Trial Outcomes & Findings for Optisure Lead Post Approval Study (NCT NCT02235545)
NCT ID: NCT02235545
Last Updated: 2025-07-30
Results Overview
Freedom from right ventricle (RV) lead related complications within 30 days of implant at 5 years follow-up Due to early termination of study, the sample size at 5 years follow-up was insufficient to perform the pre-specified primary endpoint analysis. The endpoint was evaluated using the Kaplan-Meier method however the hypothesis test was not performed due to insufficient sample size. The percentage freedom from RV lead related complications was summarized through 5-years from attempted RV lead implant. For subjects who experienced RV lead related complication, the time to event will be calculated from the attempted implant to the date that the first event occurred. For subjects that did not experience the complication, the time to event was censored at their last known event-free time point.
Recruitment status
TERMINATED
Target enrollment
1735 participants
Primary outcome timeframe
5 years
Results posted on
2025-07-30
Participant Flow
Participant milestones
| Measure |
St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
St. Jude Medical Optisure Lead: Patients implanted with St. Jude Medical Optisure Lead
|
|---|---|
|
Overall Study
STARTED
|
1735
|
|
Overall Study
Withdrawal Before 12 Month (12M) Follow-up (FU) Visit
|
102
|
|
Overall Study
Deaths Before 12M FU Visit
|
101
|
|
Overall Study
Completed 12M FU Visit
|
1389
|
|
Overall Study
Withdrawals Before 24M FU Visit
|
107
|
|
Overall Study
Deaths Before 24M FU Visit
|
89
|
|
Overall Study
Completed 24M FU Visit
|
1203
|
|
Overall Study
Withdrawals Before 36M FU Visit
|
93
|
|
Overall Study
Deaths Before 36M FU Visit
|
70
|
|
Overall Study
Completed 36M FU Visit
|
1023
|
|
Overall Study
Withdrawals Before 48M FU Visit
|
55
|
|
Overall Study
Deaths Before 48M FU Visit
|
56
|
|
Overall Study
Completed 48M FU Visit
|
483
|
|
Overall Study
Withdrawals Before 60M FU Visit
|
11
|
|
Overall Study
Deaths Before 60M FU Visit
|
7
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1721
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optisure Lead Post Approval Study
Baseline characteristics by cohort
| Measure |
All Enrolled Subjects
n=1735 Participants
Patients implanted with St. Jude Medical Optisure Lead
St. Jude Medical Optisure Lead: Patients implanted with St. Jude Medical Optisure Lead
|
|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
399 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1336 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
106 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1568 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
188 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1409 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
59 Participants
n=5 Participants
|
|
NYHA Class per Blinded Assessor at Baseline, n(%)
Class I
|
179 Participants
n=5 Participants
|
|
NYHA Class per Blinded Assessor at Baseline, n(%)
Class II
|
712 Participants
n=5 Participants
|
|
NYHA Class per Blinded Assessor at Baseline, n(%)
Class III
|
771 Participants
n=5 Participants
|
|
NYHA Class per Blinded Assessor at Baseline, n(%)
Class IV
|
15 Participants
n=5 Participants
|
|
NYHA Class per Blinded Assessor at Baseline, n(%)
Not Available
|
58 Participants
n=5 Participants
|
|
Arrhythmia History, n(%)
Ventricular Arrhythmias
|
564 Participants
n=5 Participants
|
|
Arrhythmia History, n(%)
Atrial Arrhythmias
|
575 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
Cardiac Arrest
|
91 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
CRT - Other
|
9 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
CRT Generator Change
|
8 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
Familial Condition
|
19 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
Heart Failure with Atrial Fibrillation
|
59 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
Heart Failure with Wide QRS
|
379 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
ICD - Other
|
38 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
ICD Generator Change
|
13 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
Ischemic Cardiomyopathy
|
551 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
Non-Ischemic Cardiomyopathy
|
330 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
Reduced ejection fraction with Frequent Dependence on V-Pacing
|
49 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
Syncope
|
29 Participants
n=5 Participants
|
|
Primary CRT-D Indication for Implant, n(%)
Ventricular Tachycardia
|
160 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Subjects with an attempted implant.
Freedom from right ventricle (RV) lead related complications within 30 days of implant at 5 years follow-up Due to early termination of study, the sample size at 5 years follow-up was insufficient to perform the pre-specified primary endpoint analysis. The endpoint was evaluated using the Kaplan-Meier method however the hypothesis test was not performed due to insufficient sample size. The percentage freedom from RV lead related complications was summarized through 5-years from attempted RV lead implant. For subjects who experienced RV lead related complication, the time to event will be calculated from the attempted implant to the date that the first event occurred. For subjects that did not experience the complication, the time to event was censored at their last known event-free time point.
Outcome measures
| Measure |
St. Jude Medical Optisure Lead
n=1735 Participants
Patients with attempted St. Jude Medical Optisure Lead implanted
|
|---|---|
|
Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads.
|
96.3 % pts free from RV related complications
Interval 94.0 to 97.8
|
Adverse Events
Right Ventricle Lead-Related Complications
Serious events: 58 serious events
Other events: 58 other events
Deaths: 323 deaths
Summary of System and/or Procedure Related Complications Not Related to the RV Lead.
Serious events: 134 serious events
Other events: 137 other events
Deaths: 323 deaths
Serious adverse events
| Measure |
Right Ventricle Lead-Related Complications
n=1735 participants at risk
Summary of RV Lead-Related Complications. A complication is an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention (e.g. lead dislodgement requiring repositioning) including RV lead perforations. All RV lead perforations will be reported as complications.
|
Summary of System and/or Procedure Related Complications Not Related to the RV Lead.
n=1735 participants at risk
Summary of System and/or Procedure Related Complications not related to the RV lead. Includes both System/Pule Generator/Lead Related (RA/LV) and Procedure Related Only
|
|---|---|---|
|
Surgical and medical procedures
Cardiac Perforation
|
0.23%
4/1735 • Number of events 4 • Up to 5 years from baseline for each participant
|
0.12%
2/1735 • Number of events 2 • Up to 5 years from baseline for each participant
|
|
Cardiac disorders
Cardiac Tamponade
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Cardiac disorders
Elevated Pacing Thresholds
|
0.40%
7/1735 • Number of events 7 • Up to 5 years from baseline for each participant
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
|
Infections and infestations
Infection
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
2.3%
40/1735 • Number of events 40 • Up to 5 years from baseline for each participant
|
|
Product Issues
Lead Dislodgement or Migration
|
2.1%
37/1735 • Number of events 38 • Up to 5 years from baseline for each participant
|
2.3%
40/1735 • Number of events 48 • Up to 5 years from baseline for each participant
|
|
Product Issues
Lead Fracture
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
|
Product Issues
Lead Noise
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Product Issues
Loss of Capture
|
0.12%
2/1735 • Number of events 2 • Up to 5 years from baseline for each participant
|
0.12%
2/1735 • Number of events 2 • Up to 5 years from baseline for each participant
|
|
Product Issues
Oversensing
|
0.12%
2/1735 • Number of events 2 • Up to 5 years from baseline for each participant
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
|
Product Issues
Pericardial Effusion
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Cardiac disorders
Twiddler's Syndrome
|
0.12%
2/1735 • Number of events 2 • Up to 5 years from baseline for each participant
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
|
Product Issues
Undersensing
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
|
Product Issues
Other
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
|
Product Issues
Abnormal Lead Pacing Impedance
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Product Issues
Acceleration of Arrhythmias
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Device Migration
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Product Issues
Erosion
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
|
Product Issues
Generator Malfunction
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.58%
10/1735 • Number of events 10 • Up to 5 years from baseline for each participant
|
|
Product Issues
Inappropriate Delivery of Therapy
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.29%
5/1735 • Number of events 5 • Up to 5 years from baseline for each participant
|
|
Product Issues
Lead/Port Damage
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.12%
2/1735 • Number of events 2 • Up to 5 years from baseline for each participant
|
|
Product Issues
Phrenic Nerve / Diaphragmatic Stimulation
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.35%
6/1735 • Number of events 6 • Up to 5 years from baseline for each participant
|
|
Product Issues
Thromboemboli
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.29%
5/1735 • Number of events 5 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Atrial Arrhythmia
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Dressler's Syndrome
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Exacerbation of Heart Failure
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Formation of Hematomas or Cysts
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.46%
8/1735 • Number of events 8 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Hemothorax
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
ICD Site Discomfort
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Pericardial Effusion
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Pneumothorax
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Ventricular Arrhythmia
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.12%
2/1735 • Number of events 2 • Up to 5 years from baseline for each participant
|
Other adverse events
| Measure |
Right Ventricle Lead-Related Complications
n=1735 participants at risk
Summary of RV Lead-Related Complications. A complication is an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention (e.g. lead dislodgement requiring repositioning) including RV lead perforations. All RV lead perforations will be reported as complications.
|
Summary of System and/or Procedure Related Complications Not Related to the RV Lead.
n=1735 participants at risk
Summary of System and/or Procedure Related Complications not related to the RV lead. Includes both System/Pule Generator/Lead Related (RA/LV) and Procedure Related Only
|
|---|---|---|
|
Product Issues
Abnormal Lead Defibrillation Impedance <=20 ohms or >=100 ohms
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Product Issues
Abnormal Lead Pacing Impedance <=200 ohms or >=200 ohms
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 2 • Up to 5 years from baseline for each participant
|
|
Product Issues
Elevated Pacing Thresholds
|
0.52%
9/1735 • Number of events 10 • Up to 5 years from baseline for each participant
|
0.75%
13/1735 • Number of events 13 • Up to 5 years from baseline for each participant
|
|
Product Issues
Inappropriate Delivery of Therapy
|
0.29%
5/1735 • Number of events 5 • Up to 5 years from baseline for each participant
|
1.6%
28/1735 • Number of events 32 • Up to 5 years from baseline for each participant
|
|
Product Issues
Lead Dislodgement or Migration
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
|
Product Issues
Lead Noise
|
0.46%
8/1735 • Number of events 8 • Up to 5 years from baseline for each participant
|
0.58%
10/1735 • Number of events 12 • Up to 5 years from baseline for each participant
|
|
Product Issues
Loss of Capture
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
0.29%
5/1735 • Number of events 5 • Up to 5 years from baseline for each participant
|
|
Product Issues
Oversensing
|
1.9%
33/1735 • Number of events 36 • Up to 5 years from baseline for each participant
|
0.92%
16/1735 • Number of events 17 • Up to 5 years from baseline for each participant
|
|
Product Issues
Phrenic Nerve / Diaphragmatic Stimulation
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
0.81%
14/1735 • Number of events 17 • Up to 5 years from baseline for each participant
|
|
Product Issues
Other
|
0.12%
2/1735 • Number of events 2 • Up to 5 years from baseline for each participant
|
0.29%
5/1735 • Number of events 5 • Up to 5 years from baseline for each participant
|
|
Product Issues
Allergic reaction
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
|
Product Issues
Back-Up Device Operation
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
|
Product Issues
Failure to Detect VT/VF
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.23%
4/1735 • Number of events 4 • Up to 5 years from baseline for each participant
|
|
Product Issues
Fatigue (Due to Device Programming)
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Infection
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.46%
8/1735 • Number of events 8 • Up to 5 years from baseline for each participant
|
|
Product Issues
Pacemaker Mediated Tachycardia (PMT)
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
|
Product Issues
Pectoral Stimulation
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.29%
5/1735 • Number of events 5 • Up to 5 years from baseline for each participant
|
|
Product Issues
Undersensing
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Bleeding
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.17%
3/1735 • Number of events 3 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Deep Vein Thrombosis
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.12%
2/1735 • Number of events 2 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Formation of Hematomas or Cysts
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
1.4%
25/1735 • Number of events 25 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
ICD Site Discomfort
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Pericardial Effusion
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Suture Abscess
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Thromboemboli
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.23%
4/1735 • Number of events 4 • Up to 5 years from baseline for each participant
|
|
Surgical and medical procedures
Ventricular Arrhythmia
|
0.00%
0/1735 • Up to 5 years from baseline for each participant
|
0.06%
1/1735 • Number of events 1 • Up to 5 years from baseline for each participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place