Optisure Lead Post Approval Study

Terminated

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: The Optisure lead study is a multi-center, post-approval study that will be performed in compliance with the Conditions for Approval, as agreed upon with the FDA. Patients will be permitted to enroll in the study up to 30 days post-implant of the Optisure lead. Following a successful implant, patients will be followed every 6 months until 60 months (5 years). After patients complete 60 months of follow-up, their participation in the study will end. Patients who are consented prior to implant and for whom an implant is unsuccessful will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician and patient choose to do so.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads.	5 years	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.

Secondary Outcome Measures

Name	Time	Method

Locations (60): Baptist Medical Center Princeton
🇺🇸
Birmingham, Alabama, United States
Phoenix Cardiovascular Research Group
🇺🇸
Phoenix, Arizona, United States
St. Bernards (formerly Cardiology Associates of Northeast Arkansas)
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Jonesboro, Arkansas, United States
Raymond Schaerf, MD
🇺🇸
Burbank, California, United States
Desert Heart Rhythm Consultants
🇺🇸
Palm Springs, California, United States
Cardiac Rhythm Specialists, Inc.
🇺🇸
Reseda, California, United States
San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)
🇺🇸
San Diego, California, United States
Jorge Diaz, M.D. , P.A.
🇺🇸
Lake Mary, Florida, United States
Northside Hospital
🇺🇸
Atlanta, Georgia, United States
Rockford Cardiology Associates
🇺🇸
Rockford, Illinois, United States
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Baptist Medical Center Princeton
🇺🇸Birmingham, Alabama, United States