Optisure Lead Post Approval Study
Optisure Lead Post Approval Study
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.
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prior to implant and for whom an implant is unsuccessful will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician and patient choose to do so.
Inclusion Criteria:
Eligible patients will meet all of the following:
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
Jonesboro, Arkansas 72401, United States
San Diego, California 92103, United States
High Point, North Carolina 27262, United States
St. George, Utah 84790, United States
Shinjuku-Ku, Kanto 162-8666, Japan
Abeno-ku, Osaka 545-8565, Japan
Shimotsuke-shi, Tochigi 329-0498, Japan