This trial is active, not recruiting.

Conditions heart failure, tachycardia, ventricular
Treatment st. jude medical optisure lead
Sponsor St. Jude Medical
Start date August 2014
End date July 2021
Trial size 1725 participants
Trial identifier NCT02235545, 60045220


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients implanted with St. Jude Medical Optisure Lead
st. jude medical optisure lead
Patients implanted with St. Jude Medical Optisure Lead

Primary Outcomes

Freedom from RV Lead Related Complications
time frame: Date at which all patients have completed their five year follow-up.

Secondary Outcomes

Optisure Lead-Related Complication Rates
time frame: Date at which all patients have completed their five year follow-up.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Optisure Lead Post Approval Study
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.