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Optisure Lead Post Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 7, 2014
First Posted Date September 10, 2014
Last Update Posted Date January 15, 2021
Actual Study Start Date August 2014
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2014)
Freedom from RV Lead Related Complications [ Time Frame: Date at which all patients have completed their five year follow-up. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 9, 2014)
Optisure Lead-Related Complication Rates [ Time Frame: Date at which all patients have completed their five year follow-up. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 9, 2014)
  • 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. ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Optisure Lead Post Approval Study
Official Title Optisure Lead Post Approval Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ICD/CRT-D indicated patients
Condition
  • Heart Failure
  • Tachycardia, Ventricular
Intervention Device: St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
Study Groups/Cohorts St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
Intervention: Device: St. Jude Medical Optisure Lead
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 13, 2021)
1735
Original Estimated Enrollment
 (submitted: September 9, 2014)
1725
Actual Study Completion Date June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Canada,   Germany,   Japan,   Poland,   Portugal,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02235545
Other Study ID Numbers 60045220
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators
Study Director: Grant Kim Abbott Medical Devices
PRS Account Abbott Medical Devices
Verification Date January 2021