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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
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.

Condition or disease Intervention/treatment
Heart Failure Tachycardia, Ventricular Device: St. Jude Medical Optisure Lead

Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
 Device: St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from RV Lead Related Complications [ Time Frame: Date at which all patients have completed their five year follow-up. ]

Secondary Outcome Measures :
  1. Optisure Lead-Related Complication Rates [ Time Frame: Date at which all patients have completed their five year follow-up. ]

Other Outcome Measures:
  1. Optisure Lead Related Adverse Events [ Time Frame: Date at which all patients have completed their five year follow-up. ]
  2. The annual hazard rate of lead electrical dysfunction [ Time Frame: Date at which all patients have completed their five year follow-up. ]
  3. The annual hazard rate of externalized conductors [ Time Frame: Date at which all patients have completed their five year follow-up. ]
  4. 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. ]
  5. Prevalence of "other insulation anomalies" in "returned leads [ Time Frame: Date at which all patients have completed their five year follow-up. ]
  6. Time from externalized conductors to electrical dysfunction [ Time Frame: Date at which all patients have completed their five year follow-up. ]
  7. 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. ]
  8. 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. ]
  9. Time from externalized conductors to clinical intervention [ Time Frame: Date at which all patients have completed their five year follow-up. ]
  10. 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. ]
  11. 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. ]
  12. 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. ]

Eligibility Criteria
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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
Study Population
ICD/CRT-D indicated patients
Criteria

Inclusion Criteria:

Eligible patients will meet all of the following:

  1. 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).
  2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.
  3. 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.
  4. 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:

  1. 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.
  2. Have a life expectancy of less than 5 years due to any condition.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Grant Kim Abbott Medical Devices
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Abbott Medical Devices:
HV Lead
ICD
CRT-D System
 Treatment of Heart Failure
Treamtent of life-threatening ventricular tachyarrhythmia
Optisure
Additional relevant MeSH terms:
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Heart Failure
Tachycardia
Tachycardia, Ventricular
Heart Diseases
 Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes