SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT00940888
Collaborator
(none)
1,701
1
78
21.8

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
  • Device: SJ4 connector and RV high voltage SJ4 lead

Study Design

Study Type:
Observational
Actual Enrollment :
1701 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
SJ4 Post Approval Study
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Dec 1, 2015

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

  1. Right Ventricle (RV) Bipolar Capture Thresholds [5 years]

  2. Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

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.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT00940888
Other Study ID Numbers:
  • 60020938
First Posted:
Jul 16, 2009
Last Update Posted:
Feb 4, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Abbott Medical Devices
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Primary Outcome
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

[Not Specified]

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
Email gkim@sjm.com
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT00940888
Other Study ID Numbers:
  • 60020938
First Posted:
Jul 16, 2009
Last Update Posted:
Feb 4, 2019
Last Verified:
Jan 1, 2019