enrolled in a concurrent study, except national/governmental registries that do not require a signed informed consent form, without the written approval from Boston Scientific
Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center

Name	Affiliation	Role
Kenneth Ellenbogen, MD	Virginia Commonwealth University Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Glendale Adventist Medical Center		Glendale	California	91204	United States
Danbury Hospital

PubMed Identifier	Type	Citation	Retractions
40296252	Derived	Friedman DJ, Burr J, Jones PW, Wold N. Automatic Threshold Function With Left Bundle Branch Area Versus Traditional Right Ventricular Lead Placement. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1419-1422. doi: 10.1111/jce.16696. Epub 2025 Apr 28.

ID	Title	Description
FG000	CRT-D	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

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

Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate

Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.

Implant + Attempt Subjects

Posted

Number

95% Confidence Interval

Percentage of participants

3 months

ID	Title	Description
OG000	CRT-D	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Units	Counts
Participants	OG000210

Title

Denominators

Categories

Title	Measurements
	OG00084.2(79.5 to NA)Only lower confidence interval limit was considered for end point result

Primary

The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.

Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: |commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.

A total of 288 paired datasets (from 171 unique subjects in whom RVAT threshold was available), each dataset consisting of a commanded RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

Posted

Number

95% Confidence Interval

percentage of commanded RVAT thresholds

1-month and 3-month follow-up visits

Commanded RVAT thresholds paired dataset

ID	Title	Description
OG000	CRT-D	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Primary

The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.

Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.

A total of 324 paired datasets (from 182 unique subjects in whom LVAT threshold was available), each dataset consisting of a commanded LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

Posted

Number

95% Confidence Interval

Percentage of commanded LVAT thresholds

1-month and 3-month follow up visits

Commanded LVAT thresholds-paired dataset

ID	Title	Description
OG000	CRT-D	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Primary

The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold

Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:|Ambulatory threshold - ECG threshold| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or |Ambulatory threshold - ECG threshold| ≤ 1.0 V; if the ECG threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.

A total of 314 paired datasets (from 183 unique subjects in whom RVAT threshold was available), each dataset consisting of an ambulatory RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

Posted

Number

95% Confidence Interval

Percentage of RVAT ambulatory thresholds

1-month and 3-month follow up visits

RVAT ambulatory threshold paired dataset

ID	Title	Description
OG000	CRT-D	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Primary

The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold

Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: |Ambulatory threshold - ECG threshold| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.

A total of 300 paired datasets (from 175 unique subjects in whom LVAT threshold was available), each dataset consisting of a ambulatory LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

Posted

Number

95% Confidence Interval

Percentage of accurate threshold

1-month and 3-month follow up visits

LVAT ambulatory threshold paired dataset

ID	Title	Description
OG000	CRT-D	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Secondary

RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome

This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test:

A device-determined threshold
A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests
A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above.

A total of 157 unique subjects in whom a paired RVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an RVAT threshold test outcome and core lab determined threshold test outcome.

Posted

Number

95% Confidence Interval

percentage of appropriate outcome

3-month follow up visit

ID	Title	Description
OG000	CRT-D	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Secondary

LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome

This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test:

A device-determined threshold
A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests
A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above.

A total of 182 unique subjects in whom a paired LVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an LVAT threshold test outcome and core lab determined threshold test outcome.

Posted

Number

95% Confidence Interval

percentage of appropriate outcome

3-month follow up visit

ID	Title	Description
OG000	CRT-D	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abnormal Laboratory Values	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Skin rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Adverse Reaction - Hypotension	Cardiac disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Adverse Reaction - Respiratory	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected210 at risk
Arterial/Venous Trombolytic Event	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Atrial Fibrillation (Af)	Cardiac disorders	Systematic Assessment	EG0008 events7 affected210 at risk
Atrial Flutter	Cardiac disorders	Systematic Assessment	EG0005 events5 affected210 at risk
Atrial Tachyarrhythmias	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0004 events4 affected210 at risk
Cardiac Arrest	Cardiac disorders	Systematic Assessment	EG0008 events8 affected210 at risk
Cardiogenic Shock	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Cerebrovascular Accident (Cva)	Vascular disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Chest Pain - Ischemic	Cardiac disorders	Systematic Assessment	EG0003 events3 affected210 at risk
Chest Pain - Other	Cardiac disorders	Systematic Assessment	EG0003 events3 affected210 at risk
Copd Exacerbation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events3 affected210 at risk
Coronary Artery Disease	Cardiac disorders	Systematic Assessment	EG0002 events1 affected210 at risk
Coronary Venous Perforation Without Tamponade	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Dislodgment - Elevated Threshold - Rv	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Dislodgment - Extracardiac Stimulation - Lv	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Dislodgment - Multiple Signs - Rv	Cardiac disorders	Systematic Assessment	EG0002 events1 affected210 at risk
Dislodgment - No Reported Signs - Lv	Cardiac disorders	Systematic Assessment	EG0003 events3 affected210 at risk
Dislodgment - No Reported Signs - Ra	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Dislodgment - Unable To Capture - Lv	Cardiac disorders	Systematic Assessment	EG0003 events3 affected210 at risk
Dislodgment - Unable To Capture - Ra	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Dizziness	General disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Dyspnea - Heart Failure	Cardiac disorders	Systematic Assessment	EG00013 events9 affected210 at risk
Elevated Threshold - Lv	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Endocrine	Endocrine disorders	Systematic Assessment	EG0005 events4 affected210 at risk
Extracardiac Stimulation - Lv	Cardiac disorders	Systematic Assessment	EG0005 events5 affected210 at risk
Gastrointestinal	Gastrointestinal disorders	Systematic Assessment	EG00017 events14 affected210 at risk
Gastrointestinal - Heart Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Genitourinary	Renal and urinary disorders	Systematic Assessment	EG0007 events7 affected210 at risk
Cataract	Eye disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Heart Failure Symptoms - Unspecified	Cardiac disorders	Systematic Assessment	EG0006 events6 affected210 at risk
Hematological	Blood and lymphatic system disorders	Systematic Assessment	EG0005 events4 affected210 at risk
Hematoma - Pocket (<=30 Days Post-Implant)	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Hypotension	Cardiac disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Hypotension - Heart Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Impedance < 300 Ohms - Ra	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Inadvertent Vt/Vf	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Inappropriate Tachy Therapy - Svt	Cardiac disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Infection (> 3 Days Post-Implant)	Infections and infestations	Systematic Assessment	EG0001 events1 affected210 at risk
Integumentary	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Intracardiac Thrombus	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Migration	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Mitral Regurgitation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Multi-System Failure	Immune system disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Multi-System Failure - Heart Failure	Cardiac disorders	Systematic Assessment	EG0005 events5 affected210 at risk
Multiple Heart Failure Symptoms	Cardiac disorders	Systematic Assessment	EG00034 events25 affected210 at risk
Multiple Symptoms	Immune system disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0006 events4 affected210 at risk
Myocardial Infarction	Cardiac disorders	Systematic Assessment	EG0004 events4 affected210 at risk
Myocardial Perforation Post-Implant - Rv	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Myocardial Perforation With Tamponade	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Neurological	Nervous system disorders	Systematic Assessment	EG0005 events4 affected210 at risk
Other-Lead-Procedure	Cardiac disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Pericardial Effusion	Cardiac disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Peripheral Edema - Heart Failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Peripheral Vascular Disease	Vascular disorders	Systematic Assessment	EG0003 events3 affected210 at risk
Physical Trauma	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected210 at risk
Pleural Effusion	Cardiac disorders	Systematic Assessment	EG0002 events1 affected210 at risk
Pneumothorax - Procedure	Cardiac disorders	Systematic Assessment	EG0004 events4 affected210 at risk
Post-Surgical Wound Discomfort	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Premature Ventricular Contractions (Pvc)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Psychological	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00023 events14 affected210 at risk
Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Pulmonary Edema - Heart Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Renal	Renal and urinary disorders	Systematic Assessment	EG0008 events7 affected210 at risk
Renal Failure Due To Contrast Media - Procedure	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Renal Insufficiency - Heart Failure	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Sinus Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Syncope	Cardiac disorders	Systematic Assessment	EG0003 events3 affected210 at risk
Systemic Infection	Infections and infestations	Systematic Assessment	EG0005 events4 affected210 at risk
Unable To Capture - Lv	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Unable To Convert - Defibrillation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Ventricular Fibrillation (Vf)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Ventricular Flutter	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Ventricular Tachycardia (Vt)	Cardiac disorders	Systematic Assessment	EG0004 events3 affected210 at risk
Failure To Implant Epicardial Lv Lead	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Inability To Place The Lv Lead	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Left Chest Wall Emphysema	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Left Leg Ischemia	Vascular disorders	Systematic Assessment	EG0001 events1 affected210 at risk
ICD shocks	Cardiac disorders	Systematic Assessment	EG0002 events2 affected210 at risk
Severe Rt. Leg Stump Infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected210 at risk
Unable To Insert Lv Lead With Initial Procedure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected210 at risk
Vestibulitis	Ear and labyrinth disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Angioedema	General disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Patient Death - unknown cause	General disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Shortness of breath	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abnormal Laboratory Values	General disorders	Non-systematic Assessment	EG00010 events7 affected210 at risk
Allergic Reaction	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Delirium	General disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Hypotension	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected210 at risk
Atrial Fibrillation	Cardiac disorders	Non-systematic Assessment	EG00012 events11 affected210 at risk
Atrial Flutter	Cardiac disorders	Non-systematic Assessment	EG0003 events3 affected210 at risk
Atrial Tachyarrhythmias	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected210 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0003 events3 affected210 at risk
Unable to perform Threshold test-RV	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Chest Pain-Ischemic	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Chest Pain-Other	Cardiac disorders	Non-systematic Assessment	EG0005 events5 affected210 at risk
COPD	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected210 at risk
Coronary Venous Dissection	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected210 at risk
Dislodgment-extracardiac stimulation-RA	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Dislodgment-LV	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Dislodgment-unable to capture-LV	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Dislodgment-unable to capture-RV	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Dizziness	General disorders	Non-systematic Assessment	EG0004 events4 affected210 at risk
Dyspnea-heart failure	Cardiac disorders	Non-systematic Assessment	EG0003 events3 affected210 at risk
Endocrine	Endocrine disorders	Non-systematic Assessment	EG0005 events5 affected210 at risk
Extracardiac stimulation-LV	Cardiac disorders	Non-systematic Assessment	EG00030 events28 affected210 at risk
Fatigue	General disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Gastrointestinal	Gastrointestinal disorders	Non-systematic Assessment	EG00010 events8 affected210 at risk
Genitorurinary	Renal and urinary disorders	Non-systematic Assessment	EG00011 events10 affected210 at risk
Visual disturbances	Eye disorders	Non-systematic Assessment	EG0003 events2 affected210 at risk
Hematological	Blood and lymphatic system disorders	Non-systematic Assessment	EG0006 events6 affected210 at risk
Hematoma (less than 30 days post implant)	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0007 events7 affected210 at risk
Hypertension	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Hypotension	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Immune disorder	Immune system disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Insulation breach-RV	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Integumentary	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0008 events8 affected210 at risk
Mitral regurgitation	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Multiple Heart Failure Symptoms	Cardiac disorders	Non-systematic Assessment	EG0007 events5 affected210 at risk
Muskuloskeletal	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00016 events14 affected210 at risk
Myocardial Infarction	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Neurological	Nervous system disorders	Non-systematic Assessment	EG0004 events3 affected210 at risk
Nonsustained Ventricular Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected210 at risk
Other PG-system-procedure	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Cardiovascular event	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Oversensing-RV	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Pacemaker Mediated Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0008 events8 affected210 at risk
Palpitations	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Peripheral edema-heart failure	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected210 at risk
Peripheral vascular disease	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
PG system-event	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Physical Trauma	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00012 events11 affected210 at risk
Post surgical infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected210 at risk
Post-surgical Pocket Hemorhage	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Post-surgical wound discomfort	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0009 events9 affected210 at risk
Premature ventricular contractions	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Psychological	Psychiatric disorders	Non-systematic Assessment	EG0003 events2 affected210 at risk
Psychological effect due to device therapy	Psychiatric disorders	Non-systematic Assessment	EG0002 events2 affected210 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00014 events14 affected210 at risk
Renal	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Sinus Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Syncope	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Thromboembolic events	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Transient Ischemic Attack	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Unable to capture-LV lead	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected210 at risk
Undersensing-RA	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Venous Occlusion	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Ventricular Tacchyarrhythmias	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Weight Gain	General disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Adverse Drug Reaction	General disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Cocaine Abuse	General disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Ear reaction	Ear and labyrinth disorders	Non-systematic Assessment	EG0002 events1 affected210 at risk
Cerumen impaction	Ear and labyrinth disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Swollen neck	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
ICD shocks	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Low LVEF	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
High LV lead impedance	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
High RV lead impedance	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk
Low pacing output	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected210 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Units	Counts
Participants	OG000183
RVAT ambulatory threshold paired dataset	OG000314

Units	Counts
Participants	OG000175
LVAT ambulatory threshold paired dataset	OG000300