SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No treatment: ICD/CRTD-indicated
|
Device: SJ4 connector and RV high voltage SJ4 lead
Standard of care implantation of SJ4 device system
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Bruce Wilkoff, MD, The Clevleland Clinic Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 60020938
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | SJ4 System Implanted |
---|---|
Arm/Group Description | 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). |
Period Title: Overall Study | |
STARTED | 1701 |
COMPLETED | 866 |
NOT COMPLETED | 835 |
Baseline Characteristics
Arm/Group Title | SJ4 System Implanted |
---|---|
Arm/Group Description | 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 Participants | 1701 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
65
(13)
|
Sex: Female, Male (Count of Participants) | |
Female |
482
28.3%
|
Male |
1219
71.7%
|
Race/Ethnicity, Customized (participants) [Number] | |
American Indian Or Alaska Native |
1
0.1%
|
Asian |
20
1.2%
|
Black or African American |
235
13.8%
|
Hispanic or Latino |
53
3.1%
|
Iranian |
1
0.1%
|
Middle Eastern |
1
0.1%
|
Native Hawaiian or Pacific Islander |
4
0.2%
|
Other- Non Hispanic |
2
0.1%
|
Persian |
1
0.1%
|
White |
1382
81.2%
|
Hispanic/ Black (Puerto Rican) |
1
0.1%
|
Region of Enrollment (participants) [Number] | |
United States |
1701
100%
|
New York Heart Association (NYHA) Class (participants) [Number] | |
Class 1 |
94
5.5%
|
Class 2 |
541
31.8%
|
Class 3 |
816
48%
|
Class 4 |
29
1.7%
|
Not Available |
221
13%
|
Left Ventricular (LV) Ejection Fraction (%) (Percentage) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Percentage] |
29
(12)
|
Primary Indication for Device Implant (participants) [Number] | |
CRT-D Upgrade |
65
3.8%
|
DEFINITE |
5
0.3%
|
Familial Condition |
31
1.8%
|
HF With Wide QRS |
484
28.5%
|
HF Without QRS |
45
2.6%
|
HF Without Sinus Rhythm |
70
4.1%
|
ICD Upgrade |
44
2.6%
|
MADIT II |
228
13.4%
|
PAVE |
14
0.8%
|
Physician Designated |
19
1.1%
|
SCD-HeFT |
409
24%
|
Syncope |
39
2.3%
|
VF |
83
4.9%
|
VT |
164
9.6%
|
Not Available |
1
0.1%
|
Outcome Measures
Title | Right Ventricle (RV) Bipolar Capture Thresholds |
---|---|
Description | |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Study participants with RV bipolar capture threshold at the 5 year follow up visit. |
Arm/Group Title | SJ4 System Implanted |
---|---|
Arm/Group Description | 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). |
Measure Participants | 856 |
Mean (90% Confidence Interval) [Volts] |
0.92
|
Title | Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector |
---|---|
Description | |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | SJ4 System Implanted |
---|---|
Arm/Group Description | 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). |
Measure Participants | 1701 |
Number (90% Confidence Interval) [percentage of patients] |
96.4
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | SJ4 System Implanted | |
Arm/Group Description | 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). | |
All Cause Mortality |
||
SJ4 System Implanted | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
SJ4 System Implanted | ||
Affected / at Risk (%) | # Events | |
Total | 0/1701 (0%) | |
Other (Not Including Serious) Adverse Events |
||
SJ4 System Implanted | ||
Affected / at Risk (%) | # Events | |
Total | 376/1701 (22.1%) | |
General disorders | ||
RV Lead or DF4 Connector Related Complication | 50/1701 (2.9%) | 54 |
System and/or Procedure Related Complication | 44/1701 (2.6%) | 64 |
LV Lead Dislodgment or Migration Complication | 21/1701 (1.2%) | 24 |
RA Lead Dislodgement or Migration Complication | 21/1701 (1.2%) | 25 |
System and/or Procedure Related Observation | 38/1701 (2.2%) | 94 |
RV Lead or DF4 Connector Related Observation | 45/1701 (2.6%) | 52 |
Elevated LV Pacing Thresholds Observation | 21/1701 (1.2%) | 24 |
Inappropriate Shock(s) Observation | 33/1701 (1.9%) | 36 |
LV Phrenic Nerve/ Diaphragmatic Stimulation Observation | 51/1701 (3%) | 56 |
RA Oversensing Observation | 40/1701 (2.4%) | 47 |
Infections and infestations | ||
Infection Complication | 36/1701 (2.1%) | 37 |
Surgical and medical procedures | ||
Lead Dislodgement or Migration <30 days after Implant Complication | 21/1701 (1.2%) | 22 |
Bleeding/ Hematoma Observation | 38/1701 (2.2%) | 38 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Grant Kim, Director Clinical Studies |
---|---|
Organization | Saint Jude Medical |
Phone | 818-493-3147 |
gkim@sjm.com |
- 60020938