Strategic Management to Optimize Response To Cardiac Resy... | NCT03089281

NCT03089281

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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
SmartDelay™ algorithm	Other	Subjects programmed with AV Delay and pacing chamber determined by SmartDelay	Device: CRT-D
Fixed AV Delay with BiV pacing	Other	Subjects programmed with a Fixed AV Delay of 120ms with BiV pacing	Device: CRT-D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CRT-D	Device	Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing. All enrolled subjects with implanted BSC X4 CRT-D system and identified with an RV-LV delay of ≥70ms were 1:1 randomized. Randomization occurred in the electronic data capturing system.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CRT Response	Comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. A negative change in LVESV is considered an improvement; CRT response is defined by a change in Left Ventricular End Systolic Volume (LVESV) < -15% at 6 months compared to pre-implant baseline.	Pre-Implant baseline to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in Left Ventricular End Systolic Volume (Absolute Change)	Comparing absolute changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in milliliters. A negative change in LVESV is considered an improvement.	Implant to 6 Months

Other Outcomes

Measure	Description	Time Frame
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Social Limitation Score	The KCCQ Social Limitation Domain quantifies the extent to which heart failure symptoms impair patients' ability to interact in a number of gender-neutral social activities. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.	Implant to 6 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.
In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:
- Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
- Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
Subject is willing and capable of providing informed consent
Subject is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria:

Subjects with documented permanent complete AV block
Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
Women of childbearing potential who are or plan to become pregnant during the course of the trial
Subjects currently requiring dialysis

Contacts/Locations Module

Name	Affiliation	Role
Michael R. Gold, MD	Medical University of South Carolina	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Affinity Hospital, LLC d/b/a Granview Medical Center		Birmingham	Alabama	35243	United States
Heart Center Research LLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37183700	Derived	Gold MR, Ellenbogen KA, Leclercq C, Lowy J, Rials SJ, Shoda M, Tomassoni G, Issa Z, Sarrazin JF, Jennings JM, Nair DG, Wold N, Yong P, Harbin MM, Stein KM, Auricchio A. Effects of Atrioventricular Optimization on Left Ventricular Reverse Remodeling With Cardiac Resynchronization Therapy: Results of the SMART-CRT Trial. Circ Arrhythm Electrophysiol. 2023 Jun;16(6):e011714. doi: 10.1161/CIRCEP.122.011714. Epub 2023 May 15.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
FG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 10, 2017

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
BG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed
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
	OG000116 OG001105

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		Chi-squared		0.17														Superiority

Secondary

Change in Left Ventricular End Systolic Volume (Absolute Change)

Comparing absolute changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in milliliters. A negative change in LVESV is considered an improvement.

A total of 130 randomized subjects did not contribute data to the secondary endpoint analysis due to death or withdrawal prior to six months, missed six-month visit or incomplete/insufficient echocardiogram.

Posted

Mean

Standard Deviation

milliliters

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Units	Counts
Participants	OG000

Secondary

Change in Left Ventricular End Systolic Volume (Relative Change)

Comparing relative changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 100*(6-Month measurement - Implant measurement)/(Implant Measurement), in %. A negative change in LVESV is considered an improvement.

Posted

Mean

Standard Deviation

% change

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Units	Counts
Participants	OG000

Secondary

Change in Left Ventricular Ejection Fraction (Absolute Change)

Comparing absolute changes in Left Ventricular Ejection Fraction from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in % of blood ejected during LV contraction. A positive change in LVEF is considered an improvement.

A total of 129 randomized subjects did not contribute data to the secondary endpoint analysis due to death or withdrawal prior to six months, missed six-month visit or incomplete/insufficient echocardiogram.

Posted

Mean

Standard Deviation

% of blood ejected during LV contraction

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Units	Counts
Participants

Secondary

Change in Left Ventricular Ejection Fraction (Relative Change)

Comparing relative changes in Left Ventricular Ejection Fraction from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 100*(6-Month measurement - Implant measurement)/(Implant Measurement), in %. A positive change in LVEF is considered an improvement.

Posted

Mean

Standard Deviation

% change

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Units	Counts
Participants	OG000

Secondary

Clinical Composite Score (CCS)

Th CCS combines four metrics: all-cause mortality, heart failure hospitalization (HFH), New York Heart Association (NYHA) Class, and quality of life as measured with the patient global assessment (GA) instrument.

The CCS categorizes each subject into one of three groups: Improved, Unchanged or Worsened.

Improved: Subjects that survived without a HFH through the 6-month visit window and had either an improvement in NYHA class or responded to GA with "much better" or "very much better".
Unchanged: All patients that reached the end of 6-month visit window that were not categorized as either "Improved" or "Worsened".
Worsened: Subjects that died or had HFH within 6-month visit window or had either a worsening in NYHA class or responded to GA with "much worse" or "very much worse".

Subjects that were followed through the end of the 6-month visit window and those that died and/or or had a heart failure hospitalization within the 6-month visit window contributed to this endpoint. A total of 34 subjects did not meet these conditions are were therefore excluded from endpoint analysis.

Posted

Count of Participants

Participants

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Secondary

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

The KCCQ is a disease-specific instrument for monitoring the health status and quality of life of subjects with congestive heart failure. It includes a total of 23 items that assess quality of life in the following domains: physical function, symptom frequency and severity, symptom stability, self-efficacy and knowledge, social function, and overall quality of life. These domains can be combined into a functional status summary score (derived from the physical function and symptom scales) and an overall summary score which combines the physical function, symptom, social function and quality of life domains.

KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.

Subjects that completed the KCCQ at both the implant and 6 month visits contributed to this endpoint. A total of 51 subjects did not contribute data to the endpoint.

Posted

Mean

Standard Deviation

score on a scale

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Other Pre-specified

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Social Limitation Score

The KCCQ Social Limitation Domain quantifies the extent to which heart failure symptoms impair patients' ability to interact in a number of gender-neutral social activities.

KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.

Subjects that completed the KCCQ at both the implant and 6 month visits contributed to this endpoint. A total of 51 subjects did not contribute data to the endpoint.

Posted

Mean

Standard Deviation

score on a scale

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Units	Counts
Participants	OG000

Other Pre-specified

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score

KCCQ Quality of Life Domain is designed to reflect patients' assessment of their quality of life, given the current status of their heart failure.

KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.

Subjects that completed the KCCQ at both the implant and 6 month visits contributed to this endpoint. A total of 51 subjects did not contribute data to the endpoint.

Posted

Mean

Standard Deviation

score on a scale

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Units	Counts
Participants	OG000

Other Pre-specified

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Self-Efficacy Score

KCCQ Self-efficacy Domain quantifies patients' perceptions of how to prevent heart failure exacerbations and manage complications when they arise. This scale is not included in the summary scores.

KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.

Subjects that completed the KCCQ at both the implant and 6 month visits contributed to this endpoint. A total of 51 subjects did not contribute data to the endpoint.

Posted

Mean

Standard Deviation

score on a scale

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Units	Counts
Participants	OG000

Other Pre-specified

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Frequency Score

KCCQ Symptom Domain quantifies the frequency of clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling.

KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.

Subjects that completed the KCCQ at both the implant and 6 month visits contributed to this endpoint. A total of 51 subjects did not contribute data to the endpoint.

Posted

Mean

Standard Deviation

score on a scale

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Units	Counts
Participants	OG000

Other Pre-specified

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Burden Score

KCCQ Symptom Domain quantifies the burden of clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling.

KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.

Subjects that completed the KCCQ at both the implant and 6 month visits contributed to this endpoint. A total of 51 subjects did not contribute data to the endpoint.

Posted

Mean

Standard Deviation

score on a scale

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Units	Counts
Participants	OG000

Other Pre-specified

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation Score

KCCQ Physical Function Domain measures the limitations patients experience, due to their heart failure symptoms, in performing routine activities. Activities are common, gender-neutral, and generalizable across cultures, while also capturing a range of exertional requirements.

KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.

Subjects that completed the KCCQ at both the implant and 6 month visits contributed to this endpoint. A total of 51 subjects did not contribute data to the endpoint.

Posted

Mean

Standard Deviation

score on a scale

Implant to 6 Months

ID	Title	Description
OG000	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm
OG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed

Units	Counts
Participants

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	SmartDelay™ Algorithm	AV Delay and pacing chamber were determined by SmartDelay algorithm	7	225	49	225	20	225
EG001	Fixed AV Delay With BiV Pacing	Fixed AV Delay of 120ms with BiV pacing was programmed	0	215	46	215	22	215

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Infection > 30 Days Post-Implant (Pulse Generator-related)	Product Issues	Non-systematic Assessment	EG0002 affected225 at risk EG0010 affected215 at risk
Unable to Capture (Right Atrial Lead-related)	Product Issues	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Dislodgment (Right Atrial Lead-Related)	Product Issues	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Dislodgment (Right Ventricular Lead-Related)	Product Issues	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Dislodgment (Left Ventricular Lead-Related)	Product Issues	Non-systematic Assessment	EG0005 events5 affected225 at risk EG0014 events4 affected215 at risk
Post-Surgical Wound Discomfort/Bruising/Swelling	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Post-Surgical Infection (<=30 Days Post-Implant)	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0012 events2 affected215 at risk
Adverse Reaction - General	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Hematoma - Pocket (<=30 Days Post-Implant)	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0003 events3 affected225 at risk EG0010 events0 affected215 at risk
Thromboembolic Events	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Pneumothorax	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0011 events1 affected215 at risk
Venous Occlusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Heart Failure	Cardiac disorders	Non-systematic Assessment	EG00017 events14 affected225 at risk EG00124 events16 affected215 at risk
Ventricular Fibrillation	Cardiac disorders	Non-systematic Assessment	EG0003 events3 affected225 at risk EG0012 events2 affected215 at risk
Ventricular Tachycardia/Monomorphic VT	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0012 events2 affected215 at risk
Atrial Fibrillation	Cardiac disorders	Non-systematic Assessment	EG0003 events2 affected225 at risk EG0011 events1 affected215 at risk
Premature Ventricular Contractions (PVC)	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Hypotension/Orthostatic Hypotension	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Cardiogenic Shock	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected225 at risk EG0010 events0 affected215 at risk
Myocardial Infarction	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0011 events1 affected215 at risk
Coronary Artery Disease	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Peripheral Vascular Disease	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0012 events2 affected215 at risk
Mitral Stenosis	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Valvular Damage/Valvular Insufficiency	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Syncope	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Dizziness	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Chest Pain - Ischemic	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Dyspnea	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Cerebrovascular Accident (CVA)	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Pulmonary Embolism	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0012 events2 affected215 at risk
Intracardiac Thrombus	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Pericarditis	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Atrial Septal Defect	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Adverse Reaction - General	General disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Adverse reaction - Allergic Reaction	Immune system disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Adverse reaction - Medication	General disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Death	General disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Systemic Infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0013 events3 affected215 at risk
Fever/Virus	General disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Physical Trauma	General disorders	Non-systematic Assessment	EG0003 events3 affected225 at risk EG0015 events3 affected215 at risk
Abnormal Laboratory Values	General disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0012 events1 affected215 at risk
Neurological	General disorders	Non-systematic Assessment	EG0002 events2 affected225 at risk EG0012 events2 affected215 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected225 at risk EG0012 events2 affected215 at risk
Genitourinary	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0011 events1 affected215 at risk
Gastrointestinal	Gastrointestinal disorders	Non-systematic Assessment	EG0006 events6 affected225 at risk EG0014 events4 affected215 at risk
Renal	Renal and urinary disorders	Non-systematic Assessment	EG0006 events4 affected225 at risk EG0013 events2 affected215 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0013 events2 affected215 at risk
Psychological	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 affected215 at risk
Integumentary	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0011 events1 affected215 at risk
Endocrine	Endocrine disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Immune	Immune system disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Cancer	General disorders	Non-systematic Assessment	EG0003 events3 affected225 at risk EG0012 events2 affected215 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Oversensing (Pulse Generator-related)	Product Issues	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Inappropriate Tachy Therapy (Pulse Generator-Related)	Product Issues	Non-systematic Assessment	EG0002 events2 affected225 at risk EG0011 events1 affected215 at risk
Fatigue (Pulse Generator-Related)	Product Issues	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Dislodgment (Right Atrial Lead-Related)	Product Issues	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0011 events1 affected215 at risk
Dislodgment (Right Ventricular Lead-Related)	Product Issues	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Extracardiac Stimulation (Right Ventricular Lead-Related)	Product Issues	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Inappropriate Tachy Therapy (Right Ventricular Lead-Related)	Product Issues	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Unable to Capture (Left Ventricular Lead-Related)	Product Issues	Non-systematic Assessment	EG0002 events2 affected225 at risk EG0012 events2 affected215 at risk
Extracardiac Stimulation (Left Ventricular Lead-Related)	Product Issues	Non-systematic Assessment	EG0004 events4 affected225 at risk EG0017 events7 affected215 at risk
Perforation at Implant (Left Ventricular Lead-Related)	Product Issues	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Dislodgment (Left Ventricular Lead-Related)	Product Issues	Non-systematic Assessment	EG0002 events2 affected225 at risk EG0013 events3 affected215 at risk
Hematoma - Pocket (<=30 days post-implant)	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0011 events1 affected215 at risk
Pneumothorax	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Lower Extremity Edema	Surgical and medical procedures	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Heart Failure	Cardiac disorders	Non-systematic Assessment	EG0007 events3 affected225 at risk EG0012 events2 affected215 at risk
Ventricular Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Atrial Flutter	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk
Atrial Tachycardia / Other Supraventricular Tachycardia (SVT)	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Chest Pain	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected215 at risk
Fatigue / Weakness	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected215 at risk

First MCP Posted Date

ID	Term
D006333	Heart Failure

ParticipantsBG002440

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases