Optisure Lead Post Approval Study
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ClinicalTrials.gov Identifier: NCT02235545 |
Recruitment Status :
Terminated
(Abbott received FDA approval to transition the ongoing Optisure PAS to EP a new EP-PASSION Real World Evidence methodology)
First Posted : September 10, 2014
Last Update Posted : January 15, 2021
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Condition or disease | Intervention/treatment |
---|---|
Heart Failure Tachycardia, Ventricular | Device: St. Jude Medical Optisure Lead |
Study Type : | Observational |
Actual Enrollment : | 1735 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Optisure Lead Post Approval Study |
Actual Study Start Date : | August 2014 |
Actual Primary Completion Date : | June 30, 2020 |
Actual Study Completion Date : | June 30, 2020 |

Group/Cohort | Intervention/treatment |
---|---|
St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
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Device: St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead |
- Freedom from RV Lead Related Complications [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- Optisure Lead-Related Complication Rates [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- Optisure Lead Related Adverse Events [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- The annual hazard rate of lead electrical dysfunction [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- The annual hazard rate of externalized conductors [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- The annual hazard rate of other visual lead anomalies by each subcategory [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- Prevalence of "other insulation anomalies" in "returned leads [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- Time from externalized conductors to electrical dysfunction [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- Time from other visual lead anomalies by each subcategory to electrical dysfunction [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other) [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- Time from externalized conductors to clinical intervention [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- Time from other visual lead anomalies by each subcategory to clinical intervention [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- Comparison of patients with lead compromise as evidenced by imaging (includes externalized conductors and other visual lead anomalies) to those without lead compromise [ Time Frame: Date at which all patients have completed their five year follow-up. ]
- Comparison of patients with electrical dysfunction to those without electrical dysfunction. [ Time Frame: Date at which all patients have completed their five year follow-up. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Eligible patients will meet all of the following:
- Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
- Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.
- Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
- Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study.
- Have a life expectancy of less than 5 years due to any condition.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235545

Study Director: | Grant Kim | Abbott Medical Devices |
Responsible Party: | Abbott Medical Devices |
ClinicalTrials.gov Identifier: | NCT02235545 |
Other Study ID Numbers: |
60045220 |
First Posted: | September 10, 2014 Key Record Dates |
Last Update Posted: | January 15, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
HV Lead ICD CRT-D System |
Treatment of Heart Failure Treamtent of life-threatening ventricular tachyarrhythmia Optisure |
Heart Failure Tachycardia Tachycardia, Ventricular Heart Diseases |
Cardiovascular Diseases Arrhythmias, Cardiac Cardiac Conduction System Disease Pathologic Processes |