ENABLE MRI (Magnetic Resonance Imaging) | NCT02652481

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ImageReady MR Conditional Defibrillation System Group	Other	Prospective, non-randomized, confirmatory study.Subjects will initially be enrolled into Phase I to undergo a non-diagnostic study required MR Scan. Once Phase I is complete, subjects will be enrolled into Phase II where there is no requirement to undergo a non-diagnostic study required MR scan Up to 37 subjects will be used for an interim analysis. Of these subjects, the first 20 who undergo the study required MRI scan and complete the MRI + 1 Month Visit will be used for this analysis. The second cohort will consist of subjects who will receive the non-diagnostic study required MR scan until 137 CRT-D and 28 VR ( single chamber) ICD subjects undergo the study required MR scan (complete or incomplete). De novo implants and existing implants may be enrolled in Phase I There will be a non-diagnostic study required MR scan (during the MRI visit) There will be a study required MRI visit and MRI + 1 month visit	Device: ImageReady MR Conditional Defibrillation System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ImageReady MR Conditional Defibrillation System	Device	ImageReady MR Conditional Defibrillation System Components: Device Name Device Model Number Pulse Generators Phase I and II Phase II Only * CRT-D (IS1/DF4/IS4) VR ICD (DF4) DR ( dual chamber) ICD (IS1/DF4) ORIGEN™ MINI ICD ORIGEN EL ICD ORIGEN X4 CRT INOGEN™ MINI ICD INOGEN EL ICD INOGEN X4 CRT DYNAGEN™ MINI ICD DYNAGEN EL ICD DYNAGEN X4 CRT-D AUTOGEN ™ MINI ICD* AUTOGEN EL ICD* AUTOGEN X4 CRT-D* Right Atrial Leads and Accessories FINELINE™ II Sterox FINELINE II Sterox EZ Suture Sleeves for FINELINE II Leads INGEVITY™ MRI* Suture Sleeve for INGEVITY MRI* IS-1 Lead Port Plug 7145 Right Ventricular Leads and Accessories RELIANCE 4-FRONT™ (DF4)* Suture Sleeve for RELIANCE 4-FRONT leads; ENDOTAK RELIANCE™ (DF4) Left Ventricular Leads and Accessories ACUITY™ X4 (IS4) Suture Sleeve for ACUITY X4 leads May only be used internationally outside the US

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications	MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit	The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV	Increases in RV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in average pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up were considered a success.	The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms.	Increases in average LV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in pacing thresholds measurements ≤ 1.0V (at 0.5 ms) from pre-MR Scan at MRI Visit to MRI + 1 Month Visit were considered a success.	The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude	Decreases in RV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value. Subjects who had an average pre-scan RV sensed amplitude measurement < 5.0 mV were excluded from this analysis.	The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude	Decreases in average LV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remained ≥ 5.0 mV and above 50% of the average pre-MR scan value. Subjects who had an average pre-scan LV sensed amplitude measurement < 5.0 mV were excluded from this analysis.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Phase I: Subject is indicated per guidelines and will receive a CRT-D or ICD system OR Subject is implanted with a functional and stable CRT-D or ICD system Phase II: Subject is implanted with a functional and stable CRT-D or ICD system
Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region
Subject is able and willing to undergo an MR scan without intravenous sedation (Phase I only)
Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Key Exclusion Criteria:

Subject implanted with an ICD or CRT-D pulse generator with battery at Explant status
Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders
Presence of metallic objects that represent a contraindication to MR imaging at the discretion of the Radiologist and impacting the ability to conduct the study protocol
Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit (Phase I only)
Subject with:
- A history of syncope related to brady-arrhythmia
- A history of syncope of unknown etiology
- Sinus pauses (Pause > 2 s)
- Permanent or intermittent complete AV (Atrioventricular ) block
- Documentation of progressive AV nodal block over time
- Trifascicular block (alternating bundle branch block or PR > 200 ms (interval between P wave and R-wave) with LBBB ( Left bundle branch block) or other bifascicular block) Note: It is required to run a 12 lead ECG (Electrocardiography) and a 10s rhythm strip to document this exclusion criterion. During ECG acquisition, subjects must be in either their own intrinsic rhythm or, in subjects with an existing device implant, the device must be programmed to VVI (ventricular demand pacing) 40 ppm.
Subject is not clinically capable of tolerating the absence of pacing or Resynchronization therapy support in a supine position for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion
Subject is not clinically capable of tolerating the absence of Tachycardia therapy support for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion
Subjects with a planned RA( right atrium), RV ( right ventricle) or LV (left ventricle) lead revision or extraction within 30 days of enrollment (Phase I only)
Subjects with an implanted lead that is planned to be extracted during the study implant procedure
Subjects currently requiring dialysis
Subject has a mechanical heart valve
Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
Subject is currently on the active heart transplant list
Subject has documented life expectancy of less than 12 months
Subject is enrolled in a concurrent 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 might be pregnant, and will receive an ICD or CRT-D pulse generator

VF Induction Sub-study Exclusion Criteria:

In addition to meeting all of the inclusion criteria and none of the exclusion criteria of the ENABLE MRI study, subjects enrolled in the VF Induction Sub-study must also not meet any of the following VF Induction Sub-study exclusion criteria:

Unstable heart failure requiring hospitalization in the last 30 calendar days
Unable to tolerate sedation (e.g. IV (intravenous sedation )sedation, general anesthesia)
Planned cardiac revascularization procedure
Right Ventricular Lead R wave is less than 5 mV(milliVolt)

Name	Affiliation	Role
Gregory Voss	Boston Scientific Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Heart Center Research, LLC		Huntsville	Alabama		United States
Cardiology Associates of Northeast Arkansas

PubMed Identifier	Type	Citation	Retractions
32911050	Derived	Rinaldi CA, Vitoff PJ, Nair DG, Bernstein R, Mountantonakis SE, Rapacciuolo A, Carter N, Tse HF, Green UB. Safety of magnetic resonance imaging scanning in patients with cardiac resynchronization therapy-defibrillators incorporating quadripolar left ventricular leads. Heart Rhythm. 2020 Dec;17(12):2064-2071. doi: 10.1016/j.hrthm.2020.08.020. Epub 2020 Sep 7.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ImageReady MR Conditional Defibrillation System Group	This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 11, 2016

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

Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications

MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit

All implanted subjects that completed any portion of the study required MR scan and did not have a Medically Necessary Scan (MNS) performed prior to the MRI+1 Month Visit were included in the Primary Safety Endpoint analysis set.

Posted

Number

97.5% Confidence Interval

percentage of participants

The time between the MR Scan and MRI + 1 Month

ID	Title	Description
OG000	ImageReady MR Conditional Defibrillation System Group	This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system

Units	Counts
Participants	OG000159

Title

Denominators

Categories

Title	Measurements
	OG000100(100 to 100)

Primary

Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV

Increases in RV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in average pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up were considered a success.

Did not include subjects that had a MNS between implant and the MRI+1Month Visit; Failed to meet Conditions of Use; Experienced lead-related complication; Had an incomplete scan or no scan, died or withdrew consent, missed a visit, missed lead measurements

Posted

Number

95% Confidence Interval

percentage of participants with success

The time between the MR Scan and MRI + 1 Month

ID	Title	Description
OG000	ImageReady MR Conditional Defibrillation System Group	This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system

Primary

Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms.

Increases in average LV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in pacing thresholds measurements ≤ 1.0V (at 0.5 ms) from pre-MR Scan at MRI Visit to MRI + 1 Month Visit were considered a success.

did not include subjects with a MNS between implant and the MRI + 1 Month Visit;failed to meet labeled MRI Conditions of Use, had lead-related complication;had an incomplete scan or no scan; missing lead measurements; missed a visits, subject died or withdrew consent

Posted

Number

95% Confidence Interval

percentage of participants with succes

The time between the MR Scan and MRI + 1 Month

ID	Title	Description
OG000	ImageReady MR Conditional Defibrillation System Group	This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system

Primary

Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude

Decreases in RV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value. Subjects who had an average pre-scan RV sensed amplitude measurement < 5.0 mV were excluded from this analysis.

Posted

Number

95% Confidence Interval

percentage of participants with succes

The time between the MR Scan and MRI + 1 Month

ID	Title	Description
OG000	ImageReady MR Conditional Defibrillation System Group	This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system

Primary

Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude

Decreases in average LV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remained ≥ 5.0 mV and above 50% of the average pre-MR scan value. Subjects who had an average pre-scan LV sensed amplitude measurement < 5.0 mV were excluded from this analysis.

Posted

Number

95% Confidence Interval

percentage of participants with succes

The time between the MR Scan and MRI + 1 Month

ID	Title	Description
OG000	ImageReady MR Conditional Defibrillation System Group	This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Unable to capture - LV PG System	Product Issues	Systematic Assessment	EG0000 events0 affected495 at risk
Extracardiac stimulation - LV PG System	Product Issues	Systematic Assessment	EG0000 events0 affected495 at risk
Inappropriate Tachy Therapy - SVT - PG System Therapy	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Pacemaker Mediated Tachycardia - PG System Therapy	Product Issues	Systematic Assessment	EG0000 events0 affected495 at risk
Infection (>30 days post-implant) - PG System - Subject related	Infections and infestations	Systematic Assessment	EG0006 events6 affected495 at risk
Dislodgment - Elevated threshold -RV Lead	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Dislodgment - Multiple signs - RV Lead	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Dislodgment - No reported signs - RV Lead	Product Issues	Systematic Assessment	EG0002 events2 affected495 at risk
Dislodgment - No reported signs - LV Lead	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Post-surgical wound discomfort/bruising/swelling	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected495 at risk
Adverse reaction - Respiratory - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected495 at risk
Hematoma - Pocket (<=30 days post-implant)	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected495 at risk
Pneumothorax - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected495 at risk
Pericardial effusion - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected495 at risk
Venous occlusion - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected495 at risk
Other - PG system procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected495 at risk
Dyspnea - Heart failure	Cardiac disorders	Systematic Assessment	EG0009 events8 affected495 at risk
Peripheral edema - Heart failure	Cardiac disorders	Systematic Assessment	EG0004 events4 affected495 at risk
Hypotension - Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Heart failure symptoms - Unspecified	Cardiac disorders	Systematic Assessment	EG00011 events11 affected495 at risk
Multiple heart failure symptoms	Cardiac disorders	Systematic Assessment	EG00037 events28 affected495 at risk
Ventricular Fibrillation (VF)	Cardiac disorders	Systematic Assessment	EG0005 events4 affected495 at risk
Ventricular Tachycardia (VT)/Monomorphic VT	Cardiac disorders	Systematic Assessment	EG0006 events5 affected495 at risk
Nonsustained Ventricular Tachycardia (NSVT)	Cardiac disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Atrial Fibrillation (AF)	Cardiac disorders	Systematic Assessment	EG0006 events5 affected495 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Atrial (Type I) Flutter	Cardiac disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Hypotension/Orthostatic Hypotension	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Hypertension/Hypertensive Crisis	Cardiac disorders	Systematic Assessment	EG0002 events1 affected495 at risk
Cardiogenic shock	Cardiac disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0003 events3 affected495 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0004 events4 affected495 at risk
Coronary Artery Disease	Cardiac disorders	Systematic Assessment	EG0005 events5 affected495 at risk
Peripheral vascular disease	Cardiac disorders	Systematic Assessment	EG0006 events6 affected495 at risk
Syncope	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Dizziness	Cardiac disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Chest pain - Ischemic	Cardiac disorders	Systematic Assessment	EG0004 events4 affected495 at risk
Chest pain - Other	Cardiac disorders	Systematic Assessment	EG0004 events4 affected495 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Adverse reaction - Hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Adverse reaction - Anesthesia	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected495 at risk
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00015 events8 affected495 at risk
Adverse reaction - Medication	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected495 at risk
Systemic infection	Blood and lymphatic system disorders	Systematic Assessment	EG00011 events10 affected495 at risk
Physical trauma	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Abnormal laboratory values	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Localized Infection	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Neurological	Nervous system disorders	Systematic Assessment	EG0003 events3 affected495 at risk
Gastrointestinal	Gastrointestinal disorders	Systematic Assessment	EG00020 events13 affected495 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00019 events17 affected495 at risk
Genitourinary	Reproductive system and breast disorders	Systematic Assessment	EG0006 events5 affected495 at risk
Renal	Renal and urinary disorders	Systematic Assessment	EG0008 events7 affected495 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00011 events9 affected495 at risk
Psychological	Psychiatric disorders	Systematic Assessment	EG0002 events1 affected495 at risk
Endocrine	Endocrine disorders	Systematic Assessment	EG00012 events10 affected495 at risk
Cancer	General disorders	Systematic Assessment	EG0009 events7 affected495 at risk
Multi-system failure	General disorders	Systematic Assessment	EG0003 events3 affected495 at risk
Unable to capture - RV Lead	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Conductor coil fracture - RA Lead	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Migration - PG System - Subject related	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Myocardial perforation with tamponade	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Chest pain - Heart failure	Cardiac disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Pulmonary edema - Heart failure	Cardiac disorders	Systematic Assessment	EG0003 events3 affected495 at risk
Renal insufficiency/failure - Heart failure	Cardiac disorders	Systematic Assessment	EG0003 events3 affected495 at risk
Dehydration - Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Gastrointestinal - Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Aortic stenosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Mitral regurgitation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Valvular damage/Valvular insufficiency	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Transient Ischemic Attack (TIA)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Cerebrovascular Accident (CVA)	Cardiac disorders	Systematic Assessment	EG0004 events4 affected495 at risk
Intracardiac thrombus	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Incessant VT/VT Storm	Cardiac disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Fever and/or Virus	Infections and infestations	Systematic Assessment	EG0002 events2 affected495 at risk
Hematological	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected495 at risk
Integumentary	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0004 events3 affected495 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Unable to capture - LV PG System	Product Issues	Systematic Assessment	EG0002 events2 affected495 at risk
Extracardiac stimulation - LV PG System	Product Issues	Systematic Assessment	EG00020 events20 affected495 at risk
Inappropriate Tachy Therapy - SVT - PG System Therapy	Product Issues	Systematic Assessment	EG0006 events6 affected495 at risk
Pacemaker Mediated Tachycardia - PG System Therapy	Product Issues	Systematic Assessment	EG0004 events4 affected495 at risk
Infection (>30 days post-implant) - PG System - Subject related	Infections and infestations	Systematic Assessment	EG0002 events2 affected495 at risk
Dislodgment - Elevated threshold -RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected495 at risk
Dislodgment - Multiple signs - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected495 at risk
Dislodgment - No reported signs - RV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected495 at risk
Dislodgment - No reported signs - LV Lead	Product Issues	Systematic Assessment	EG0000 events0 affected495 at risk
Post-surgical wound discomfort/bruising/swelling	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected495 at risk
Adverse reaction - Respiratory - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected495 at risk
Hematoma - Pocket (<=30 days post-implant)	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 events4 affected495 at risk
Pneumothorax - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected495 at risk
Pericardial effusion - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected495 at risk
Venous occlusion - Procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected495 at risk
Other - PG system procedure	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected495 at risk
Dyspnea - Heart failure	Cardiac disorders	Systematic Assessment	EG0004 events4 affected495 at risk
Peripheral edema - Heart failure	Cardiac disorders	Systematic Assessment	EG0004 events4 affected495 at risk
Hypotension - Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Heart failure symptoms - Unspecified	Cardiac disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Multiple heart failure symptoms	Cardiac disorders	Systematic Assessment	EG00014 events14 affected495 at risk
Ventricular Fibrillation (VF)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Ventricular Tachycardia (VT)/Monomorphic VT	Cardiac disorders	Systematic Assessment	EG0006 events5 affected495 at risk
Nonsustained Ventricular Tachycardia (NSVT)	Cardiac disorders	Systematic Assessment	EG0004 events4 affected495 at risk
Atrial Fibrillation (AF)	Cardiac disorders	Systematic Assessment	EG00012 events11 affected495 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0003 events3 affected495 at risk
Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Atrial (Type I) Flutter	Cardiac disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Hypotension/Orthostatic Hypotension	Cardiac disorders	Systematic Assessment	EG0004 events4 affected495 at risk
Hypertension/Hypertensive Crisis	Cardiac disorders	Systematic Assessment	EG0006 events6 affected495 at risk
Cardiogenic shock	Cardiac disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Coronary Artery Disease	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Peripheral vascular disease	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Syncope	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Dizziness	Cardiac disorders	Systematic Assessment	EG0003 events3 affected495 at risk
Chest pain - Ischemic	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Chest pain - Other	Cardiac disorders	Systematic Assessment	EG0007 events7 affected495 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Adverse reaction - Hypotension	Vascular disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Adverse reaction - Anesthesia	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected495 at risk
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Adverse reaction - Medication	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected495 at risk
Systemic infection	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Physical trauma	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Abnormal laboratory values	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Localized Infection	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Neurological	Nervous system disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Gastrointestinal	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected495 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected495 at risk
Genitourinary	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Renal	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Psychological	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Endocrine	Endocrine disorders	Systematic Assessment	EG0002 events2 affected495 at risk
Cancer	General disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Multi-system failure	General disorders	Systematic Assessment	EG0000 events0 affected495 at risk
Elevated threshold - LV PG System	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Psychological effect due to device therapy - PG System - Subject related	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected495 at risk
pain at device site	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Conductor coil fracture - RA Lead	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Extracardiac stimulation - RV Lead	Product Issues	Systematic Assessment	EG0001 events1 affected495 at risk
Syncope - Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Hypertension - Heart failure	Cardiac disorders	Systematic Assessment	EG0003 events2 affected495 at risk
Premature Ventricular Contractions (PVC)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Distal thromboemboli	Vascular disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Pericardial effusion - Unrelated (non study) procedure or device	Cardiac disorders	Systematic Assessment	EG0001 events1 affected495 at risk
Hematological	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected495 at risk
HEENT	Infections and infestations	Systematic Assessment	EG0001 events1 affected495 at risk