Trial Outcomes & Findings for SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients (NCT NCT00940888)
NCT ID: NCT00940888
Last Updated: 2019-02-04
Results Overview
Recruitment status
COMPLETED
Target enrollment
1701 participants
Primary outcome timeframe
5 years
Results posted on
2019-02-04
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
1701
|
|
Overall Study
COMPLETED
|
866
|
|
Overall Study
NOT COMPLETED
|
835
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Unsuccessful Implant
|
4
|
|
Overall Study
Death
|
461
|
|
Overall Study
Withdrawn - Non-Death
|
364
|
|
Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
Baseline characteristics by cohort
| Measure |
SJ4 System Implanted
n=1701 Participants
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).
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
482 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1219 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
235 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
53 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Iranian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other- Non Hispanic
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Persian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1382 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/ Black (Puerto Rican)
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1701 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
Class 1
|
94 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
Class 2
|
541 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
Class 3
|
816 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
Class 4
|
29 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
Not Available
|
221 participants
n=5 Participants
|
|
Left Ventricular (LV) Ejection Fraction (%)
|
29 Percentage
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Primary Indication for Device Implant
CRT-D Upgrade
|
65 participants
n=5 Participants
|
|
Primary Indication for Device Implant
DEFINITE
|
5 participants
n=5 Participants
|
|
Primary Indication for Device Implant
Familial Condition
|
31 participants
n=5 Participants
|
|
Primary Indication for Device Implant
HF With Wide QRS
|
484 participants
n=5 Participants
|
|
Primary Indication for Device Implant
HF Without QRS
|
45 participants
n=5 Participants
|
|
Primary Indication for Device Implant
HF Without Sinus Rhythm
|
70 participants
n=5 Participants
|
|
Primary Indication for Device Implant
ICD Upgrade
|
44 participants
n=5 Participants
|
|
Primary Indication for Device Implant
MADIT II
|
228 participants
n=5 Participants
|
|
Primary Indication for Device Implant
PAVE
|
14 participants
n=5 Participants
|
|
Primary Indication for Device Implant
Physician Designated
|
19 participants
n=5 Participants
|
|
Primary Indication for Device Implant
SCD-HeFT
|
409 participants
n=5 Participants
|
|
Primary Indication for Device Implant
Syncope
|
39 participants
n=5 Participants
|
|
Primary Indication for Device Implant
VF
|
83 participants
n=5 Participants
|
|
Primary Indication for Device Implant
VT
|
164 participants
n=5 Participants
|
|
Primary Indication for Device Implant
Not Available
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Study participants with RV bipolar capture threshold at the 5 year follow up visit.
Outcome measures
| Measure |
SJ4 System Implanted
n=856 Participants
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).
|
|---|---|
|
Right Ventricle (RV) Bipolar Capture Thresholds
|
0.92 Volts
Interval 0.89 to 0.95
|
PRIMARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
SJ4 System Implanted
n=1701 Participants
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).
|
|---|---|
|
Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector
|
96.4 percentage of patients
Interval 95.5 to 97.2
|
Adverse Events
SJ4 System Implanted
Serious events: 0 serious events
Other events: 376 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SJ4 System Implanted
n=1701 participants at risk
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).
|
|---|---|
|
General disorders
RV Lead or DF4 Connector Related Complication
|
2.9%
50/1701 • Number of events 54
|
|
General disorders
System and/or Procedure Related Complication
|
2.6%
44/1701 • Number of events 64
|
|
Infections and infestations
Infection Complication
|
2.1%
36/1701 • Number of events 37
|
|
General disorders
LV Lead Dislodgment or Migration Complication
|
1.2%
21/1701 • Number of events 24
|
|
General disorders
RA Lead Dislodgement or Migration Complication
|
1.2%
21/1701 • Number of events 25
|
|
Surgical and medical procedures
Lead Dislodgement or Migration <30 days after Implant Complication
|
1.2%
21/1701 • Number of events 22
|
|
General disorders
System and/or Procedure Related Observation
|
2.2%
38/1701 • Number of events 94
|
|
General disorders
RV Lead or DF4 Connector Related Observation
|
2.6%
45/1701 • Number of events 52
|
|
General disorders
Elevated LV Pacing Thresholds Observation
|
1.2%
21/1701 • Number of events 24
|
|
General disorders
Inappropriate Shock(s) Observation
|
1.9%
33/1701 • Number of events 36
|
|
General disorders
LV Phrenic Nerve/ Diaphragmatic Stimulation Observation
|
3.0%
51/1701 • Number of events 56
|
|
General disorders
RA Oversensing Observation
|
2.4%
40/1701 • Number of events 47
|
|
Surgical and medical procedures
Bleeding/ Hematoma Observation
|
2.2%
38/1701 • Number of events 38
|
Additional Information
Grant Kim, Director Clinical Studies
Saint Jude Medical
Phone: 818-493-3147
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place