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The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment: ICD/CRTD-indicated |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SJ4 connector and RV high voltage SJ4 lead | Device | Standard of care implantation of SJ4 device system |
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| Measure | Description | Time Frame |
|---|---|---|
| Right Ventricle (RV) Bipolar Capture Thresholds | 5 years | |
| Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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ICD and CRTD indicated patients
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Wilkoff, MD | The Clevleland Clinic Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SJ4 System Implanted | SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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Participants had an approved indication, as per ACC/AHA/HRS guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s) and will be implanted with a St. Jude Medical SJ4 system and had given informed consent prior to enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | SJ4 System Implanted | SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| New York Heart Association (NYHA) Class | NHYA classification:Class I-no limitation of physical activity, ordinary physical activity doesn't cause undue breathlessness, fatigue, or palpitations, Class II-slight limitation of physical activity;comfortable at rest; ordinary physical activity results in fatigue, palpitation, dyspnea, Class III-marked limitation of physical activity;comfortable at rest;less than ordinary activity causes fatigue, palpitation, or dyspnea, class IV-Unable to carry on any physical activity without discomfort; symptoms at rest can be present; if any physical activity is undertaken, discomfort is increased. | Number | participants |
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| Left Ventricular (LV) Ejection Fraction (%) | Mean | Standard Deviation | Percentage |
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| Primary Indication for Device Implant | Number | participants |
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| 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 | Right Ventricle (RV) Bipolar Capture Thresholds | Study participants with RV bipolar capture threshold at the 5 year follow up visit. | Posted | Mean | 90% Confidence Interval | Volts | 5 years |
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| Primary | Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector | Posted | Number | 90% Confidence Interval | percentage of patients | 5 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SJ4 System Implanted | SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s). | 0 | 1,701 | 376 | 1,701 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RV Lead or DF4 Connector Related Complication | General disorders | RV lead or DF4 connector related complications (an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention) |
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| System and/or Procedure Related Complication | General disorders | Various complications (an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention) reported that did not meet the <1% report threshold. |
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| Infection Complication | Infections and infestations | Infection complications (an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention) reported. |
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| LV Lead Dislodgment or Migration Complication | General disorders | LV Lead dislodgement and migration complication (an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention). |
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| RA Lead Dislodgement or Migration Complication | General disorders | RA lead dislodgement complication (an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention). |
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| Lead Dislodgement or Migration <30 days after Implant Complication | Surgical and medical procedures | All were resolved with lead repositioning or replacement. |
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| System and/or Procedure Related Observation | General disorders | Observations (an adverse event caused by or associated with the study device, system component(s), and or procedure that does not require invasive intervention) that did not meet the <1% reporting threshold. |
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| RV Lead or DF4 Connector Related Observation | General disorders | Summary of RV Lead or DF4 Connector Related Observations (an adverse event caused by or associated with the study device, system component(s), and or procedure that does not require invasive intervention). |
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| Elevated LV Pacing Thresholds Observation | General disorders | Elevated LV pacing threshold observations ((an adverse event caused by or associated with the study device, system component(s), and or procedure that does not require invasive intervention). |
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| Inappropriate Shock(s) Observation | General disorders | Therapy delivered for non-ventricular arrhythmias falling within the VT zones programmed in the device reported observations. |
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| LV Phrenic Nerve/ Diaphragmatic Stimulation Observation | General disorders | LV Phrenic nerve/ diaphragmatic stimulation observation(an adverse event caused by or associated with the study device, system component(s), and or procedure that does not require invasive intervention). |
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| RA Oversensing Observation | General disorders | RA over sensing observations (an adverse event caused by or associated with the study device, system component(s), and or procedure that does not require invasive intervention). |
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| Bleeding/ Hematoma Observation | Surgical and medical procedures | Oozing/bleeding at site of incision following implant/system revision of implanted device system observation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grant Kim, Director Clinical Studies | Saint Jude Medical | 818-493-3147 | gkim@sjm.com |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D016757 | Death, Sudden, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
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| Black or African American |
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| Hispanic or Latino |
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| Iranian |
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| Middle Eastern |
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| Native Hawaiian or Pacific Islander |
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| Other- Non Hispanic |
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| Persian |
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| White |
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| Hispanic/ Black (Puerto Rican) |
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| Title | Measurements |
|---|
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| Class 3 |
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| Class 4 |
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| Not Available |
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| Familial Condition |
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| HF With Wide QRS |
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| HF Without QRS |
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| HF Without Sinus Rhythm |
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| ICD Upgrade |
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| MADIT II |
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| PAVE |
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| Physician Designated |
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| SCD-HeFT |
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| Syncope |
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| VF |
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| VT |
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| Not Available |
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| Title |
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| Denominators |
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| Categories |
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