Heart Failure, Sudden Cardiac Death, Tachyarrhythmias
Conditions
Keywords
ICD, CRTD, Heart Failure, DF4
Brief summary
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
Interventions
DEVICESJ4 connector and RV high voltage SJ4 lead
Standard of care implantation of SJ4 device system
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system. * Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations.
Exclusion criteria
* Be currently participating in a clinical investigation that includes an active treatment arm. * Have a life expectancy of less than 6 months due to any condition. * Be less than 18 years of age.
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 1,701 |
| Total | 1,701 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 461 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Unsuccessful Implant | 4 |
| Overall Study | Withdrawn - Non-Death | 364 |
Baseline characteristics
| Characteristic | SJ4 System Implanted |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 13 |
| Left Ventricular (LV) Ejection Fraction (%) | 29 Percentage STANDARD_DEVIATION 12 |
| New York Heart Association (NYHA) Class Class 1 | 94 participants |
| New York Heart Association (NYHA) Class Class 2 | 541 participants |
| New York Heart Association (NYHA) Class Class 3 | 816 participants |
| New York Heart Association (NYHA) Class Class 4 | 29 participants |
| New York Heart Association (NYHA) Class Not Available | 221 participants |
| Primary Indication for Device Implant CRT-D Upgrade | 65 participants |
| Primary Indication for Device Implant DEFINITE | 5 participants |
| Primary Indication for Device Implant Familial Condition | 31 participants |
| Primary Indication for Device Implant HF Without QRS | 45 participants |
| Primary Indication for Device Implant HF Without Sinus Rhythm | 70 participants |
| Primary Indication for Device Implant HF With Wide QRS | 484 participants |
| Primary Indication for Device Implant ICD Upgrade | 44 participants |
| Primary Indication for Device Implant MADIT II | 228 participants |
| Primary Indication for Device Implant Not Available | 1 participants |
| Primary Indication for Device Implant PAVE | 14 participants |
| Primary Indication for Device Implant Physician Designated | 19 participants |
| Primary Indication for Device Implant SCD-HeFT | 409 participants |
| Primary Indication for Device Implant Syncope | 39 participants |
| Primary Indication for Device Implant VF | 83 participants |
| Primary Indication for Device Implant VT | 164 participants |
| Race/Ethnicity, Customized American Indian Or Alaska Native | 1 participants |
| Race/Ethnicity, Customized Asian | 20 participants |
| Race/Ethnicity, Customized Black or African American | 235 participants |
| Race/Ethnicity, Customized Hispanic/ Black (Puerto Rican) | 1 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 53 participants |
| Race/Ethnicity, Customized Iranian | 1 participants |
| Race/Ethnicity, Customized Middle Eastern | 1 participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 4 participants |
| Race/Ethnicity, Customized Other- Non Hispanic | 2 participants |
| Race/Ethnicity, Customized Persian | 1 participants |
| Race/Ethnicity, Customized White | 1382 participants |
| Region of Enrollment United States | 1701 participants |
| Sex: Female, Male Female | 482 Participants |
| Sex: Female, Male Male | 1219 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 376 / 1,701 |
| serious Total, serious adverse events | 0 / 1,701 |
Outcome results
Primary
Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SJ4 System Implanted | Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector | 96.4 percentage of patients |
Primary
Right Ventricle (RV) Bipolar Capture Thresholds
Time frame: 5 years
Population: Study participants with RV bipolar capture threshold at the 5 year follow up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SJ4 System Implanted | Right Ventricle (RV) Bipolar Capture Thresholds | 0.92 Volts |