An observational study in Tachyarrhythmias, Sudden Cardiac Death and Heart Failure, sponsored by Abbott Medical Devices. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by Abbott Medical Devices · Observational
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 1,701 is above the median of 200 across 1,678 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
ICD and CRTD indicated patients
Exclusion Criteria:
Device: SJ4 connector and RV high voltage SJ4 lead
Standard of care implantation of SJ4 device system
Right Ventricle (RV) Bipolar Capture Thresholds
Time frame: 5 years
Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector
Time frame: 5 years
| Milestone | SJ4 System Implanted |
|---|---|
| Started | 1701 |
| Completed | 866 |
| Not completed | 835 |
| Withdrew: Unsuccessful implant | 4 |
| Withdrew: Death | 461 |
| Withdrew: Withdrawn - non-death | 364 |
| Withdrew: Lost to follow-up | 6 |
| Volts | SJ4 System Implanted |
|---|---|
| Right Ventricle (RV) Bipolar Capture Thresholds | 0.92 (0.89 to 0.95) |
| percentage of patients | SJ4 System Implanted |
|---|---|
| Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector | 96.4 (95.5 to 97.2) |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SJ4 System Implanted | — | 0/1,701 (0%) | 376/1,701 (22.1%) |
| Event | SJ4 System Implanted |
|---|---|
| LV Phrenic Nerve/ Diaphragmatic Stimulation ObservationGeneral disorders | 51/1701 |
| RV Lead or DF4 Connector Related ComplicationGeneral disorders | 50/1701 |
| RV Lead or DF4 Connector Related ObservationGeneral disorders | 45/1701 |
| System and/or Procedure Related ComplicationGeneral disorders | 44/1701 |
| RA Oversensing ObservationGeneral disorders | 40/1701 |
| System and/or Procedure Related ObservationGeneral disorders | 38/1701 |
| Bleeding/ Hematoma ObservationSurgical and medical procedures | 38/1701 |
| Infection ComplicationInfections and infestations | 36/1701 |
| Inappropriate Shock(s) ObservationGeneral disorders | 33/1701 |
| LV Lead Dislodgment or Migration ComplicationGeneral disorders | 21/1701 |
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.
| Age, Continuous(years) | SJ4 System Implanted |
|---|---|
| Mean | 65 ± 13 |
| Sex: Female, Male(Participants) | SJ4 System Implanted |
|---|---|
| Female | 482 |
| Male | 1219 |
| Race/Ethnicity, Customized(participants) | SJ4 System Implanted |
|---|---|
| American Indian Or Alaska Native | 1 |
| Asian | 20 |
| Black or African American | 235 |
| Hispanic or Latino | 53 |
| Iranian | 1 |
| Middle Eastern | 1 |
| Native Hawaiian or Pacific Islander | 4 |
| Other- Non Hispanic | 2 |
| Persian | 1 |
| White | 1382 |
| Hispanic/ Black (Puerto Rican) | 1 |
| Region of Enrollment(participants) | SJ4 System Implanted |
|---|---|
| United States | 1701 |
| New York Heart Association (NYHA) Class(participants) | SJ4 System Implanted |
|---|---|
| Class 1 | 94 |
| Class 2 | 541 |
| Class 3 | 816 |
| Class 4 | 29 |
| Not Available | 221 |
| Left Ventricular (LV) Ejection Fraction (%)(Percentage) | SJ4 System Implanted |
|---|---|
| Mean | 29 ± 12 |
| Primary Indication for Device Implant(participants) | SJ4 System Implanted |
|---|---|
| CRT-D Upgrade | 65 |
| DEFINITE | 5 |
| Familial Condition | 31 |
| HF With Wide QRS | 484 |
| HF Without QRS | 45 |
| HF Without Sinus Rhythm | 70 |
| ICD Upgrade | 44 |
| MADIT II | 228 |
| PAVE | 14 |
| Physician Designated | 19 |
| SCD-HeFT | 409 |
| Syncope | 39 |
| VF | 83 |
| VT | 164 |
| Not Available | 1 |
Plan to share: No
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Abbott Medical Devices